Senior Director of Quality Control
The Sr. Director of Quality Control is responsible for leading and managing the GMP Clinical and GMP commercial QC Departments. This individual will be responsible for overseeing all aspects of quality control, including developing and implementing quality systems and procedures, training, and development of staff, and ensuring compliance with regulatory requirements. The Sr. Director of Quality Control will also be responsible for managing the day-to-day operations of the departments and ensuring that all product testing and inspection processes are carried out in a timely and accurate manner. The Sr. Director of Quality Control will be responsible for conducting investigations into any quality control issues and implementing corrective actions as necessary. Additionally, requires leadership, communication, and problem-solving skills. Works directly with internal and external clients.
- Recruit, interview, and hire new staff.
- Oversee the daily workflow of the department.
- Leading teams responsible for QC Microbiology, Environmental Monitoring, Raw Material Testing, in-process, lot release, stability, drug substance and final drug products.
- Provide constructive and timely performance evaluations.
- Handle discipline and termination of employees in accordance with company policy.
- Develop and review product Certificate of Analysis, Test methods and assay history records.
- Establish and maintain effective working relationships with internal and external stakeholders, including suppliers, regulatory agencies, and customers.
- All other related duties as assigned.
- Lead the Quality Control staff responsible for raw material and finished product release, stability, in-process, cleaning verification testing. Ensures that delivery of data is accurate and on-time.
- Provide mentorship to direct reports and maintain clear communication on performance to direct reports.
- Owner of the Quality control metrics to assess overall and individual performance to ensure continuous improvement opportunities are being assessed and applied.
- Manage QC inputs to Annual Product Quality Reviews and Quality Management Reviews.
- Oversee trending of commercial product quality (Drug Substance, Drug Product, Finished Product) and commercial QC analytical method performance.
- Manage QC deviations, CAPAs, and change controls for clinical and commercial products.
- Responsible for all systems, processes, and resources for Quality Control support to Manufacturing Operations.
- Owner of Third-Party testing lab relationships.
- Collaborate with Manufacturing, MSET, AR&D, and Validation to ensure effective technology transfer from internal departments and external companies.
- Oversee Management team to ensure subject matter expertise is instilled to develop scientists’ motivation, education, efficiency, and performance management of individuals.
- Coordinate with Analytical R&D resources to optimize test methods and execution to streamline laboratory functions, operations and improve overall quality of such functions.
- Oversee and support method validation and verification activities, and method transfer between sites for clinical/commercial products.
- Work with Quality Assurance Department to improve and sustain an effective and efficient quality management system.
- Oversee Specification and Stability protocol generation programs, specification stability protocols, instrument qualification protocols, validation/qualification reports, SOPs, and CoAs.
- Responsible for GMP-compliant analytical laboratory and safe working environment.
- Requires the ability to lead and motivate team members.
- Interest in developing and implementing new technologies.
- Ability to work with other department heads to advance Company goals and initiatives.
- Ability to set priorities in a rapidly changing environment.
- Ability to work toward common goals by supporting, encouraging, and sharing information with colleagues, both internal and external.
- Technically capable of determining the root cause of a problem, offering potential solutions, and working with others to correct problems.
- Ability to speak, write, listen, and present information in a logical and articulate manner to internal and external teams.
- Excellent oral and written communication skills, auditing skills, and proven ability to work autonomously and manage effectively in a matrix environment.
- A hands-on, "roll up the sleeves" professional willing to try innovative things, have a driving sense of urgency and an experienced "make it happen" orientation within a Program-based, matrix work environment.
- Expert analytical method development experience highly desired.
- Strong technical writing skills.
Education and Experience:
- B.S. / M.S. in chemistry, pharmaceutical sciences, or related discipline with at least 5 years QC management experience and 10+ years related experience preferred (CDMO experience preferred)
- Demonstrated continued growth and responsibility in management and leadership experience.
- Expert level knowledge of drug product and raw material release and stability testing, industry expectations, methods, and systems for pharmaceutical products.
- Experience authoring CMC portions of regulatory filings is highly desired.
- Expert level knowledge of Industry Compendia (USP/Pharm EU, etc.).
- Expert knowledge of global cGMP expectations, FDA/EU/ICH Quality requirements, and USP/EP/JP.
- Experience overseeing QC Audits, QC Inspections, ensuring PAI readiness, contributing to BLA/CMC filings, and hosting FDA/EMEA audits & inspections.
- Requires 10+ years of GMP experience