Technical Manager II in South San Francisco, CA at Apex Life Sciences

Date Posted: 8/7/2018

Job Snapshot

Job Description



Apex Life Sciences is looking to hire a Technical Manager with a large biotech company. The candidate is responsible for the implementation and maintenance of compliant Quality Systems in the meaning of cGMP compliant processes for the management of Contract Manufacturing Organizations producing drug substances and drug products.


Duties:

Change Control:

  • Acts as Head of Local Change Control /change controller (Quality role) for technical changes related to validate 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.

Discrepancy activities

  • 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

Inspection/audit readiness

  • 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 APQR Summary Module

Skills:

  • Ability to interpret and relate Quality standards as they relate to company and 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.
  • Use programs such as: 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.

Education:

  • 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.

If you are interested, please send your resume to awoods@apexlifesciences.com

EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law.