Manager Quality Assurance Disposition Support

Bristol Myers Squibb • Devens, MA

2d

About The Position

The Manager, Quality Assurance Disposition Support, Devens Cell Therapy role is responsible for the support of the overall Devens Disposition organization, inclusive of systems, metrics, Quality System Records, and deployment of priority projects. This individual will provide support to all functions reporting through the Quality Disposition organization, including incoming materials QA and disposition, systems, drug product disposition, and Material Review Board. This individual will provide oversight of projects with Disposition impact, APQR data compilation, Disposition metrics, CAPAs owned by Disposition, Deviations owned by Disposition, Change Control Impact Assessments, Change Controls owned by Disposition, product and will perform routine Material Review Board support. Work scope will include commercial manufacturing and clinical manufacturing for all cell therapy products manufactured in Devens. This role will interface with multiple departments including Supply Chain, Manufacturing, Quality Control, Quality Assurance, Project Management, Digital Plant, and Site Manufacturing Sciences & Technology

Requirements

• Bachelor's degree in STEM field preferred. High school diploma/ Associates degree with equivalent combination of education and work experience may be considered.
• 4-5 years of experience in a regulated industry with 1+ year quality experience.
• Demonstrated experience with electronic system and databases
• Ability to research, understand, intepret and apply internal policies and regulatory guidelines
• Proficient computer skills with knowledge of several digital tools like MS Office, Smartsheets etc. and ability to learn and work with new software applications
• Ability to interpret data & results, understand complex problems with multiple variables and critically assess and provide feedback on proposed solution and required documentation
• Ability to critically review investigation reports, interpret results and assess and challenge technical conclusions consistent with Quality risk management principles
• Excellent verbal and technical writing skills with ability to prepare written communications and present technical data to management with clarity and accuracy
• Ability to work in a fast-paced team environment and changing priorities
• Detail oriented and task focused with ability to meet deadlines and prioritize work
• Ability to think strategically , meet deadlines and prioritize work
• Able to work across functional groups and teams to ensure requirements are met
• Self motivated and contribute to a positive team environment
• Confident in making decisions for medium level issues and able to recognize Quality issues and solve problems
• Curious and ability to think critically to create innovative solutions

Nice To Haves

• Experience in FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing is preferred.

Responsibilities

• Support the overall Quality Disposition (QD) Organization by:
• Owning and driving Quality System records
• Performing product and change impact assessments
• Support the systems and data requests needed
• Maintain QD monitoring tools and metrics
• May represent the QD program in audits and inspections
• Performing routine Drug Product and Incoming Material disposition, as required, during peak and overflow periods
• Maintain inspection plans and SAP infrastructure for disposition operations
• Perform testing for eSystem changes as needed
• Other tasks as required by Quality Disposition leadership
• Support the Material Review Board (MRB) program by:
• Monitoring quality events and impact assessments, as needed, for potentially non conforming lots
• Sending Pre-MRB Notification to Mgt and MRB stakeholders along with scheduling MRB meetings and deliverables
• Collaborating with SMEs to obtain inputs and investigative information for MRB decision-making
• Attending MRB meetings and assisting in determination, with MRB, available treatment options for patients
• Managing confidential MRB documentation appropriately

Benefits

• Health Coverage: Medical, pharmacy, dental, and vision care.
• Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
• Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
• Work-life benefits include: Paid Time Off US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees) Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays Based on eligibility, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day. All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Number of Employees: 5,001-10,000 employees