Director of Quality Assurance
KCAS Bio, Kansas City, MO, United States
Overview
Performing critical work that impacts our industry and our world’s health while problem solving and innovating in the field – that is what the Director of Quality Assurance at KCAS Bio gets to do every day. The Director of Quality Assurance leads one or more QA departments, interacts with executive management, clients, and regulatory agencies regarding quality systems, audits, and inspections, and guides interpretation and implementation of health agency regulatory requirements.
As a member of the Senior Leadership Team, you will oversee the quality management system at KCAS Bio, meet department goals and objectives, and maintain expert knowledge of bioanalytical scientific trends and regulatory requirements.
Responsibilities
Assure Quality systems are designed and performing to meet industry, regulatory, and executive management requirements
Initiate employee hire, promotion, discharge, or transfer
Participate in the selection process for subordinate personnel including determining recruiting criteria, interviewing, and performing reference checks
Perform annual performance evaluations for direct reports
Require and monitor training for subordinates to develop them to their potential
Effectively use delegation to develop subordinates
Perform career planning for subordinates
Provide encouragement and positive reinforcement to subordinates; require subordinate leadership staff to do the same
Participate in the development of short and long-range goals and objectives, implement and attain short and long-range goals and objectives, and assure that year-end goals are attained
Assure that all departmental management staff are working in concert with each other
Coordinate activities of the department with related activities of other departments to ensure efficiency and economy
Understand, communicate and cascade communication from Executive management
Be knowledgeable of site departmental budget and monitor and analyze cost against budget
Overall responsibility for the Quality Assurance operation, compliance and site department goals including budget management
Interact with clients relating to quality audits, respond to client audit reports, and understand client needs/expectations
Complete client QA questionnaires and respective QA-assigned sections of RFIs
Forecast, recommend and justify strategies to accommodate growth when needed (space, equipment, staffing)
Establish policies and procedures to ensure that QA operations maintain a high level of QA expertise and comply with related regulatory policies, OSHA and company SOPs/policies
Audit reports, data, internal processes, computer system validations, facility, and procedures to support management to improve data integrity, reduce error rates, efficiency, and maintain compliance
Manage internal auditing program including planning, conduct and reporting of audits
Conduct annual management review of the quality system
Manage digital quality systems, including eQMS administration, archiving, and related scanning
Ensure appropriate validation of methodology and instrumentation per regulatory requirement/industry expectation
Oversee CAPA system to ensure effective continuous improvement
Coordinator and back-up within the department
Perform and track vendor quality assessments
Review/update SOPs to reflect current practice and regulatory requirements
Maintain expert knowledge of bioanalytical scientific trends as well as regulatory requirements
Perform complex quality assignments with understanding of underlying scientific principles
Recommend and institute systems and programs to improve safety, work quality, cost saving and productivity
Effectively interface with various functional units, groups or departments in the company
Qualifications
Bachelor’s degree in a related field
Director-level experience preferred
10 years industry-related experience, including 2 years supervisory experience
Experience in a CRO or pharmaceutical company is preferred
Broad knowledge of regulatory requirements applicable to areas managed
Extensive knowledge of processes applicable to subordinate groups
Awareness of industry trends related to areas managed
Computer proficiency
Perform all aspects of the job in a way that supports the company brand and the company mission, vision, and values
What you’ll get
Our benefits include, and extend beyond, the traditional package. At KCAS Bio, you will enjoy company sponsored events like food trucks, family days and spirit days. You will grow in your career with KCAS University. You will be able to connect with like-minded employees to further KCAS Bio's approach to key areas such as wellness, inclusion, and community outreach. You will engage as an owner in our stock ownership program. You will have access to the latest technology. And you will be able to invest in the community with paid time off to volunteer.
Who we are
We are a fast-growing contract research organization (CRO) headquartered in Kansas City, pioneering the latest drug development in both human and animal health fields. We advance both great science AND great people.
EEO and how to apply
KCAS Bio is proud to be an Equal Opportunity Employer. We provide equal employment opportunities without regard to race, color, religion, national origin, ancestry, marital status, veteran status, age, disability, pregnancy, genetic information, sex, sexual orientation, gender identity, or any other legally protected category. We recruit qualified candidates without regard to citizenship status based on internal processes that enable us to hire the right candidates consistent with the appropriate U.S. Immigration framework. We work with and provide reasonable accommodations to individuals with disabilities and for sincerely held religious beliefs, observances, and practices. Anyone who needs reasonable accommodation may email kcasrecruiting@kcasbio.com or call 913-248-3000 (for TTY assistance call 711) and ask for Human Resources.
IND123
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Performing critical work that impacts our industry and our world’s health while problem solving and innovating in the field – that is what the Director of Quality Assurance at KCAS Bio gets to do every day. The Director of Quality Assurance leads one or more QA departments, interacts with executive management, clients, and regulatory agencies regarding quality systems, audits, and inspections, and guides interpretation and implementation of health agency regulatory requirements.
As a member of the Senior Leadership Team, you will oversee the quality management system at KCAS Bio, meet department goals and objectives, and maintain expert knowledge of bioanalytical scientific trends and regulatory requirements.
Responsibilities
Assure Quality systems are designed and performing to meet industry, regulatory, and executive management requirements
Initiate employee hire, promotion, discharge, or transfer
Participate in the selection process for subordinate personnel including determining recruiting criteria, interviewing, and performing reference checks
Perform annual performance evaluations for direct reports
Require and monitor training for subordinates to develop them to their potential
Effectively use delegation to develop subordinates
Perform career planning for subordinates
Provide encouragement and positive reinforcement to subordinates; require subordinate leadership staff to do the same
Participate in the development of short and long-range goals and objectives, implement and attain short and long-range goals and objectives, and assure that year-end goals are attained
Assure that all departmental management staff are working in concert with each other
Coordinate activities of the department with related activities of other departments to ensure efficiency and economy
Understand, communicate and cascade communication from Executive management
Be knowledgeable of site departmental budget and monitor and analyze cost against budget
Overall responsibility for the Quality Assurance operation, compliance and site department goals including budget management
Interact with clients relating to quality audits, respond to client audit reports, and understand client needs/expectations
Complete client QA questionnaires and respective QA-assigned sections of RFIs
Forecast, recommend and justify strategies to accommodate growth when needed (space, equipment, staffing)
Establish policies and procedures to ensure that QA operations maintain a high level of QA expertise and comply with related regulatory policies, OSHA and company SOPs/policies
Audit reports, data, internal processes, computer system validations, facility, and procedures to support management to improve data integrity, reduce error rates, efficiency, and maintain compliance
Manage internal auditing program including planning, conduct and reporting of audits
Conduct annual management review of the quality system
Manage digital quality systems, including eQMS administration, archiving, and related scanning
Ensure appropriate validation of methodology and instrumentation per regulatory requirement/industry expectation
Oversee CAPA system to ensure effective continuous improvement
Coordinator and back-up within the department
Perform and track vendor quality assessments
Review/update SOPs to reflect current practice and regulatory requirements
Maintain expert knowledge of bioanalytical scientific trends as well as regulatory requirements
Perform complex quality assignments with understanding of underlying scientific principles
Recommend and institute systems and programs to improve safety, work quality, cost saving and productivity
Effectively interface with various functional units, groups or departments in the company
Qualifications
Bachelor’s degree in a related field
Director-level experience preferred
10 years industry-related experience, including 2 years supervisory experience
Experience in a CRO or pharmaceutical company is preferred
Broad knowledge of regulatory requirements applicable to areas managed
Extensive knowledge of processes applicable to subordinate groups
Awareness of industry trends related to areas managed
Computer proficiency
Perform all aspects of the job in a way that supports the company brand and the company mission, vision, and values
What you’ll get
Our benefits include, and extend beyond, the traditional package. At KCAS Bio, you will enjoy company sponsored events like food trucks, family days and spirit days. You will grow in your career with KCAS University. You will be able to connect with like-minded employees to further KCAS Bio's approach to key areas such as wellness, inclusion, and community outreach. You will engage as an owner in our stock ownership program. You will have access to the latest technology. And you will be able to invest in the community with paid time off to volunteer.
Who we are
We are a fast-growing contract research organization (CRO) headquartered in Kansas City, pioneering the latest drug development in both human and animal health fields. We advance both great science AND great people.
EEO and how to apply
KCAS Bio is proud to be an Equal Opportunity Employer. We provide equal employment opportunities without regard to race, color, religion, national origin, ancestry, marital status, veteran status, age, disability, pregnancy, genetic information, sex, sexual orientation, gender identity, or any other legally protected category. We recruit qualified candidates without regard to citizenship status based on internal processes that enable us to hire the right candidates consistent with the appropriate U.S. Immigration framework. We work with and provide reasonable accommodations to individuals with disabilities and for sincerely held religious beliefs, observances, and practices. Anyone who needs reasonable accommodation may email kcasrecruiting@kcasbio.com or call 913-248-3000 (for TTY assistance call 711) and ask for Human Resources.
IND123
#J-18808-Ljbffr