GeneCoda has been engaged to identify and evaluate candidates for a Senior Manager / Associate Director of Quality Control (QC) located in the Research Triangle Park, NC marketplace.
About Our Client:
Our client is an innovative, clinical-stage biopharmaceutical company developing medically important pharmaceutical products in Oncology and other therapeutic areas with unmet needs.
The Senior Manager of QC will provide quality control support for biologics clinical development programs and future commercial manufacturing. Our client’s products span early to late stage clinical development biologics manufactured by various contract manufacturers. Our client has monoclonal antibody products in parenteral dosage form in various phases of clinical development, as well as in preparation for market authorization application and commercial production.
The Biologics Quality (i.e. both QA and QC) team is responsible for quality operations for Biologics CMC projects in compliance with applicable guidelines and regulations. The Senior Manager of QC will work with the Head of Biologics QA to provide leadership and integrate and coordinate activities in alignment with other departments and company goals. He/she will manage personnel and projects based on short-term and long-term objectives.
- In collaboration with other Quality groups, develop and provide data integrity expertise to support all development and commercial CMC programs.
- In collaboration with the CMC and QA teams, develop, review or approve controlled documents, including analytical methods, specifications, analytical and process validation protocols and final reports.
- In collaboration with the CMC and QA teams, develop internal processes and procedures for reference standard management program to support late phase and commercial CMC programs.
- In collaboration with the CMC and QA teams, develop internal processes and procedures to provide quality oversight of late phase and commercial stability programs.
- Develop, maintain and improve additional QC processes to enhance efficiencies and compliance.
- Managing QC resources (budget and personnel) to support Biologics programs.
- Support or manage CMO and CTO compliance of quality systems, including but not limited to change control, deviations, investigations, out of specification (OOS) results, process, equipment and facility validation, analytical methods/tech transfer, retain sample management, reference standard management, annual product review, and adherence to quality agreements.
- In collaboration with CMC and QA teams, provide quality support for analytical investigations (OOS, OOT, cleaning validation, etc.) performed by CDMOs.
- Support product complaints, stock recovery/product recall, field alert and other quality events and regulatory actions as needed.
- Participate in supplier qualification audits and due diligence CDMO site visits, and direct QC “Person-in-Plant” execution as needed.
- Evaluate and manage regulatory compliance of CDMO’s including preparation for PAI and other regulatory inspections.
- Establish and manage metrics for supplier quality, as well as indicators for internal QC performance efficiencies.
- In collaboration with Quality Systems and GMP QA teams, support negotiation of quality agreements with CDMO’s as applicable.
- In collaboration with CMC and Regulatory Affairs teams, prepare, review or approve comprehensive reports (i.e. stability reports, relevant CMC regulatory filings, and annual product reviews).
- Travel approximately 10-20% of time (domestic and international); the frequency of travel may increase for a short duration in order to meet critical business needs.
Education: Bachelor of Science degree in a scientific discipline or related field. An advanced, post-graduate degree is desirable.
Experience and Qualifications:
- 5 or more years of experience in GMP Quality Control, Quality Assurance, Quality Systems, Microbiology or Analytical Development in the biotechnology or pharmaceutical industry.
- Hands-on experience in providing Analytical, QC or Microbiology support for clinical and commercial manufacturing, tech transfers, product launches and ongoing commercial supplies.
- Knowledge and expertise in principles and practices of cGMP for small-molecule solid oral forms, including manufacture of drug substances; biologic drug substance or aseptic manufacturing experience is a plus.
- Experience with CDMO management (e.g. worked with or for CDMO’s).
- Broad working knowledge of global regulations (i.e. ICH guidance, FDA/EMEA GMP regulations, etc.) for manufacturing, packaging and distributing drug substances and drug products.
- Direct interaction with FDA, EMA or other regulatory agencies during regulatory inspections is a plus.
- Demonstrated ability to broadly assess regulatory compliance audit findings and implement appropriate CAPAs at CDMO’s.
- Experience with assessing validation requirements for manufacturing processes, facilities and equipment.
- Passion for problem solving and teamwork.
- Strong collaborative skills, team player mentality.
- Effective decision-making and problem-solving.
- Ability to troubleshoot, identify root causes and systematically resolve problems.
- Ability to prioritize, organize and manage multiple projects simultaneously.
- Excellent interpersonal skills.
- Excellent verbal and written communication skills.
GeneCoda refers qualified applicants for all jobs without regard to race, color, religion, creed, age, sex, disability, marital status, national origin, pregnancy, family medical history or genetic information, sexual orientation or preference, Vietnam Era Veteran status or other protected military status or any other status protected by federal, state or local law.