Senior Manager, QC Analytics (Cell Therapy) – Hybrid

Regulatory Jobs; Harvard (MA); Hybrid; USD 125,000 - 151,000; Full time

Benefits offered by this job

Flexible Time Off

11 paid holidays

Wellbeing support and comprehensive福利

Job summary

Bristol Myers Squibb seeks a Senior Manager, QC Analytical at the Cell Therapy Facility in Devens, MA. The role leads QC operations, drives performance KPIs, and partners with cross-functional teams to sustain GMP compliance and continuous improvement.

The position is hybrid with 50% onsite work, offering significant leadership responsibility, budgetary oversight, and opportunities to shape QC programs across the network.

Qualifications

• Bachelor's degree or equivalent; advanced degree preferred.
• 10+ years of relevant lab work experience, preferably in regulated environment.
• 4+ years of management and people leadership experience.
• Experience with bioanalytical techniques (cell-based assays, ELISA, qPCR, flow cytometry).
• Experience with LIMS, ELN, data analysis systems and ERP systems (SAP).
• Ability to operate in a highly regulated GMP environment and ensure data integrity.

Responsibilities

• Lead and oversee the QC Analytical lab, ensuring testing and data review for in-process, release, and stability testing.
• Foster a culture of teamwork, safety, quality, and operational excellence.
• Develop, track, and report KPIs for QC Analytical performance; drive continuous improvements.
• Own one or more QC programs and lead the team to deploy and maintain the program.
• Hire, mentor, and develop team members; provide feedback and coaching.
• Approve test methods, procedures, and documents ensuring regulatory alignment.

Skills

Leadership

Bioanalytical techniques

Regulatory GMP

Communication

Lean Six Sigma

Data analysis

Excel

Education

Bachelor's degree

10+ years experience

4+ years management

Tools

LIMS

ELN

DeltaV

SAP

Job description

Bristol Myers Squibb seeks a Senior Manager, QC Analytical at the Cell Therapy Facility in Devens, MA. The role leads QC operations, drives performance KPIs, and partners with cross-functional teams to sustain GMP compliance and continuous improvement.

The position is hybrid with 50% onsite work, offering significant leadership responsibility, budgetary oversight, and opportunities to shape QC programs across the network.