Manager, QA Manufacturing Operations

Overview

Working with Us Challenging. Meaningful. Life-changing. Bristol Myers Squibb offers unique opportunities to grow and contribute across departments, from production optimization to breakthroughs in cell therapy. You’ll have chances to advance alongside high-achieving teams and grow your career.

Bristol Myers Squibb recognizes balance and flexibility in our work environment. We offer competitive benefits, services and programs to support employees in pursuing goals at work and in personal life. Read more:

Support Devens site through review and approval of investigations and change controls. Provide Quality oversight and support for Technology Transfer, Automation, Cell Bank Disposition, Validation, Manufacturing Science and Technology, Master Data and Site Engineering programs. Ensure manufactured products are in compliance with applicable regulations and guidelines. May assist in preparing for and hosting regulatory audits.

• Supports and provides quality oversight to technical transfer sub-teams and the review and approval of technology transfer documentation
• Leads and provides quality oversight to automation forums. Provide review and approval of automation change management.
• Assures consistent, effective use of the site change control system for all change requests. Ensures supporting documentation and change deliverables meet external regulatory and internal Global BMS guidelines and requirements.
• Leads the cell bank disposition program and program management. Track and review deliverables for disposition and re-evaluation.
• Support and provides quality oversight to projects and incoming transfers for cell banking operations.
• Provide quality oversight, review and approve Master Data for SAP and Syncade in support of tech transfer and projects.
• Provide quality oversight, review and approve Maximo work orders, OOTs, extensions for PMs and Cals.
• May support projects interfacing with Site Engineering.
• Provides quality support and oversight for Manufacturing Science and Technology and Validation protocols and reports and periodic assessments.
• Provides quality support to Devens Site through quality review and approval of deviations or change controls.
• Participates as requested in the response team for audits and inspections by world health authorities.
• Receives little supervision and identifies and reports discrepancies from normal practices or procedures to management, recommending and implementing corrective actions.
• Makes sound decisions by exercising judgment within generally defined practices and policies and notifies management as appropriate.
• Drives opportunities for continuous improvement through project leadership, quality systems program ownership, and group engagement.
• Represents QA in cross-functional meetings.
• Provides training on QA-owned procedures.
• May provide guidance to less experienced staff.
• May have direct supervision of non-exempt and/or exempt staff.

• Knowledge of biotech bulk and finished product manufacturing, analytical testing is highly desirable.
• Extensive knowledge of US and EU cGMP regulations and guidance.
• Knowledge of Quality Risk Management principles preferred.
• Knowledge of electronic systems including SAP, LIMS, Infinity (Veeva Vault), LES, Maximo, Vault and Syncade desirable.
• Experience working in a team-based environment with a diverse group of people.
• Excellent writing and oral communication skills are required.

• Knowledge of science generally attained through studies resulting in a B.S. in science, engineering, biochemistry or related discipline, or its equivalent is preferred.
• A minimum of 6 years of relevant experience in a regulated environment with at least 4 years focused on product quality.

• Quality Operations – Site Support personnel may interact with any employee at Devens Facility across Quality staff, Site Engineering, Operational Engineering, Supply Chain, Automation, Technical Services and Manufacturing staff for change management and deviations.
• There may be contact with outside vendors and representatives from health authorities/regulatory agencies.