Manager, Site Support - Devens, MA

Job Description

ATTENTION MILITARY AFFILIATED JOB SEEKERS - 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 click the submit button and follow the next steps.

Unless specifically stated otherwise, this role is "On-Site" at the location detailed in the job post.

Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it.

You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.

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.

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. Assure the quality of manufactured products are in compliance with all applicable regulations and guidelines. May assist in preparing for and hosting of 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 and provides 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. Tracks and reviews deliverables for disposition and re-evaluation
• Supports and provides quality oversight to projects and incoming transfers for cell banking operations
• Provides quality oversight, review and approve Master Data for SAP and Syncade in support of tech transfer and projects
• Provides 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 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 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…