You are viewing a preview of this job. Log in or register to view more details about this job.

Manager, QA Combo Products

Gilead Sciences
Email
At Gilead, Creating Possible drives everything we do. It’s evident in our mission and core values. This is how we built a culture of excellence that is fueled by a passion for improving the lives of people around the world and advancing the care of patients suffering from life-threatening diseases.
At Gilead, we are driven to develop lifesaving products that make a difference for patients around the world. Every day, we to transform the promise of science and technology into breakthrough, innovative therapies that have the power to cure, prevent or treat disease. As a research-based bio pharmaceutical company, we are revolutionizing healthcare by bringing medicines to patients in the areas of unmet need including HIV, AIDS, liver diseases, hematology and oncology, and inflammation and respiratory diseases. When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives.
The Role:
  • Provide QA oversight for all stages of the Design Control process according to FDA 21 CFR Part 820.30, ISO 13485, Health Canada, and Gilead quality system requirements.
  • Interface with internal stakeholders and contract manufacturers to address and resolve complex technical drug-device combination product, process, and quality issues. Acts as an escalation contact for complex and high impact quality issues, concerns and decisions.
  • Support strategic relationships with internal cross-functional teams as well as related CMOs.
  • Support implementation of risk management strategies.
  • Provide QA training as needed for cross-functional stakeholders and CMOs.
  • Provide guidance and impact assessments for Change Control, including DHF/RMF assessments.
  • Write and/or implement changes to controlled documents (e.g., SOPs, specifications, test methods, etc.).
  • Ensures that performance and quality of combination products conform to established standards and regulatory agency requirements.
  • Reviews regulatory documents and provides expertise and guidance in interpreting governmental regulations, agency guidelines and internal policies to assure continued compliance. Participates in regulatory authority inspections.
  • Leads/coordinates investigations, and the development and implementation of corrective and preventative action (CAPA)
  • Anticipates shifts in industry trends and regulatory environment that will impact Gilead’s business needs and positions the function to respond accordingly.
  • Interface with contract manufacturers to address and resolve drug-device related product/process performance issues.
  • Collaborate with R&D during new combination product development and provide input into the design controls process.
  • Work extensively with operating entities to ensure that inspections, statistical process control analyses and audits are conducted on a continuing basis.
  • Participate in annual product reviews and assess changes and product complaints against the DHF and RMF.
     
Knowledge & Skills:
  • Demonstrates understanding and application of QSR/GMP principles, concepts, best practices and standards in the US, Canada, and internationally.
  • Can develop and improve complex concepts, techniques, and standards and new applications based on quality principles and theories.
  • Demonstrates strong knowledge of medical devices, combination products and general pharmaceutical manufacturing.
  • Can provide guidance to solving problems, uses Gilead Quality standards, regulations and industry best practices.
  • Demonstrates knowledge of industry best practices and trends.
  • Demonstrates excellent verbal, written, and interpersonal communication skills.
  • Is comfortable interacting with regulatory agencies as needed.
  • Participates in compliance audit as required
Typical Education & Experience:
  • 7+ years of relevant experience in a GMP environment related field and a BS or BA. OR 5+ years of relevant experience and a MS.
  • Knowledge and experience in quality assurance in a highly regulated manufacturing environment.
  • Previous experience with combination products is required, such as autoinjectors, co-packed kits, pre-filled syringes.
  • QA experience in both clinical and commercial combination products.
  • Strong project management and process improvement skills.
  • Demonstrates understanding of domestic and internal quality systems regulations to adopt best in class systems/processes and drive continuous improvement initiatives.
  • Knowledge of Six Sigma, Define-Measure-Analyze-Improve-Control (DMAIC) methodology, performance measures and quality improvement statistics is preferred.
  • Knowledge of Risk Management principles according to ISO 14971, including the use of risk management tools such as FMEA.
Gilead Core Values:
  • Integrity (doing what's right)
  • Teamwork (working together)
  • Excellence (being your best)
  • Accountability (taking personal responsibility)
  • Inclusion (encouraging diversity)
Gilead Leadership Commitment:
  • I AM BOLD in aspiration and AGILE in execution.
  • I CARE and make time for people.
  • I LISTEN, speak openly and explain the "why."
  • I TRUST others and myself to make sound decisions.
  • I OWN the impact of my words and actions.