Quality Systems Manager - Change Control & Risk

Nashoba Valley Chamber of Commerce; Harvard (MA); On-site; USD 107,000 - 130,000; Full time

Benefits offered by this job

Health Coverage

Wellbeing & EAP programs

401(k) plan

Paid Time Off

Job summary

Bristol Myers Squibb seeks a Manager to lead Change Control and Quality Risk Management for the Devens Cell Therapy site. You will oversee Change Control governance, drive improvements using data, and ensure alignment with global standards and health authority regulations.

The role requires deep knowledge of quality systems, risk management, and cross-functional collaboration to advance site performance and compliance.

Qualifications

• Bachelor's degree in STEM; higher education preferred.
• 6+ years in a regulated industry, with 2+ years quality system experience.
• Experience with Change Control and Risk Management; familiarity with FDA/EMA regulations in biopharma or cell therapy is preferred.

Responsibilities

• Support oversight of the site Change Control system and Change Control Review Board.
• Drive governance maturity plans to improve site performance via data-based analysis.
• Maintain site Change Control system in line with local/global standards and health authority regulations.
• Coordinate with Technical Review Board, IT change management, QA Technical Services to drive solutions.
• Lead problem solving to deliver compliance-focused actions and manage cross-functional stakeholders.
• Act as site SME on quality systems, SOPs, and training documents.

Skills

Tech Transfer

Computer System Validation

Change Control

Quality Risk Management

Risk Management Tools

Data analysis

MS Office

Education

Bachelor's degree in STEM

6+ years regulated industry experience

Quality system experience

Tools

MS Office

Job description

Bristol Myers Squibb seeks a Manager to lead Change Control and Quality Risk Management for the Devens Cell Therapy site. You will oversee Change Control governance, drive improvements using data, and ensure alignment with global standards and health authority regulations.

The role requires deep knowledge of quality systems, risk management, and cross-functional collaboration to advance site performance and compliance.