Manager, QA Manufacturing Operations

Manager, QA Manufacturing Operations

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.

Shift Friday, Saturday, and Sunday 12-hour shift 7am to 7pm

Key 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.
• Defines and enforces performance measures, provides developmental feedback and coaching and creates a collaborative environment enhances unit performance and integration across site departments.
• Hires, integrates, and develops high-quality talent, capable of delivering against the department's goals and objectives.
• Provides quality oversight of manufacturing activities on a day-to-day basis and provides oversight of the review and approval of minor changes to master batch recipe records.
• Performs review and approval of Quality, Manufacturing, and Material Specification SOPs and documents.
• Provides oversight to Quality walkthroughs for shutdown and inspections readiness activities and ensures program management is in compliance with site and corporate procedures.
• Contributes to and supports the site team which prepares for, hosts, and responds to regulatory inspections.
• Reviews, approves, and provides guidance for quality master data. Responsibilities include updates to Drug Substance lot status in applicable quality systems.
• Directly participates in internal audits or reviews as well as global health authority inspections. May include representation on inspection response and CAPA teams.
• May provide Quality review and approval of investigation records and CAPA, records.
• Provides for strategic foresight to identify and implement changes to enhance long-term goals of the department and drive continuous improvement.
• May act as delegate for QA Operations Manager for departmental meetings, projects, and tasks.
• Supervises up to 6 employees overseeing quality floor support of manufacturing

• Key core behavioral indicators for this role include participation in the creation of a team-based environment, promoting candor, collaboration, receptivity, clarity of purpose and goals, and high commitment to achieve business goals.
• Demonstrates appropriate examples of compliance behaviors and attitudes.

Qualifications & Experience

• Specialist: 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.
• Decision-making where commitment is required on release dates for product and/or material.
• Works to resolve problem that may arise when a product or material needs to be released in a short time frame and documents received are incomplete and/or contain errors.
• Demonstrates initiative to clarify unclear situation in the presence of documentation irregularities.
• Prioritizes when handling multiple work assignments and deadlines. Provides clear direction and priorities.
• Works with a minimum of supervision.
• QA Manager acts as authorized delegate in the absence of the Quality Operations Senior Manager.
• Travel Required (nature and frequency): Travel may be required for this position and is anticipated to be approximately 10% of the time.

This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management.

If you come across a role that intrigues you but does not perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Compensation Overview: Devens - MA - US: $100,480 - $121,756

The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee's work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience.

Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit careers.bms.com/life-at-bms/.

Benefit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following: 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.

Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as "Transforming patients' lives through science™, " every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion, and integrity bring out the highest potential of each of our colleagues.

On-site Protocol BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based, and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role: Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles, the ability to physically travel to visit customers, patients, or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments, and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

If you live in or expect to work from Los Angeles County if hired