Manager Quality Systems, Investigations and CAPA

Bristol Myers Squibb • Devens, MA

48d • $115,110 - $139,500 • Onsite

About The Position

The Manager, Quality Systems is responsible for supporting the ownership and oversight of Devens Cell Therapy quality systems, such as CAPA, Investigations per established local and global standards. This position supports the overall compliance and performance of Devens Cell Therapy Quality Systems Management as it applies to the site level, including periodic assessments of process performance and continuous improvement opportunities

Requirements

• Ability to research, understand, interpret, and apply internal policies and regulatory guidelines
• Proficient computer skills with knowledge of several digital tools like MS Office, etc., and ability to learn and work with new software applications
• Ability to interpret data & results, understand complex problems with multiple variables and critically assess and provide feedback on impact assessments and proposed change control actions
• Ability to critically review reports, interpret results and assess and challenge technical conclusions consistent with quality risk management principles
• Excellent verbal and technical writing skills with ability to prepare written communications and present technical data to management with clarity and accuracy
• Ability to work in a fast-paced team environment and changing priorities
• Detail oriented and task focused with ability to meet deadlines and prioritize work
• Able to independently work across and influence cross-functional groups to ensure requirements are met
• Ability to motivate and foster a positive team environment
• Confident in making decisions for complex issues and able to recognize Quality issues and solve problems
• Curious and ability to think critically to create innovative solutions
• Bachelor's degree in STEM field preferred. High school diploma/ Associates degree with equivalent combination of education and work experience may be considered.
• 6+ years of experience in a regulated industry, preferably with 2+ year of quality system experience. Experience in FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing is preferred.
• Demonstrated proficiency with electronic system and databases

Responsibilities

• Review and approve complex site quality system deliverables and risk assessments associated with all aspects of manufacturing process including incoming, manufacturing, laboratory, facility, and utility systems.
• Ensure quality system deliverables are robust and adequately address requirements and risks, by providing oversight and rubric reviews, as applicable.
• Support the administration and maintenance of quality systems such as CAPA, Investigations, including metrics reporting and analysis, stakeholder communication, and governance meeting facilitation, as needed.
• Share data/ knowledge within and across site and network. Build & maintain strong relationships with partner functions.
• Lead meetings and represent function at cross functional and network meetings.
• Identify improvement opportunities and drive team continuous improvement goals and projects.
• Support internal and external inspections.
• May act as subject matter expert and present quality system program overviews and related topics during audits.
• Maintain compliance with assigned learning plan.
• Support integration of newer team members and provide guidance and coaching to users of the electronic QMS, CAPA, and Investigations quality systems, as required.
• Lead meetings and represent function at cross functional meetings. Share data/ knowledge within and across teams. Build & maintain strong relationships with partner functions.

Benefits

• Medical, pharmacy, dental and vision care.
• Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP).
• Financial well-being resources and a 401(K).
• Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support.
• Work-life programs include paid national holidays and optional holidays, Global Shutdown days between Christmas and New Year's holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility.
• Parental, caregiver, bereavement, and military leave.
• Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources.
• Other perks like tuition reimbursement and a recognition program.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Chemical Manufacturing
• Number of Employees: 5,001-10,000 employees