Manager, QA Manufacturing Operations

Bristol-Myers Squibb • Devens, MA

100d • $100,480 - $121,756 • Hybrid

About The Position

Working with Us 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.

Requirements

• A M.S. with 4-6 years of relevant experience within the pharmaceutical or healthcare industry, or a B.S. with 7-9 years of relevant experience within the pharmaceutical or healthcare industry; including 2-4 years experience in a regulated function.
• Experience in a R&D environment is an asset.
• Strong knowledge of pharmaceutical processing techniques.
• In-depth knowledge of GMP regulations.
• Strong interpersonal and organizational skills.
• Demonstrated leadership skills.
• Computer literacy: Microsoft Office and SAP environment, Quality management system, Veeva, PDLIMS, and other systems as required (e.g. DeltaV, PilotClean).
• Decision-making regarding disposition for distribution of clinical trial materials and materials for production, based on documentation review.
• Ability to work with a minimum of supervision.

Responsibilities

• Establish and communicate performance objectives for Quality Assurance staff that are consistent with the business' unit goals, Quality and Technical Operations objectives.
• Provide quality floor support of complex manufacturing issues.
• Define and enforce performance measures, provide developmental feedback and coaching, and create a collaborative environment that enhances unit performance and integration across site departments.
• Hire, integrate, and develop high quality talent, capable of delivering against the department's goals and objectives.
• Provide quality oversight of manufacturing activities on a day-to-day basis and oversee the review and approval of minor changes to master batch recipe records.
• Perform review and approval of Quality, Manufacturing, and Material Specification SOPs and documents.
• Provide oversight to Quality walkthroughs for shutdown and inspections readiness activities and ensure program management is in compliance with site and corporate procedures.
• Contribute to and support the site team which prepares for, hosts and responds to regulatory inspections, reviews and approvals of the facility and products.
• Review, approve and provide guidance for quality master data, including updates to Drug Substance lot status in applicable quality systems.
• Directly participate in internal audits or reviews as well as global health authority inspections.
• Provide Quality review and approval of investigation records and CAPA records.
• Provide strategic foresight to identify and implement changes to enhance long term goals of the department and drive continuous improvement.
• Act as delegate for QA Operations Manager for departmental meetings, projects and tasks.
• Supervise up to 6 employees overseeing quality floor support of manufacturing.

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 including 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.
• Tuition reimbursement and a recognition program.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Industry: Chemical Manufacturing
• Education Level: Master's degree