Technical Manager II
1 DNA Way South San Francisco, CA 94080 | Contract
Our client is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious or life-threatening medical conditions. They are among the world' s leading biotech companies, with multiple products on the market and a promising development pipeline.
- The job description applies to the tasks and responsibilities of the Quality Systems Manager(s), External Quality.
- The job holder is responsible for the implementation and maintenance of compliant Quality Systems in the meaning of cGMP compliant processes for the management of Contract Manufacturing Organisations producing drug substances and drug products and according to its quality standards, regulatory and legal requirements (i.e. HMG, ICH, EU, GMP, cGMP, PIC/S, WHO, ISO).
Activities in detail:
- Change Control activities
- Acts as Head of Local Change Control /change controller (Quality role) for technical changes related to validated manufacturing processes, systems, methods, qualified equipment and materials.
- Subject matter expert for the Change Control System in cross-functional boards, commissions and expert groups by interfacing the quality, supply chain, and CMC regulatory affairs operations while advising on systems requirements.
- Acts as subject matter expert for discrepancy processes for deviations concerning validated systems, methods, qualified equipment and materials.
- Corrective and Preventive Actions (CAPA) activities
- Acts as subject matter expert for CAPA processes concerning validated systems, methods, qualified equipment and materials.
- GMP documentation (e.g. SOP/GSP/SRD) Takes the lead in setting up and updating
- GMP documentation according to current GMP requirements
- Acts as an inspector in internal audits and participate in regulatory inspections to guarantee inspection/audit readiness
- Involvement of senior management Proactively involves senior management in compliance issues concerning quality, safety and efficacy, as required.
- Liaise with internal partners to ensure compliance to internal, contractual and authority requirements.
- Performs trainings for quality site managers and site managers for quality role in GTCM, DSM investigator and CAPA Manager
- Regional support for APQRs of CMO Create, review and evaluate CMO-related sections of the APR / PQR and coordinate the internal data collection for the summary evaluation report. Issue the Roche APQR Summary Module
- Genentech experience is preferred but not required.
- Ability to interpret and relate Quality standards as they relate to CMOs Ability to make sound quality decisions with an E2E approach Ability to communicate clearly and professionally in English both in writing and verbally Must be able to build relationships cross functionally Ability to influence internal groups
- Trackwise, Excel, PowerPoint and Word experience required.
- Strong time management skills and ability to prioritize own work.
- Experience reviewing documentation (quality checks).
- Strong interpersonal, influence, initiative, task management and negotiation skills.
- Ability to manage multiple, changing priorities in a fast-paced environment is essential.
- Strong attention to detail is required.
- 4-6 years pharmaceutical experience is required.
- At least four years direct experience in quality assurance for pharmaceutical operations is strongly preferred.
- BS or BA in a relevant scientific discipline or equivalent and demonstrated working knowledge of quality assurance and manufacturing principles.