Quality Assurance Investigations Manager

4 weeks ago


Devens, Massachusetts, United States Bristol-Myers Squibb Full time

**Transforming Patients' Lives through Science**

Bristol Myers Squibb is a leading biopharmaceutical company that is dedicated to transforming patients' lives through science. We are seeking a highly skilled and experienced Quality Assurance Investigations Manager to join our team at our Cell Therapy Facility in Devens, MA.

**Key Responsibilities**

As a Quality Assurance Investigations Manager, you will be responsible for leading the quality review and approval of manufacturing and laboratory investigations and product complaints. You will provide quality oversight and ensure that manufactured products are in compliance with all applicable regulations and guidelines.

**Responsibilities Include:**

* Leading root cause analysis and determining appropriate corrective/preventative actions

* Maintaining and reviewing SOPs

* Acting as a Subject Matter Expert in quality investigations and product complaints

* Assisting in preparing for and hosting regulatory and customer audits

**Requirements**

* B.S. in a life or physical science related discipline (equivalent industry experience will also be considered)

* Minimum of 6 years of pharmaceutical experience or related GMP industry

* Knowledge and experience with cGMP manufacturing, quality, and compliance as well as US and global cGMP requirements

* Excellent verbal and written communication skills

* Demonstrated ability to develop and maintain strong business partner relationships internally and with cross-functional teams

**What We Offer**

Bristol Myers Squibb offers a competitive benefits package, including medical, dental, and vision insurance, 401(k) matching, and paid time off. We also offer opportunities for professional growth and development, as well as a collaborative and inclusive work environment.

**If you are a motivated and experienced professional looking for a new challenge, we encourage you to apply for this exciting opportunity.**



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