Quality Assurance Compliance Supervisor

2 weeks ago

Westborough, Massachusetts, United States Astellas Pharmaceuticals Full time


Position: Supervisor, Quality Assurance Compliance

Are you eager to contribute to a diverse team dedicated to pioneering therapies for patients? At Astellas, we are committed to the development and delivery of innovative and effective medications for healthcare providers and patients alike.

Astellas Pharma Inc. operates in over 70 countries globally, focusing on transforming innovative science into medical solutions that provide value and hope to patients and their families.

Our commitment to addressing unmet medical needs, coupled with our ethical business practices, allows us to enhance global health.

Astellas Institute for Regenerative Medicine (AIRM), a subsidiary of Astellas Pharma Inc., specializes in the advancement and commercialization of stem cell and regenerative medicine therapies.

As an R&D-driven global pharmaceutical entity, Astellas aims to improve health worldwide through the provision of innovative and dependable pharmaceutical products.

AIRM boasts a top-tier R&D team and is exploring a wide array of disease indications, including macular degeneration and other ocular conditions, as well as vascular and autoimmune diseases.

AIRM's intellectual property portfolio encompasses pluripotent stem cell platforms, including both embryonic and induced pluripotent stem cells, alongside various cell-based therapy research initiatives.

AIRM is based in Massachusetts.

Role Overview:

The Supervisor, Quality Assurance Compliance position is responsible for overseeing and executing essential QA compliance activities to support GMP manufacturing initiatives as AIRM progresses through clinical trials and commercialization.

The ideal candidate will promote compliance across a wide spectrum of Quality Assurance domains and collaborate closely with skilled colleagues in Manufacturing, Quality Control, and Materials Management to ensure high-quality standards and value delivery for our patients.

Key Responsibilities:

  • Manage and develop the QA Compliance team responsible for reviewing executed Manufacturing batch records, QC test records, raw material inspection records, and calibration records.
  • Collaborate with cross-functional stakeholders on quality events (e.g., deviations, Corrective/Preventative Actions (CAPAs)), assisting in investigations and ensuring quality records are well-documented, technically sound, and provide comprehensive root cause analysis and risk assessment.
  • Act as a resource knowledgeable in GMP Self-Inspection/Internal Audits, ensuring compliance with Astellas procedures and domestic/international GMP regulations.
  • Oversee contract manufacturing organizations (CMOs), managing information requests, reviewing CMO work, and following up on compliance-related matters.
  • Develop compliant Quality processes and procedures to meet new compliance requirements and enhance existing practices.
  • Participate in strategic initiatives related to new projects and initiatives as required.
  • Aggregate monthly metrics, identifying, planning, and executing continuous improvement opportunities for process efficiencies and compliance enhancements to benefit departmental operations and the organization.
  • Ensure cGMP compliance through direct oversight and education of team members.
  • Provide coaching, mentoring, professional development, and performance management to junior Quality Assurance staff as appropriate.

Qualifications:

BS/BA or equivalent in Life Sciences, Engineering, or Chemistry with 7+ years of relevant Quality Assurance experience in a GMP-regulated environment, or 5+ years with a Master's degree.

Consideration will be given to candidates with a minimum of 10+ years of industry experience in biotechnology and/or pharmaceutical quality, manufacturing, or other fields requiring high technical proficiency and attention to detail, in lieu of a Life Sciences or equivalent degree.

Previous experience in a Supervisory or Lead role is essential. Demonstrated knowledge of cGMPs for biotechnology is required, along with a working understanding of ICH Q7, Q8, Q9, Q10, and other international regulatory standards.

Ability to interpret regulatory guidelines and industry standards to make objective, risk-based decisions and apply sound Quality-by-Design principles is crucial.

Experience in presenting outcomes to management, proficiency in deviation investigation techniques, root cause analysis methods, CAPA effectiveness verification, and product impact assessments is necessary. Familiarity with the Microsoft Office suite (including Excel and PowerPoint) is also required.

Preferred Qualifications:

  • QA experience supporting biologics, cell therapy, and/or gene therapy.
  • Specialized knowledge in industry-related niche topics such as bar coding, cell culture, auditing techniques, QC methods, and HEPA filtration science.
  • Previous experience interacting with regulatory agencies, representing technical deliverables as a subject matter expert, and audit hosting/support.
  • Experience with Contract Manufacturing Organization (CMO) oversight and compliance considerations.
  • ASQ certifications (e.g., certified quality engineer, quality auditor, quality professional) are advantageous.

Working Conditions:

This position is based in Massachusetts and will require on-site work. Hybrid work arrangements may be permitted in accordance with company guidelines.

Benefits:

  • 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 is dedicated to providing equal employment opportunities in all aspects of employment.

EOE including Disability/Protected Veterans

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