Director, Quality Assurance
Bachem Holding AG, Vista, CA, United States
About the Company
Bachem is a leading, innovation-driven company specializing in the development and manufacture of peptides and oligonucleotides. With over 50 years of experience and expertise Bachem provides products for research, clinical development and commercial application to pharmaceutical and biotechnology companies worldwide and offers a comprehensive range of services. Bachem operates internationally with headquarters in Switzerland and locations in Europe, the US and Asia. The company is listed on the SIX Swiss Exchange. For further information, see www.bachem.com.
Brief overview The Director of Quality Assurance, in conjunction with the VP of Quality, maintains systems to assure compliance regulatory and client requirements for all relevant GMP operations carried out within the organization for the manufacture of drug substances in compliance with FDA and international regulatory requirements for research, pre-clinical, clinical and commercial Active Pharmaceutical Ingredients (APIs). The person in this role will oversee Quality Assurance (QA) personnel, will ensure the review/approval of draft, and executed batch records, specifications, test methods, release and stability data, raw material testing reports, validation protocols and reports, and validation records. This position will also manage systems for tracking of document control, training, internal and external auditing, client audits, CAPAs, and deviations. The Director of Quality Assurance is responsible for coordination with all departments in the company to ensure that timelines are adhered to and company monthly and annual goals are met or exceeded. In addition, this position will be responsible for improving quality systems, processes and procedures to increase the overall level of compliance for the site and business.
What you will do
Maintain and improve the company’s quality system per FDA ICH Q7 requirements for drug substances
Manage, support and participate in regulatory inspections, manage customer Quality audits, serving as the point of contact and represent QA on project teams.
Manage Quality Data Analytics and provide KPI data to QA
Oversee and conduct GMP, ICH and ISO training to comply with regulatory requirements
Manage Quality Management Review and APR
Oversee the document control function, including issuing records, maintaining electronic and hard copies of master records, and maintaining hard copies of history records
Oversee quality functions, including but not limited to deviations, CAPA, NCMR, annual product quality reviews, calibration program, DCR system, change control system, raw material release, QC record review, stability studies review, and batch record review
Establish head count needs for the QA group and recruit, train and manage personnel to meet the business needs of the company
Perform cGMP internal audits and cGMP surveillance across the BAM sites
Resolve day to day issues within functional departments and provide compliance assistance as needed, ensuring continuous improvement and effectiveness of the quality management system.
Oversee work of direct reports; distribute workload, and cross train staff on different quality areas. Interview, hire, train, develop and manage employees.
All responsibilities are to be performed in compliance with company policy as well as with applicable domestic and international regulatory requirements.
Qualifications
Bachelor’s Degree in Science related field or
Master’s Degree or Ph.D. in Science related field (Preferred)
10+ years work experience in a Quality field for GMP company
5+ years management experience (Preferred)
Knowledge of GMP, ISO, FDA, EU and international regulations
Ability to direct, mentor and motivate others
Excellent written and oral communication skills including data analytics
Basic computer knowledge, including Microsoft Word, Excel and PowerPoint
Ability to manage critical projects to deadlines as part of an interdisciplinary team
Ability to effectively organize, multitask, and work in a fast-paced, deadline driven work environment
Ability to communicate in a proactive and solution-focused manner, including keeping management aware of potential issues
Detail oriented with the ability to troubleshoot and resolve problems
Communicate effectively and ability to function well in a team environment
Presentation skills, technical writing and editing skills
Ability and willingness to work flexible/extended hours and moderate travel as needed to support the business
Certifications: QPA, CQA,CQE (Preferred)
Salary Range:
$167,354.40-$230,112.30
Placement of new hires in these wage ranges is based on several factors including education, skill sets, experience, and training.
Total Rewards We offer all Team Members a total rewards package including competitive pay, annual performance bonus, a generous benefit package with comprehensive Medical/Dental/Vision coverage, 401(k) plan with employer contribution, and paid vacation, personal and sick days.
Corporate Social Responsibility Bachem takes responsibility for future generations by a careful handling of resources and avoiding environmental risks. We continually improve our ecological performance and develop and implement new approaches for enhancing employees’ environmental awareness. EcoVadis has awarded Bachem Gold Medal status in their assessment of Bachem.
Bachem Americas is an Equal Opportunity Employer As an equal opportunity employer, we celebrate the diversity of our team and are committed to building an inclusive workplace where individuals are hired and advanced based on merit, skills, and qualifications. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status, or other legally protected status.
Please note: unsolicited resumes from recruitment agencies will not be considered.
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Brief overview The Director of Quality Assurance, in conjunction with the VP of Quality, maintains systems to assure compliance regulatory and client requirements for all relevant GMP operations carried out within the organization for the manufacture of drug substances in compliance with FDA and international regulatory requirements for research, pre-clinical, clinical and commercial Active Pharmaceutical Ingredients (APIs). The person in this role will oversee Quality Assurance (QA) personnel, will ensure the review/approval of draft, and executed batch records, specifications, test methods, release and stability data, raw material testing reports, validation protocols and reports, and validation records. This position will also manage systems for tracking of document control, training, internal and external auditing, client audits, CAPAs, and deviations. The Director of Quality Assurance is responsible for coordination with all departments in the company to ensure that timelines are adhered to and company monthly and annual goals are met or exceeded. In addition, this position will be responsible for improving quality systems, processes and procedures to increase the overall level of compliance for the site and business.
What you will do
Maintain and improve the company’s quality system per FDA ICH Q7 requirements for drug substances
Manage, support and participate in regulatory inspections, manage customer Quality audits, serving as the point of contact and represent QA on project teams.
Manage Quality Data Analytics and provide KPI data to QA
Oversee and conduct GMP, ICH and ISO training to comply with regulatory requirements
Manage Quality Management Review and APR
Oversee the document control function, including issuing records, maintaining electronic and hard copies of master records, and maintaining hard copies of history records
Oversee quality functions, including but not limited to deviations, CAPA, NCMR, annual product quality reviews, calibration program, DCR system, change control system, raw material release, QC record review, stability studies review, and batch record review
Establish head count needs for the QA group and recruit, train and manage personnel to meet the business needs of the company
Perform cGMP internal audits and cGMP surveillance across the BAM sites
Resolve day to day issues within functional departments and provide compliance assistance as needed, ensuring continuous improvement and effectiveness of the quality management system.
Oversee work of direct reports; distribute workload, and cross train staff on different quality areas. Interview, hire, train, develop and manage employees.
All responsibilities are to be performed in compliance with company policy as well as with applicable domestic and international regulatory requirements.
Qualifications
Bachelor’s Degree in Science related field or
Master’s Degree or Ph.D. in Science related field (Preferred)
10+ years work experience in a Quality field for GMP company
5+ years management experience (Preferred)
Knowledge of GMP, ISO, FDA, EU and international regulations
Ability to direct, mentor and motivate others
Excellent written and oral communication skills including data analytics
Basic computer knowledge, including Microsoft Word, Excel and PowerPoint
Ability to manage critical projects to deadlines as part of an interdisciplinary team
Ability to effectively organize, multitask, and work in a fast-paced, deadline driven work environment
Ability to communicate in a proactive and solution-focused manner, including keeping management aware of potential issues
Detail oriented with the ability to troubleshoot and resolve problems
Communicate effectively and ability to function well in a team environment
Presentation skills, technical writing and editing skills
Ability and willingness to work flexible/extended hours and moderate travel as needed to support the business
Certifications: QPA, CQA,CQE (Preferred)
Salary Range:
$167,354.40-$230,112.30
Placement of new hires in these wage ranges is based on several factors including education, skill sets, experience, and training.
Total Rewards We offer all Team Members a total rewards package including competitive pay, annual performance bonus, a generous benefit package with comprehensive Medical/Dental/Vision coverage, 401(k) plan with employer contribution, and paid vacation, personal and sick days.
Corporate Social Responsibility Bachem takes responsibility for future generations by a careful handling of resources and avoiding environmental risks. We continually improve our ecological performance and develop and implement new approaches for enhancing employees’ environmental awareness. EcoVadis has awarded Bachem Gold Medal status in their assessment of Bachem.
Bachem Americas is an Equal Opportunity Employer As an equal opportunity employer, we celebrate the diversity of our team and are committed to building an inclusive workplace where individuals are hired and advanced based on merit, skills, and qualifications. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status, or other legally protected status.
Please note: unsolicited resumes from recruitment agencies will not be considered.
#J-18808-Ljbffr