AD, Quality Assurance - Contract
- Provide Quality oversight and leadership for cGMP activities related to monoclonal antibody products produced at CMOs/CTLs.
- Collaborate with operating entities (AD/QC, Manufacturing, and CMOs/CTLs) to ensure that clinical MCB/WCB, drug substance and drug products meet all required quality standards and specifications or are appropriately investigated.
- Provide effective QA support for the manufacturing and disposition of stability and clinical drug product lots.
- Review and approve drug substance and drug product development and GMP manufacturing documentation to assess suitability of the available package to advance the program from Phase 1b drug product manufacture and beyond.
- Ensure that Quality policies and practices at CMOs/CTLs adhere to approved Quality Agreements, monitor and provide corrective action recommendations to compliance issues and/or observations as they arise. Manage and coordinate process monitoring and continuous improvement initiatives per cGMP requirements, as required.
- Facilitate resolution of quality issues in a timely manner. Coordinate communication with contract manufacturers and internal cross functional teams for quality issues.
- Ensure compliance with the Quality Systems such as change control, quality investigations, and CAPA resolutions. Management of assigned QA operation tasks in accordance to SOPs.
- May assist with review of regulatory filings, providing input into answering questions from health authorities, and providing input into presentations of materials during regulatory inspections/partner audits, as applicable.
- Lead and perform QA audits/inspections (internal and external) as assigned.
- Lead and represent QA in multi-departmental meetings & project sub-teams.
- Manage, oversee, develop and guide contract support personnel.
- Maintain current knowledge of industry standards and regulatory requirements for products developed or manufactured by Company, techniques/approaches and systems utilized by Company.
- Other duties as assigned by the QA Management.
- Bachelor of Arts/Sciences (BA/BS) degree in a biological sciences discipline is required.
- 10+ years' experience in a cGMP regulated environment, with exhibited knowledge or proficiency in Quality Assurance.
- Experience in cell line development and upstream processing is a must; experience with downstream processing and sterile fill/finish is highly desirable.
- Organizational and management skills to communicate to multi-discipline project groups.
- Ability to comprehend technical information and regulatory expectations.
- Proficiency with MS software applications, including MS Word, MS Excel, MS Project, MS Power Point.
- Proficiency with technical summary report reviews required, with exceptional organizational attention to detail.
- Knowledge of industry standards, guidance documents, and regulatory requirements from Phase I to Phase III is required.
Job Type: Contract
Location: Brisbane, CA
Job ID: 20-03340
Date Updated: April 22, 2020