Sr Manager, Quality Assurance

Gilead Sciences•La Verne, CA

1d•$143,225 - $185,350•Onsite

About The Position

The Senior Manager, Quality Assurance will be supporting the expanding site manufacturing and technology transfers into the medical device combination products modalities in La Verne, CA in alignment with PDM goals, have identified the need for experience and subject matter expertise within quality to support the medical device and combination product manufacturing.

Requirements

8+ years of experience in a GMP environment related field and a BS or BA.
6+ years of relevant experience and a MS.

Nice To Haves

Demonstrates in-depth knowledge of GMPs and/or GLPs.
Demonstrates in-depth knowledge of QA principles, concepts, industry practices, and standards.
Demonstrates excellent verbal, written, and interpersonal communication skills.
Demonstrates keen understanding of international quality systems regulations to adopt best in class systems/processes, and drive continuous improvement initiatives.
Demonstrates knowledge of Information Systems Technology, understanding of Computer System Validation (CSV) including current electronic records and signature requirements.
Knowledge of Six Sigma, Define-Measure-Analyze-Improve-Control (DMAIC) methodology, performance measures and quality improvement statistical is preferred.
Knowledge of Risk Management tools (e.g., Hazard Analysis and Critical Control Points (HACCP) and / or Failure Mode Effects Analysis (FMEA)) is preferred.
Certification by ASQ (Certified Quality Auditor, Certified Quality Engineer, and Certified Quality Manager) or other industry-recognized professional organizations is preferred.

Responsibilities

Performs a wide variety of activities to ensure compliance with applicable quality objectives and regulatory requirements.
Manages QA personnel, including organizing and prioritizing daily tasks, performing training, and writing performance reviews.
Writes and/or implements changes to controlled documents (e.g., SOPs, specifications, methods, etc.) as needed to ensure defined quality objectives are met.
Implements and maintains programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs) and Good Laboratory Practices (GLPs).
Reviews manufacturing, environmental monitoring and quality control data for in-process and finished products.
Responsible for final release of manufactured products.
Works extensively with operating entities to ensure that inspections, statistical process control analyses and audits are conducted on a continuing basis, to enforce requirements and meet specifications.
May participate in the writing of annual product reviews and the development of training programs regarding all aspects of producing quality products.
Serves as a lead/coordinator of investigations and corrective and preventive action (CAPA) recommendations related to manufactured products.
May lead compliance audits as required.
Interfaces with contract manufacturers to address and resolve more complex product/process performance issues.
Works with Research and Development during new product start-ups, and establishes key checkpoints for new products and processes.
May interface with regulatory agencies as required.