Associate Director Quality Assurance

Associate Director, QA Change Control, Pharmaceuticals, Consultant

Summary

Our client, a biopharmaceutical company dedicated to developing and commercializing novel therapies for diseases with significant unmet needs, particularly in eye care, has engaged with GForce to identify a Quality Assurance consultant. This person will be responsible for the review and processing of manufacturing Deviations and laboratory OOS and review of manufacturing and laboratory-related Change Controls within the established QMS system. This role will also be responsible for the approval of Certificates of Analysis, manufacturing batch record review, and product disposition.

Duties / Expectations of Role

Support QA activities for early-phase (preclinical through clinical phase I/II) clinical development programs

Ensure compliance with GMP in addition to internal policies and procedures

Provide strategic QA input to cross functional teams, including Clinical, Regulatory Affairs, Analytical Development and CMC

Serve as QA representative on development project teams and advise on risk mitigation strategies

Contribute to the authoring and review of SOPs, protocols, reports and specifications

Process and approve change controls, OOS and deviations within the QMS system

Review and approve CMO’s master batch records, analytical documents and validation protocols

Review executed batch records and disposition batches per internal policies and procedures

Participate in CMO and internal operations meetings

Mandatory Requirements

Bachelor’s or advanced degree in life science or a related field

Sterile injection products experience

10 years of experience in Quality Assurance within the pharmaceutical / Biotechnology industry

Experience in early-phase clinical development and a sound understanding of the drug development life cycle

Strong knowledge of deviation and change control systems.

Laboratory background with method methods

Experience with investigations using root cause analysis, CAPA and CAPA effectiveness

ASQ Certification Preferred

Term & Start

6-month contract with intent to convert to FTE

Hybrid 2-3 days a week in Irvine, CA OR remote depending on candidate location/experience