Senior Manager, Quality Assurance
Specific Job Responsibilities
- Perform a wide variety of activities to ensure compliance with applicable quality objectives and regulatory requirements.
- Manage QA personnel, including organizing/prioritizing daily tasks, performing training, and writing performance reviews.
- Write and/or implement changes to controlled documents (e.g., SOPs, specifications, methods) to meet quality objectives.
- Implement and maintain programs/processes to ensure high-quality products and compliance with GMPs/GLPs.
- Review manufacturing, environmental monitoring, and quality control data for in-process and finished products.
- Responsible for final release of manufactured products.
- Work with operating entities to ensure inspections, statistical process control analyses, and audits are conducted continuously.
- May participate in annual product reviews and development of training programs.
- Lead/coordinator of investigations and CAPA recommendations; may lead compliance audits.
- Interface with contract manufacturers to resolve complex product/process performance issues.
- Work with R&D during new product start-ups and establish key checkpoints.
- May interface with regulatory agencies as required.
Basic Qualifications
- 8+ years of experience in a GMP environment related field and a BS or BA.
- 6+ years of relevant experience and an MS.
Preferred Qualifications
- In-depth knowledge of GMPs and/or GLPs.
- In-depth knowledge of QA principles, concepts, industry practices, and standards.
- Excellent verbal, written, and interpersonal communication skills.
- Knowledge of international quality systems regulations; drive continuous improvement.
- Knowledge of Computer System Validation (CSV), including electronic records and signature requirements.
- Knowledge of Six Sigma/DMAIC and quality improvement statistical methods (preferred).
- Knowledge of Risk Management tools (HACCP and/or FMEA) (preferred).
- ASQ certification (or other industry-recognized certification) (preferred).
Compensation/Benefits
- Salary range: $143,225.00 - $185,350.00. Discretionary annual bonus, discretionary stock-based long-term incentives, paid time off, and benefits package including company-sponsored medical, dental, vision, and life insurance plans.
Application Instructions
- For current Gilead employees and contractors: apply via the Internal Career Opportunities portal in Workday.