Senior Specialist, Quality Assurance Shop Floor, Cell Therapy
Bristol Myers Squibb
6 months ago
On-site
Devens, MA
Operations
Position Summary
- Oversees and partners with operational areas to ensure compliance with Bristol-Myers Squibb policies, standards, procedures, and Global cGMP.
- Provides 24x7 Quality collaboration and oversight of site operations, including Manufacturing, Quality Control laboratories, and Warehouse Operations.
- Reports to the Shift Manager, Quality Assurance Shop Floor.
- Rotating 2-3-2 Panama schedule (6am to 6pm) Day shift.
Key Responsibilities
- Provide Quality on-the-floor oversight to Manufacturing/QC/Warehouse/Packout; identify departures from approved procedures, respond to complex issues independently, and escalate critical issues.
- Perform and document operational verification per approved procedures.
- Develop, review, and/or approve temporary and non-routine procedures for event response.
- Observe manufacturing operations to identify departures from clean room behaviors and aseptic techniques.
- Provide quality oversight to non-routine maintenance; review and approve return to service plans.
- Coordinate and lead area walkthroughs to identify quality issues; negotiate remediations and drive alignment of implementation plans.
- Own shift actions for departmental programs and propose improvements.
- Participate in Gemba walks.
- Review manufacturing/testing records for compliance; communicate and resolve discrepancies and escalate as required.
- Author, review, and approve procedural documents.
- Maintain compliance with assigned learning plan; provide guidance/training for QA personnel (may own training curriculum/content).
- May present individual topics during audits.
- Independently assess discrepancies for entry into the quality system and approve deviations as applicable.
- Serve as quality subject matter expert for risk assessments, change controls, etc.
- Lead meetings and represent the function at cross-functional meetings.
- Share data/knowledge; build and maintain relationships with partner functions.
- May prioritize and assign tasks for the team.
Qualifications
Specific Knowledge, Skills, Abilities
- Ability to research, understand, interpret, and apply internal policies and regulatory guidelines.
- Proficient computer skills (e.g., MS Office) and ability to learn new software.
- Ability to interpret data/results, solve complex problems with multiple variables, and articulate practical solutions.
- Excellent written/verbal skills; ability to present technical data to target audiences.
- Ability to work in a fast-paced team environment and lead peers through changing priorities.
- Detail-oriented and task-focused; ability to meet deadlines and support prioritization.
- Ability to negotiate and influence for mutually beneficial solutions.
- Ability to motivate and foster a positive team environment.
- Strong decision-making; think creatively while maintaining compliance and quality.
- Pioneering mindset and ability to create innovative solutions.
Education/Experience/Licenses/Certifications
- Bachelor’s degree in a STEM field preferred; high school diploma/Associate degree with equivalent education and work experience may be considered.
- 4+ years of relevant cGMP experience; preferably 1+ year of manufacturing site experience.
- Experience with FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing preferred.
- Demonstrated experience with quality management systems.
- Demonstrated experience with electronic systems/databases such as MES and ERP.
Benefits (explicitly listed)
- Health coverage: medical, pharmacy, dental, vision.
- Wellbeing support: BMS Well-Being Account, BMS Living Life Better, Employee Assistance Programs (EAP).
- Financial wellbeing/protection: 401(k), short- and long-term disability, life and accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, survivor support.
- Paid Time Off (as described for US Exempt or other groups).
Application Instructions
- Apply if the role interests you even if your experience does not perfectly align (encouraged to apply anyway).
- Oversees and partners with operational areas to ensure compliance with Bristol-Myers Squibb policies, standards, procedures, and Global cGMP.
- Provides 24x7 Quality collaboration and oversight of site operations, including Manufacturing, Quality Control laboratories, and Warehouse Operations.
- Reports to the Shift Manager, Quality Assurance Shop Floor.
- Rotating 2-3-2 Panama schedule (6am to 6pm) Day shift.
Key Responsibilities
- Provide Quality on-the-floor oversight to Manufacturing/QC/Warehouse/Packout; identify departures from approved procedures, respond to complex issues independently, and escalate critical issues.
- Perform and document operational verification per approved procedures.
- Develop, review, and/or approve temporary and non-routine procedures for event response.
- Observe manufacturing operations to identify departures from clean room behaviors and aseptic techniques.
- Provide quality oversight to non-routine maintenance; review and approve return to service plans.
- Coordinate and lead area walkthroughs to identify quality issues; negotiate remediations and drive alignment of implementation plans.
- Own shift actions for departmental programs and propose improvements.
- Participate in Gemba walks.
- Review manufacturing/testing records for compliance; communicate and resolve discrepancies and escalate as required.
- Author, review, and approve procedural documents.
- Maintain compliance with assigned learning plan; provide guidance/training for QA personnel (may own training curriculum/content).
- May present individual topics during audits.
- Independently assess discrepancies for entry into the quality system and approve deviations as applicable.
- Serve as quality subject matter expert for risk assessments, change controls, etc.
- Lead meetings and represent the function at cross-functional meetings.
- Share data/knowledge; build and maintain relationships with partner functions.
- May prioritize and assign tasks for the team.
Qualifications
Specific Knowledge, Skills, Abilities
- Ability to research, understand, interpret, and apply internal policies and regulatory guidelines.
- Proficient computer skills (e.g., MS Office) and ability to learn new software.
- Ability to interpret data/results, solve complex problems with multiple variables, and articulate practical solutions.
- Excellent written/verbal skills; ability to present technical data to target audiences.
- Ability to work in a fast-paced team environment and lead peers through changing priorities.
- Detail-oriented and task-focused; ability to meet deadlines and support prioritization.
- Ability to negotiate and influence for mutually beneficial solutions.
- Ability to motivate and foster a positive team environment.
- Strong decision-making; think creatively while maintaining compliance and quality.
- Pioneering mindset and ability to create innovative solutions.
Education/Experience/Licenses/Certifications
- Bachelor’s degree in a STEM field preferred; high school diploma/Associate degree with equivalent education and work experience may be considered.
- 4+ years of relevant cGMP experience; preferably 1+ year of manufacturing site experience.
- Experience with FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing preferred.
- Demonstrated experience with quality management systems.
- Demonstrated experience with electronic systems/databases such as MES and ERP.
Benefits (explicitly listed)
- Health coverage: medical, pharmacy, dental, vision.
- Wellbeing support: BMS Well-Being Account, BMS Living Life Better, Employee Assistance Programs (EAP).
- Financial wellbeing/protection: 401(k), short- and long-term disability, life and accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, survivor support.
- Paid Time Off (as described for US Exempt or other groups).
Application Instructions
- Apply if the role interests you even if your experience does not perfectly align (encouraged to apply anyway).