What are the responsibilities and job description for the Investigations and CAPA Lead position at Astellas?
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 an Investigations and CAPA Lead opportunity at their Astellas Institute for Regenerative Medicine (AIRM) site in Westborough, MA.
Purpose:
The Investigations and CAPA Lead will be responsible for overseeing and managing all aspects of the investigation and Corrective and Preventative Action (CAPA) processes in support of GMP manufacturing as the Astellas Institute of Regenerative Medicine (AIRM) moves through clinical trials and commercialization. This role’s primary responsibility is ensuring nonconformances and CAPAs are investigated thoroughly and appropriately. The CAPA plans are implemented, monitored, and closed in compliance with internal and regulatory requirements. The Investigations and CAPA Lead will work closely with cross-functional teams to ensure continuous improvement, effective risk mitigation strategies, and help ensure high quality standards and value delivery for our patients.
This position requires flexibility in working hours to support patient production runs, which may occur outside of the typical 9:00 – 5:00 PM schedule and may include weekends.
Essential Job Responsibilities:
Essential Duties and Responsibilities include, but are not limited to, the following:
Lead Investigations: Oversee and manage the investigation process for nonconformances and CAPAs, ensuring investigations are conducted promptly, thoroughly, and in compliance with internal and regulatory requirements.
CAPA Management: Develop, implement, and oversee CAPA plans to address root cause of identified issues, ensuring CAPA effectiveness, timely completion, and progress tracking to ensure sustainable process improvements.
Cross-Functional Collaboration: Work closely with internal stakeholders to ensure alignment on investigations and CAPA effectiveness.
Training & Mentorship: Provide training and mentorship to junior staff and cross-functional stakeholders related to nonconformances and CAPAs to promote a culture of quality and compliance throughout the organization.
Trending and Reporting: Review investigation and CAPA data to identify trends and proactively propose improvements or corrective actions. Prepare and present monthly metrics on the status of nonconformances and CAPAs to quality management and relevant AIRM and global stakeholders.
Risk Management: Identify and assess potential risks related to nonconformances and CAPAs, recommending mitigation strategies to minimize impact on product quality and compliance.
Continuous Improvement: Proactively seek opportunities for improving investigation processes, CAPA systems, and the overall quality system through innovation and best practices.
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.
QA experience supporting biologics, cell therapy, and/or gene therapy.
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 outcomes to management and other stakeholders.
Fluency in nonconformance investigation techniques, root cause analysis methods, CAPA effectiveness verification, and product impact assessment.
Proficiency in electronic quality management systems (TrackWise preferred).
Working fluency in the Microsoft Office productivity suite (including Excel and PowerPoint).
Excellent analytical, problem-solving, and critical thinking skills.
Strong interpersonal and communication skills.
Detail-oriented, with a focus on compliance and continuous improvement.
Preferred:
ASQ certifications (e.g., certified quality engineer, quality auditor, quality professional, etc.)
Leadership experience is a plus.
Experience with global regulatory requirements and interactions with regulatory agencies.
Experience in risk management practices related to CAPA and nonconformance.
Working Conditions:
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
