Corden Pharma - A Full-Service CDMO
Associate Director, Safety and Health
Corden Pharma - A Full-Service CDMO, Boulder, Colorado, United States, 80301
Overview
CordenPharma
is a leading full-service Contract Development and Manufacturing Organization (CDMO) specializing in active pharmaceutical ingredients (APIs), excipients, drug products (DPs), and packaging. With around 3,000 employees worldwide, we help pharmaceutical and biotech companies manufacture medicines with the ultimate goal of improving people’s lives. Our network, spanning Europe and the U.S., provides flexible and specialized solutions across six technology platforms: Peptides, Lipids & Carbohydrates, Injectables, Highly Potent & Oncology, Small Molecules, and Oligonucleotides. We strive for excellence in supporting this network and are committed to delivering the highest quality products for patient well-being.
Our People Vision
We strive for excellence. We share our passion. Together, we make a difference in patients\' lives.
Summary The
Associate Director
will be responsible for developing, implementing, and continually improving Health and Safety Programs to ensure compliance with regulatory requirements and promote a safe working environment. They will champion a strong safety culture throughout the organization, and work with leaders across all departments to develop and implement a holistic and proactive approach to safety.
Essential Duties And Responsibilities Include the following. Other duties may be assigned.
Drives and leads the development, integration, and management of Health & Safety programs, processes, and initiatives in support of the vision and growth objectives of CPC
Champions a Health and Safety Excellence culture across the organization
Develops and maintains strategies to prevent incidents, injuries, illnesses, and incidents by implementing systematic approaches, safety protocols, and robust training programs across employee populations
Ownership for maintaining ISO 45001 Certification Program
Designs effective control systems to ensure compliance with local, state, and federal regulations, including the development and implementation of safety policies and risk assessments
Establishes H&S goals and objectives to align with site EHS strategy. Develops and manages company-specific benchmarks and KPIs to manage successful progress toward these goals
Oversees the planning and implementation of safety and compliance training programs, providing guidance to maintain consistent programs
Oversees the performance of audits and inspections to ensure compliance, evaluate performance, identify corrective action, and implement follow-up assessments
Oversees and manages contract relationships for safety systems and services
Prepares for and participates in regulatory agency inspections
Creates an environment of continuous improvement by incorporating lessons learned, detailed root cause analyses, and best practices proactively
Establishes and maintains key relationships and influence within all levels of the organization to integrate H&S objectives into operational focuses, drive continuous H&S improvement, and gain support for needed deployment resources
Anticipates future industry trends and proactively develops and implements plans for H&S capabilities that will scale as the company grows and evolves
Fosters collaboration across functions promoting the exchange of information, consistency, and a culture of continuous improvement
Collaborates on manufacturing operations safety plans and systems to ensure compliance and employee safety
Liaise and collaborate with regulatory agencies, local law enforcement, fire department, and community Emergency Response Teams
Leadership & Budget Responsibilities
Directly supervises Safety employees in the SHES Department
Carries out management and leadership responsibilities in accordance with Corden Pharma Colorado policies and applicable laws
Recommends, implements, and manages effective organizational change to improve safety culture
Ability to collaborate across multiple levels of the organization
Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performances, rewarding, and disciplining employees; and addressing complaints and resolving problems. Supports a positive, healthy, and flexible work environment that encourages employees and coworkers to develop their full potential.
Safety & Environmental Responsibilities Every individual is personally responsible for the safety and environmental aspects of his or her activities in the workplace. Each employee is expected to perform their job duties in a safe manner utilizing all their knowledge, training, ability, and experience.
Quality Responsibilities Corden Pharma Colorado (CPC) is a manufacturer of a variety of pharmaceutical products. In following Current Good Manufacturing Practices (cGMP), CPC manufactures in accordance with the US Food and Drug Administration (FDA), International Council for Harmonisation Q7 (ICH), and other global regulations as applicable. This is critical as it is our mission to not place patients at risk due to inadequate safety, quality, or efficacy. CPC’s Quality Management System, which incorporates cGMP, is designed to deliver this quality objective. Attainment is produced through the requisite participation and commitment of all staff across departments and at all levels within the company. cGMP is the part of Quality Management System ensuring products are consistently produced to accurate quality standards. Adherence to clearly defined procedures, in compliance with the principles of cGMP, is required when performing operations across Corden Pharma Colorado.
Qualifications To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
EDUCATION And/or EXPERIENCE
Experience with the application of Lean Methodologies to safety programs
Experience with Serious Injury and Fatality (SIF) Prevention
Experience implementing EHS Data Management Systems
RCA experience with TapRoot, or similar systematic approach to problem-solving
Major construction project safety exposure
Emergency response experience, especially as incident commander
Bachelor’s Degree in Occupational Health & Safety, Safety Engineering, or a related field
Proven experience of 10 years of leadership in a Health and Safety role
Experience in complex industrial environments such as chemical, oil & gas, or similar heavily regulated industries
In-depth knowledge of general industry Safety and Health standards with OSHA, NFPA, ANSI, and other regulatory/advisory agencies
Experience in OSHA PSM-regulated environment
Experience with ISO 45001 certification
Language Skills Ability to read, analyze, and interpret the most complex documents. Ability to respond effectively to the most sensitive inquiries or complaints. Ability to write speeches and articles using original or innovative techniques or style. Ability to make effective and persuasive speeches and presentations on controversial or complex topics to top management, public groups, and/or board of directors.
REASONING ABILITY Ability to interpret an extensive variety of complex technical concepts and regulations for diverse audiences. Adept at risk assessment, problem-solving, and critical thinking.
CERTIFICATES, LICENSES, REGISTRATIONS Safety Certification in one of the following: Certified Safety Professional (CSP), Certified Safety Manager (CSM), or Certified Safety and Health Manager (CSHM).
PHYSICAL DEMANDS The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to sit. The employee is required to talk and hear. The employee is occasionally required to stand, walk, and work with hands. Specific vision abilities required by this job include close vision, distance vision, and ability to adjust focus. May be required to climb ladders and scaffolds. Occasionally required to wear a respirator. Willingness to occasionally work required nights/weekends/on-call.
WORK ENVIRONMENT The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is occasionally exposed to moving mechanical parts, fumes or airborne particles, low levels of toxic or caustic chemicals, and outside weather conditions. The noise level in the work environment is usually moderate.
CORE COMPETENCIES These are the specific areas of knowledge, skill and ability that are important for successful job performance.
Knowledge of complex industrial equipment operations
Ability to analyze and recommend strategies for improving the work environment related to health and safety, while understanding and supporting the business objectives
Capability to analyze complex interrelated regulations and formulate effective compliance strategies to ensure SHES business objectives are met
Capable of inspiring change, mentoring colleagues, and driving continuous improvement in a lean, fast-paced environment
Demonstrated leadership, ethics, and negotiating and technical skills
Knowledge of Industrial Hygiene programs
Strong skills in root cause analysis and safety program development are required
Excellent communication skills with the ability to influence employees at all levels to engage in continuous improvement of health and safety programs
Detail-oriented with strong organizational skills to manage multiple tasks efficiently
SALARY Actual pay will be based on your skills and experience.
Benefits
401(k) matching - Corden Pharma will contribute 100% of the first 6% - 100% vested after 2 years of service
Accident Plan
Critical Illness Insurance
Dental Insurance
Disability Insurance
Employee Assistance Program
Flexible Spending Account
Health Insurance PPO/HSA
Hospital Indemnity Plan
ID Theft Protection
Life Insurance
Paid Parental Leave
Tuition Reimbursement
Wellness Program
Vacation – Three Weeks 1st Year
Vision Insurance
EQUAL OPPORTUNITY EMPLOYER Corden Pharma provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws. Corden Pharma embraces fair hiring practices.
This post will expire on February 13, 2025
#J-18808-Ljbffr
is a leading full-service Contract Development and Manufacturing Organization (CDMO) specializing in active pharmaceutical ingredients (APIs), excipients, drug products (DPs), and packaging. With around 3,000 employees worldwide, we help pharmaceutical and biotech companies manufacture medicines with the ultimate goal of improving people’s lives. Our network, spanning Europe and the U.S., provides flexible and specialized solutions across six technology platforms: Peptides, Lipids & Carbohydrates, Injectables, Highly Potent & Oncology, Small Molecules, and Oligonucleotides. We strive for excellence in supporting this network and are committed to delivering the highest quality products for patient well-being.
Our People Vision
We strive for excellence. We share our passion. Together, we make a difference in patients\' lives.
Summary The
Associate Director
will be responsible for developing, implementing, and continually improving Health and Safety Programs to ensure compliance with regulatory requirements and promote a safe working environment. They will champion a strong safety culture throughout the organization, and work with leaders across all departments to develop and implement a holistic and proactive approach to safety.
Essential Duties And Responsibilities Include the following. Other duties may be assigned.
Drives and leads the development, integration, and management of Health & Safety programs, processes, and initiatives in support of the vision and growth objectives of CPC
Champions a Health and Safety Excellence culture across the organization
Develops and maintains strategies to prevent incidents, injuries, illnesses, and incidents by implementing systematic approaches, safety protocols, and robust training programs across employee populations
Ownership for maintaining ISO 45001 Certification Program
Designs effective control systems to ensure compliance with local, state, and federal regulations, including the development and implementation of safety policies and risk assessments
Establishes H&S goals and objectives to align with site EHS strategy. Develops and manages company-specific benchmarks and KPIs to manage successful progress toward these goals
Oversees the planning and implementation of safety and compliance training programs, providing guidance to maintain consistent programs
Oversees the performance of audits and inspections to ensure compliance, evaluate performance, identify corrective action, and implement follow-up assessments
Oversees and manages contract relationships for safety systems and services
Prepares for and participates in regulatory agency inspections
Creates an environment of continuous improvement by incorporating lessons learned, detailed root cause analyses, and best practices proactively
Establishes and maintains key relationships and influence within all levels of the organization to integrate H&S objectives into operational focuses, drive continuous H&S improvement, and gain support for needed deployment resources
Anticipates future industry trends and proactively develops and implements plans for H&S capabilities that will scale as the company grows and evolves
Fosters collaboration across functions promoting the exchange of information, consistency, and a culture of continuous improvement
Collaborates on manufacturing operations safety plans and systems to ensure compliance and employee safety
Liaise and collaborate with regulatory agencies, local law enforcement, fire department, and community Emergency Response Teams
Leadership & Budget Responsibilities
Directly supervises Safety employees in the SHES Department
Carries out management and leadership responsibilities in accordance with Corden Pharma Colorado policies and applicable laws
Recommends, implements, and manages effective organizational change to improve safety culture
Ability to collaborate across multiple levels of the organization
Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performances, rewarding, and disciplining employees; and addressing complaints and resolving problems. Supports a positive, healthy, and flexible work environment that encourages employees and coworkers to develop their full potential.
Safety & Environmental Responsibilities Every individual is personally responsible for the safety and environmental aspects of his or her activities in the workplace. Each employee is expected to perform their job duties in a safe manner utilizing all their knowledge, training, ability, and experience.
Quality Responsibilities Corden Pharma Colorado (CPC) is a manufacturer of a variety of pharmaceutical products. In following Current Good Manufacturing Practices (cGMP), CPC manufactures in accordance with the US Food and Drug Administration (FDA), International Council for Harmonisation Q7 (ICH), and other global regulations as applicable. This is critical as it is our mission to not place patients at risk due to inadequate safety, quality, or efficacy. CPC’s Quality Management System, which incorporates cGMP, is designed to deliver this quality objective. Attainment is produced through the requisite participation and commitment of all staff across departments and at all levels within the company. cGMP is the part of Quality Management System ensuring products are consistently produced to accurate quality standards. Adherence to clearly defined procedures, in compliance with the principles of cGMP, is required when performing operations across Corden Pharma Colorado.
Qualifications To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
EDUCATION And/or EXPERIENCE
Experience with the application of Lean Methodologies to safety programs
Experience with Serious Injury and Fatality (SIF) Prevention
Experience implementing EHS Data Management Systems
RCA experience with TapRoot, or similar systematic approach to problem-solving
Major construction project safety exposure
Emergency response experience, especially as incident commander
Bachelor’s Degree in Occupational Health & Safety, Safety Engineering, or a related field
Proven experience of 10 years of leadership in a Health and Safety role
Experience in complex industrial environments such as chemical, oil & gas, or similar heavily regulated industries
In-depth knowledge of general industry Safety and Health standards with OSHA, NFPA, ANSI, and other regulatory/advisory agencies
Experience in OSHA PSM-regulated environment
Experience with ISO 45001 certification
Language Skills Ability to read, analyze, and interpret the most complex documents. Ability to respond effectively to the most sensitive inquiries or complaints. Ability to write speeches and articles using original or innovative techniques or style. Ability to make effective and persuasive speeches and presentations on controversial or complex topics to top management, public groups, and/or board of directors.
REASONING ABILITY Ability to interpret an extensive variety of complex technical concepts and regulations for diverse audiences. Adept at risk assessment, problem-solving, and critical thinking.
CERTIFICATES, LICENSES, REGISTRATIONS Safety Certification in one of the following: Certified Safety Professional (CSP), Certified Safety Manager (CSM), or Certified Safety and Health Manager (CSHM).
PHYSICAL DEMANDS The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to sit. The employee is required to talk and hear. The employee is occasionally required to stand, walk, and work with hands. Specific vision abilities required by this job include close vision, distance vision, and ability to adjust focus. May be required to climb ladders and scaffolds. Occasionally required to wear a respirator. Willingness to occasionally work required nights/weekends/on-call.
WORK ENVIRONMENT The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is occasionally exposed to moving mechanical parts, fumes or airborne particles, low levels of toxic or caustic chemicals, and outside weather conditions. The noise level in the work environment is usually moderate.
CORE COMPETENCIES These are the specific areas of knowledge, skill and ability that are important for successful job performance.
Knowledge of complex industrial equipment operations
Ability to analyze and recommend strategies for improving the work environment related to health and safety, while understanding and supporting the business objectives
Capability to analyze complex interrelated regulations and formulate effective compliance strategies to ensure SHES business objectives are met
Capable of inspiring change, mentoring colleagues, and driving continuous improvement in a lean, fast-paced environment
Demonstrated leadership, ethics, and negotiating and technical skills
Knowledge of Industrial Hygiene programs
Strong skills in root cause analysis and safety program development are required
Excellent communication skills with the ability to influence employees at all levels to engage in continuous improvement of health and safety programs
Detail-oriented with strong organizational skills to manage multiple tasks efficiently
SALARY Actual pay will be based on your skills and experience.
Benefits
401(k) matching - Corden Pharma will contribute 100% of the first 6% - 100% vested after 2 years of service
Accident Plan
Critical Illness Insurance
Dental Insurance
Disability Insurance
Employee Assistance Program
Flexible Spending Account
Health Insurance PPO/HSA
Hospital Indemnity Plan
ID Theft Protection
Life Insurance
Paid Parental Leave
Tuition Reimbursement
Wellness Program
Vacation – Three Weeks 1st Year
Vision Insurance
EQUAL OPPORTUNITY EMPLOYER Corden Pharma provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws. Corden Pharma embraces fair hiring practices.
This post will expire on February 13, 2025
#J-18808-Ljbffr