Sr. Quality Assurance Specialist (Biotechnology)
|Location||South San Francisco, CA|
Our growing biotechnology client in Los Angeles has experienced tremendous success with their oncology drug and needs to hire a Quality Assurance Operations Lead in their South San Francisco office. The QA Operations Lead leads and manages the quality operations activities and assures overall compliance of clinical and commercial manufacturing and global distribution activities. You will have primary oversight of quality of drug substance, drug product, and/or finished product manufacturing, testing, labeling, packaging, and distribution. This position will oversee lot release operations and work performed by the Contract Manufacturing Organizations (CMO), contract laboratories, and/or Commercial Business Partners ensuring timely delivery of quality products and services throughout the Global Supply Chain.
- Serve as Quality Operations tactical lead on core projects related to Chemistry, Manufacturing, and Controls (CMC), overseeing all QA operational compliance activities including requirements of Global Commercial Partnerships, as required
- Provide leadership and direct the compliance oversight of CMOs and Partners associated with commercial drug substance, drug product, and/or finished product manufacturing and distribution
- Disposition Drug Substance, Drug Product, and/or Finished Product as required
- Ensure appropriate quality systems are in place to support product release in a compliant and timely manner, and routinely monitor performance in an effort to optimize quality and efficiency
- Ensure compliance to Global Regulatory Requirements as they relate to CMC and Quality. Exercise judgement on complex quality issues using thorough understanding of quality philosophy and regulations
- Ensure Global Labeling is compliant with Regulatory requirements and product characteristics
- Prepare written quality impact assessments related to product quality issues with Clinical Trial Materials and Commercial Products
- Create and coordinate Quality Agreements between CMOs, and Partners as needed. Ensure compliance with Agreements is maintained
- Organize, facilitate, and attend cross-functional meetings as the QA representative and Quality Subject Matter Expert (SME), as required
- Provide Quality support on process validation activities to support launch of late-stage and commercial materials, as required
- Manage and evaluate changes associated with products. Ensure that CMOs and/or Partners have up to date records related to product quality and are informed of any changes or issues that may impact the product in their region
- Support preparation and participate in regulatory inspections, CMOs and/or Partner sites. Ensure CMOs are inspection ready for any of the regions where products are distributed
- Support Internal Audit Program as required.
- Actively interface with and provide support to Global Supply Chain group to develop processes, meet compliance requirements, and develop Good Distribution Practices in all regions
- Approve specifications, Master Batch Records, analytical methods, technical reports, protocols, and SOPs to ensure compliance with cGMP and internal procedures
- Perform quality review of manufacturing documents, including executed batch records, deviations, investigations, complaints, changes, validation, and technology transfer documents from CMOs and/or Partners.
- Relay product impacting quality issues such as, manufacturing changes, non-conformances, and product complaint systems to internal and external stakeholders.
- Assist in any recall activities of products, including recalls in territories managed by Partners.
- Assist in obtaining information from CMOs and/or Partners for Annual Product Review (APR) and provide APR Report to Partners as required.
- B.S. degree in a scientific discipline
- 10-15 years of QA experience working in commercial quality operations in the pharmaceutical or biotechnology industry, with specific experience in GXP quality assurance auditing and GXP regulations, or combined experience working in Quality control and/or Manufacturing
- Thorough understanding of pharmaceutical regulatory compliance requirements with the ability to provide applicable guidance to team members
- Previous experience with analytical testing, test methods, and method validation
- Comprehensive working knowledge of local, state, federal, and international regulations pertaining to GXP and ICH guidelines
- Complete and thorough understanding of regulatory compliance requirements for US FDA, European Union, and Health Canada
- Prior experience with Health Authority Audits
Please follow the link below to submit your application for Sr. Quality Assurance Specialist (Biotechnology).