Astellas Pharma Compliance Specialist in Westborough, Massachusetts
The Astellas Institute of Regenerative Medicine (AIRM) is a wholly-owned subsidiary of Astellas Pharma 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.
Developing innovative therapies is one of the most challenging, most essential and personally rewarding fields in science. This is the most exciting time to be a part of Astellas, a company with a uniquely collaborative and patient-focused culture. There's something special about working at Astellas. It's reflected in our focus on the people we serve, the way we treat each other and the results we achieve together as a company.
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 Marlborough, Massachusetts.
Astellas is announcing a Compliance Specialist opportunity at their Astellas Institute of Regenerative Medicine (AIRM) site in Westborough, MA.
This member of the Quality Assurance team will perform 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:
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.
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.
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 normal work schedule of Monday -- Friday, day shift. 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 run 7 days per week.
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).
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.)
Category Quality Assurance/Quality Control
Astellas is committed to equality of opportunity in all aspects of employment. EOE including Disability/Protected Veterans