Compliance Specialist

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 of 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 Compliance Specialist opportunity at their Astellas Institute of Regenerative Medicine (AIRM) site in Westborough, MA . This is a 2 nd shift onsite position. Work hours will be Monday-Friday 12:00 p.m. – 8:30 p.m. with occasional weekends.

Essential Job Responsibilities:

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

• Performs QA review of executed Manufacturing batch records, QC test records, raw material inspection records, and calibration records. Identifies and reports documentation errors and deviations from SOP or specifications in a timely manner. Tracks basic metrics on reviewed documents to support monthly reporting.

• Assists with the Deviation and Corrective / Preventive Action (CAPA) programs, aids investigations, and may assume investigation leader status for select deviation investigations. Helps ensure that deviation records are clearly written, technically sound, and provide thorough root cause analysis and risk assessment. May assist with monthly metrics and continuous improvement opportunities for these programs.

• May assist with the Internal Audit program for the organization, serving as an assistant auditor to help ensure all aspects of the GMP organization remain compliant with Astellas procedures and domestic / international GMP regulations.

• Actively participates in continuous improvement opportunities to identify efficiencies and compliance improvements to benefit department operations or the organization at large.

• Authors (or assists in authoring) new or revised standard operating procedures (SOPs) for the QA department to satisfy new compliance requirements or improve work practices.

• May assist senior QA staff in oversight of contract manufacturing organizations (CMO), monitoring information requests, reviewing CMO work, and following up on other compliance items.

Quantitative Dimensions:

• This position will provide a direct and positive impact on the compliance of the products, equipment, facility, methods, and systems supporting current and future AIRM manufacturing processes. AIRM processes will be compliant with the strictest international regulatory standards and meet Astellas’s uncompromising focus on Quality and Integrity.

Organizational Context:

• The Compliance Specialist reports to a Associate Quality Assurance Manager or Quality Assurance Manager, who in turn reports to the Director of Quality Assurance. Quality Assurance forms one element of the organization’s “Technical Operations” team, complementing and joined by Manufacturing, Quality Control, Engineering, Materials Management, Product Development, and Translational Development.

• Position is organized for a work schedule of second shift Monday – Friday 12:00 p.m. - 8:30 p.m. In very rare instances where QA coverage is needed on weekend days or evenings, these duties will rotate within the team and be negotiated with management in advance. GMP Operations at AIRM support cell culture manufacturing platforms, which naturally runs 7 days per week.

Required:

• BS/BA in Life Sciences, Engineering, or Chemistry, with 2-3 years of related Quality Assurance experience within GMP-regulated industry, or 1-2 years with Masters degree. In lieu of a Life Sciences degree, consideration will be given to candidates with minimum of 6 years of industry experience in biotechnological and/or pharmaceutical quality, manufacturing, or other industry requiring high technical aptitude and attention to detail.

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

Preferred:

• 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.

• Specialized knowledge of any 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.

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

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

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Category Development QA

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

EOE including Disability/Protected Veterans