Senior Manager, Quality Assurance and Compliance

3 days ago

Sanford, North Carolina, United States Astellas Pharma Full time
About Astellas Gene Therapies

Astellas Gene Therapies is a Center of Excellence within Astellas Pharma, dedicated to developing genetic medicines for patients with rare, life-threatening diseases. Our innovative approach, combined with industry-leading internal manufacturing capabilities and expertise, has established us as a leader in the field. We are currently exploring three gene therapy modalities: gene replacement, exon skipping gene therapy, and vectorized RNA knockdown, with plans to expand our focus and geographic reach under Astellas.

The Role

The Senior Manager, Quality Assurance and Compliance will provide Quality and Compliance oversight to Astellas Gene Therapies. This role is responsible for implementing and overseeing the AGT Supplier Management program, internal audit program, inspection management, and compliance oversight required to support GMP manufacturing operations at AGT GMP operations as well as GMP suppliers. Key responsibilities include:

  • Implementing and improving programs in alignment with corporate directives and best practices.
  • Negotiating and maintaining quality agreements with suppliers.
  • Managing the supplier qualification program, including maintaining the approved supplier list, ensuring supplier qualification is maintained, and ensuring compliance with supplier audit schedules.
  • Conducting quality audits at suppliers and contract manufacturers, reporting results to project teams and management, and interacting with teams to ensure corrective actions are implemented.
  • Directing the internal audit program, including ensuring annual schedules are approved, audits are executed, and corrective actions are implemented to improve compliance.
  • Establishing and leading inspection readiness programs to ensure successful licensure of new gene therapy products and acting as host for corporate, QP, and health authority inspections.
Requirements

To be successful in this role, you will need:

  • A Bachelor's degree in a scientific or technical discipline, and 10+ years of pharmaceutical experience in biotechnology or pharmaceutical industry in quality or quality systems in people or team leadership roles.
  • 4+ years of related management experience, including consistently creating opportunities for colleagues to improve their knowledge and skills needed in their current job.
  • Expert-level knowledge of regulatory requirements (US and International) related to GMP manufacturing and testing of drug product, including data integrity, quality control testing standards, quality systems, drug development, and commercial production.
  • Proven QA experience, including successful implementation and oversight of Quality Management Systems, inspection readiness, and health authority inspection management in a cGMP biologics manufacturing environment.
  • Demonstrated ability to work in a fast-paced team environment, meet deadlines, and prioritize work from multiple projects.
Benefits

Astellas Pharma offers a comprehensive benefits package, including:

  • Medical, dental, and vision insurance.
  • Generous paid time off options, including vacation, sick time, and national holidays.
  • 401(k) match and annual company contribution.
  • Company-paid life insurance.
  • Annual corporate bonus and quarterly sales incentive for eligible positions.
  • Long-term incentive plan for eligible positions.
  • Referral bonus program.

Astellas Pharma is an equal opportunity employer and welcomes applications from diverse candidates. All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or on the basis of disability.

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