Supervisor, Quality Assurance Compliance

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!

Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com .

Astellas Institute for Regenerative Medicine (AIRM) is a wholly owned subsidiary of Astellas Pharma Inc and focused on the development and commercialization of stem cell and regenerative medicine therapies. Astellas is an R&D-driven global pharmaceutical company whose philosophy is to contribute to the improvement of people's heath around the world through the provision of innovative and reliable pharmaceutical products.

AIRM has a world-class R&D team, and is pursuing a diverse range of disease indications, ranging from macular degeneration (currently in clinical trials) and other ocular indications to vascular and autoimmune disease. AIRM's intellectual property portfolio includes pluripotent stem cell platforms -- both embryonic and induced pluripotent stem cells as well as other cell-based therapy research programs. AIRM is headquartered in Massachusetts.

Astellas is announcing a Supervisor, Quality Assurance Compliance opportunity at their Astellas Institute for Regenerative Medicine (AIRM) site in Westborough, MA.

Purpose:

The Supervisor, Quality Assurance Compliance role oversees and performs critical QA compliance tasks in support of GMP manufacturing programs as AIRM moves through clinical trials and commercialization. The successful candidate will foster compliance across a broad range of Quality Assurance areas and will work closely with talented counterparts in the Manufacturing, Quality Control, and Materials Management teams to help ensure high quality standards and value delivery for our patients.

Essential Job Responsibilities:

Essential Duties and Responsibilities include, but are not limited to, the following:

• Manages and grows the QA Compliance team responsible for QA review of executed Manufacturing batch records, QC test records, raw material inspection records, and calibration records.

• Collaborates with cross-functional stakeholders regarding quality events (e.g., deviations, Corrective / Preventative Actions (CAPAs), etc.), assisting in investigations and ensuring quality records are clearly written, technically sound, and provide thorough root cause analysis and risk assessment.

• Serves as a resource fluent in GMP Self-Inspection / Internal Audits for the organization, ensuring all steps of the GMP organization remain compliant with Astellas procedures and domestic / international GMP regulations.

• Oversees contract manufacturing organizations (CMOs), monitoring information requests, reviewing CMO work, and following up on compliance-related items.

• Develops compliant Quality processes and procedures to satisfy new compliance requirements and leads improvement of existing work practices.

• Participates in strategic initiatives related to new projects and initiatives, as needed.

• Aggregates monthly metrics, identifying, planning, and executing continuous improvement opportunities for process efficiencies and compliance improvements to benefit department operations and / or the organization at large.

• Ensures cGMP compliance through direct oversight and education of subordinate team members.

• Provides coaching, mentoring, professional development, and performance management to junior Quality Assurance staff, as appropriate.

Qualifications Required:

• BS/BA, or equivalent, in Life Sciences, Engineering, or Chemistry with 7+ years of related Quality Assurance experience within GMP-regulated industry, or 5+ years with Master's degree. In lieu of a Life Sciences, or equivalent, degree, consideration will be given to candidates with minimum of 10+ years of industry experience in biotechnological and/or pharmaceutical quality, manufacturing, or other industry requiring high technical aptitude and attention to detail.

• Previous experience in a Supervisory or Lead position.

• Demonstrated knowledge of cGMPs for biotechnology. Working understanding of ICH Q7, Q8, Q9, Q10, and other international regulatory requirements.

• Ability to interpret regulatory rules, guidance, and normative industry standards to make objective, risk-based decisions, and exercise sound Quality-by-Design principles. Experience presenting these outcomes to management.

• Fluency in Deviation investigation techniques, root cause analysis methods, CAPA effectiveness verification, and product impact assessments.

• Working fluency in the Microsoft Office productivity suite (including Excel and PowerPoint).

Preferred:

• QA experience supporting biologics, cell therapy, and/or gene therapy.

• Specialized knowledge of industry-related niche topics: bar coding, cell culture, auditing techniques, QC methods, HEPA filtration science, etc.

• Previous experience interacting with regulatory agencies, representing technical deliverables as a subject matter expert, audit hosting / support, etc.

• Experience with Contract Manufacturing Organization (CMO) oversight and compliance considerations.

• ASQ certifications (e.g., certified quality engineer, quality auditor, quality professional, etc.)

Working Conditions:

• This position is based in Westborough, MA and will require on-site work. Hybrid work from certain locations may be permitted in accordance with Astellas’ Responsible Flexibility Guidelines.

Benefits:

• Medical, Dental and Vision Insurance

• Generous Paid Time Off options, including Vacation, Sick time, plus national holidays including Heritage Days, and Summer and Winter Breaks

• 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

Category BioPharma QA

Astellas is committed to equality of opportunity in all aspects of employment.

EOE including Disability/Protected Veterans