Description:
At Gilead we believe every employee deserves a great leader. As a people leader now or in the future, we expect that you will model and create an environment of inclusion, be intentionally focused on the hiring, development, growth and retention of talent, and empower teams to align and achieve goals.
We are seeking a highly motivated individual to join us as a Senior Manager, Quality Assurance for the Gilead La Verne Batch Record Review and Release team. You will work with the team to ensure quality clinical and commercial product is released in a timely manner and in compliance with Quality and Regulatory requirements.
Responsibilities:
- Manages QA personnel, including organizing and prioritizing daily tasks, performing training, and writing performance reviews.
- Performs a wide variety of activities to ensure compliance with applicable quality objectives and regulatory requirements.
- Manages, prioritizes, and participates in batch record review and release activities, including review of manufacturing, environmental monitoring, and quality control data for in-process and finished products. Responsible for final release of manufactured products.
- Participates in introduction of new clinical/commercial products (e.g., small molecules and biologics) to the site.
- Participates in risk assessments.
- Participates in author, review, and approval of changes to standard operating procedures, specifications, forms, and other controlled documents to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs).
- Participates in site inspection readiness activities.
- Participates in internal and external audits.
- Participates in continuous improvement initiatives.
- Supports generation, and review of metrics and trending data.
- Partner with internal partners to ensure resolution of quality issues.
- Participates in review/approval of Deviations, CAPAs, and Change Management records as required.
- Works on problems that are moderately complex in scope where analysis of situations or data requires in-depth evaluation of various factors. Considerable judgement is required in resolving problems and making routine recommendations.
- Exercises judgement within defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.
Qualifications:
- Bachelors Degree and 8+ years of experience required
- PhD or PharmD preferred
- Experience with batch record review and release of clinical and/or commercial product preferred.
- Experience with biological product processing, formulation, operations, and/or testing preferred.
- Experience with parenteral and aseptic operations; proficiency or familiarity with Annex 1 requirements.
- Experience across broad areas of Quality Assurance and/or Quality Systems.
- Experience with interacting with regulatory agencies.
- Demonstrated ability to develop, coach and mentor employees.
- Excellent interpersonal, verbal, and written communication skills.
- Knowledge of Risk Management tools (e.g., HACCP and FMEA)