Senior Manager, Quality Control
POSITION OBJECTIVE: Manage Quality Control Chemistry personnel and laboratories. Manage Incoming Quality Control personnel and areas. Oversee Quality Control (Chemistry and IQC) Metrics, Investigations, Product Development Activities as related with QC, Product Release and Continuous Improvement.
Essential Job Functions/Responsibilities
- Oversee Quality Control Chemistry testing for In-Process/Bulk, Finished Product, Raw Materials, and Stability at multiple sites.
- Oversee Incoming Quality Control personnel and areas at multiple sites.
- Provide cGMP guidance and training to laboratory personnel regarding FDA guidelines, USP and other compendia, GXP, ICH, and EMEA.
- Setup and maintain efficient laboratory systems and processes for increasing manufacturing output and additional sites/locations.
- Ensure QC laboratories are in state of compliance and are inspection ready.
- Ensure a safe work environment for laboratory personnel with compliance to OSHA requirements.
- Provide review and approval of laboratory data, specifications, performance verifications, certificate of analysis, and no-test forms.
- Conduct laboratory investigations, discrepancy investigations, environmental excursions, out of calibration reports, and CAPA in a timely manner.
- Manage personnel, support departmental budget planning, develop, and maintain Quality Control testing schedules, and instrumentation vendor services.
- Create, Revise, and/or Review operational SOPs, technical documents, protocols, and reports.
- Promote and implement staff training, motivation, and personnel development.
- Complete staff assessments and performance reviews as required ensuring competencies are maintained.
- Participate in personnel development programs to further enhance skills and knowledge relevant to the position.
- Provide input into continuous improvement and metric development and maintenance.
- Serve as SME and provide guidance for method transfers, method qualifications and ICH guidelines, validation activities for UHPLC and GC, and compendial testing.
- Interacts with other function groups for projects planning and QC requirements.
- Review and approve analytical procedures, specifications, and method development.
- Provide a fair assessment and execute processes in hiring new staff members.
- Provide support for customer and manufacturing related needs while maintaining a high level of professionalism.
- Support analytical needs that occur on off-shift hours and multiple sites.
- Review and approve new equipment protocols and method validation, qualification, and transfer protocols.
- Interface with all regulatory agencies and customer audit representatives.
- Prepare quotes and budgets for the QC department as needed.
- Serve as QC SME during regulatory inspections, internal audits, and customer audits.
Required Education & Qualifications
- B.S. or advanced degree in an applicable life-science with a minimum of 5 years of experience in the pharmaceutical manufacturing industry or an Associate degree in an applicable life science with a minimum of 10 years of experience in the pharmaceutical manufacturing industry.
- Proven capabilities in reviewing and approving analytical procedures, specifications, analytical method transfer reports, and method development reports.
- Strong leadership with experience in managing, supervising, and developing employees and teams.
- Excellent verbal and written communication skills.
- Ability to effectively communicate and collaborate with multiple levels within the organization to achieve measurable results.
- Strong focus on quality and safety in a laboratory environment.
- In depth knowledge and experience with cGMP 21 CFR 210/211/820 Quality Systems.
- Working knowledge of laboratory information management systems (LIMS) and experience in leading LIMS implementation and optimization.
- Advanced knowledge and implementation of data integrity principles.
- Advanced organizational and time management skills.
- Experience and involvement with regulatory inspections as well as internal and external audits.
Athenex is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, and other legally protected characteristics.
Athenex is committed to working with and providing reasonable accommodations to individuals with disabilities. If you need a reasonable accommodation because of a disability for any part of the employment process, please notify HR and let us know the nature of your request and your contact information.