For Current Gilead Employees and Contractors:
Please log onto your Internal Career Site to apply for this job. Job Description
Quality Assurance delivers on Gilead’s commitment to bring life-changing therapies to patients through the robust QA processes and systems. Our approach is agile, innovative and collaborative and our teams are genuinely committed to the rapid delivery of safe life changing therapies.
As part of the broader Pharmaceutical Development & Manufacturing (PDM) team you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives.
You will see the tangible results of your contributions, where every individual matters, and everyone has a chance to enhance their skills through on-going development. Our scientific focus has resulted in marketed products that are benefiting hundreds of thousands of people, a pipeline of late-stage drug candidates, and unmatched patient access programs to ensure medications are available to those who could otherwise not afford them. By joining QA within PDM, you will further our mission to address unmet medical needs and improve life by advancing the care of patients with life-threatening diseases.
The Manager, Quality Assurance is a high visibility role within Gilead with global reach. We are seeking a Quality Assurance professional who is able to facilitate critical escalation meetings with Senior Management. In addition, the Manager, Quality Systems will support the advancement of Gilead’s brand protection/security program through the development of new programs and processes.
- Facilitates meetings to notify Management of critical quality issues
- Lead the execution of product actions in the marketplace, including agency status reporting
- Manage regulatory notifications to agencies, including field alerts, drug notifications, and quality defect reports
- Lead cross-functional activities to support the advancement of Gilead’s brand protection/security program
- Support investigations involving health authorities, law enforcement, and internal stakeholders
- Develop, lead, and implement risk management principles to evaluate potential product and geographic risks
- Provides expert guidance on regulatory and industry standards and expectations
- Educate and create awareness of Gilead’s programs with internal/external stakeholders
- 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
Knowledge, Experience & Skills:
- 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.
- 8+ years of experience in a GMP environment related field and a BS or BA.
- 6+ years of relevant experience and a MS.
- Experience with critical investigations, field alerts, drug notifications, or defect reporting
- Demonstrates the ability to maintain confidential and material information
- Strong interpersonal and collaboration skills; must be able to positively influence employees who are working with the normal chain of command in order to achieve results.
- Strong attention detail and the ability to manage multiple projects in a dynamic enivornment
- Working knowledge in the application of risk management
If this is not the right move for you now but remain interested in a career at Gilead Sciences please connect with us via our talent community: https://gilead.avature.net/Gilead
Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercialises innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead’s therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.
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