Manager, QA Technical Operations - Devens MA

Job Opportunity For Military Affiliated Candidates

Our organization works with partner companies to source qualified talent for their open roles. The following position is available to Veterans, Transitioning Military, National Guard and Reserve Members, Military Spouses, Wounded Warriors, and their Caregivers. If you have the required skill set, education requirements, and experience, please follow the next steps.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.

Major Duties and Responsibilities:

• 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 and 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 applies appropriate notification to 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 and Skill:

• 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 any of the following: 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.