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Manager, QA Sterility Assurance
1 week ago
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 rich in diversity. 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. Read more:
The Manager for the QA Sterility Assurance group is an individual contributor responsible for quality oversight of the site contamination control strategy, including Environmental Monitoring (EM). This position reports to the Associate Director of Quality Assurance Sterility Assurance at Cell Therapy Manufacturing: Bothell.
Responsibilities/Duties:
• Quality oversight and support for contamination control programs such as environmental monitoring, cleaning and disinfection, gowning, access and flow, facility modifications, qualifications, disruptions, and shutdowns.
• Quality oversight and support for Microbiology QC Testing Methods. Review and approve associated document revisions, protocols, reports, testing plans,
• Review and approve investigations/ CAPAs / effectiveness checks associated with the manufacturing site including but not limited to environmental monitoring excursions (EME), aseptic personnel qualification (APQ), aseptic operations, cleanrooms, utilities, and Microbiology laboratory.
• Quality Oversight and Management of Environmental Monitoring Trending Program. Author or Review and approve EM and Utility trending reports at designated frequencies (i.e., quarterly, and annually).
• Review and approve qualification lifecycle documentation associated with manufacturing cleanrooms, water and gas utilities, including but not limited to environmental monitoring process qualification (EMPQ), aseptic process simulation (APS), airflow visualization (AVS), cleanroom reclassification (CRC),
• Creation and Revision of technical documents (SOPs, Risk Assessments, Reports, Protocols, etc.). Quality Approvals of documents created by others.
• Quality oversight and approvals for disruptions and shutdowns to the cleanroom environment.
• Facilitate and/or approve quality risk assessments and technical reports associated with the contamination control strategy (CCS), including but not limited to disinfectant efficacy testing (DET), drug product process and facility microbial risk assessments.
• Review and approve or provide impact assessment for site change controls. Author impact assessments for complex level site change controls and EMPQ assessments.
• Support the Contamination Control Strategy, Quality Initiatives, and Identify continuous improvement opportunities. Support execution of site/team improvement goals and projects related to environmental and contamination control programs. Perform associated quality approvals as required.
• Routinely recognize and resolve Quality issues; propose solutions for complex issues and work with management to resolve.
• Support internal and external inspections as required. Participate in the preparation and execution of corrective and preventative actions related to inspection findings. Perform associated quality approvals as required.
• Maintain compliance with assigned learning plan. Support development of training content.
• Act as Subject Matter Expert and provide guidance/ coaching to less experienced staff with atypical microbial events.
• Lead meetings and represent function at cross functional and network meetings. Share data/ knowledge within team, and across site and network.
• Ability to collaborate with cross-functional team members on projects related to contamination control program. Build and maintain strong relationships with partner departments.
• Perform other tasks as assigned.
Specific Knowledge, Skills, Abilities:
• Excellent verbal and technical writing skills with advanced ability to prepare written communications and present complex technical data to management with clarity and accuracy.
• Ability to research, understand, interpret, and apply internal policies and regulatory guidelines.
• Demonstrated experience with interpreting complex data, results, and problems with multiple variables and critically assess and provide feedback on proposed solution and required documentation.
• Demonstrated experience to critically review investigation reports, interpret results, and assess and challenge technical conclusions consistent with Quality risk management principles.
• Ability to work in a fast-paced team environment and lead peers through changing priorities.
• Ability to think strategically, meet deadlines and support work prioritization.
• Able to independently work across functional groups and teams to ensure requirements are met.
• Self-motivated and ability to motivate and foster a positive team environment.
• Confident in making decisions, able to anticipate Quality issues and proactively solve problems.
• Curious with ability to think critically to create innovative solutions.
• Proficient computer skills with knowledge of several digital tools like MS Office, etc., and ability to learn and work with new software applications.
Education/Experience/ Licenses/Certifications:
• Bachelor's Degree in Microbiology, Biology, STEM, or related science.
• 6+ years of relevant cGMP experience or equivalent combination of education and experience in a regulated industry, preferably with 2+ years of Contamination Control and Quality assurance experience.
• Experience in Quality Control or Quality Assurance function in a cGMP manufacturing operation. Experience with Aseptic Processes and Practices, Contamination Control, Risk Management, and Quality Systems.
• Experience in FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing.
• Demonstrated ability to collaborate and lead cross-functionally to develop and maintain strong business partner relationships.
• Demonstrated experience with electronic systems and databases.
• Demonstrated experience with root cause analysis and risk management tools such as 5-WHY, Human Error Prevention, Fishbone Analysis, FMEA, PrHA, etc.
• Demonstrated experience with electronic document and validation documentation systems.
The starting compensation for this job is a range from $92,000 to $121,000, plus incentive cash and stock opportunities (based on eligibility).
The starting pay rate takes into account characteristics of the job, such as required skills and where the job is performed.
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 our BMS Careers Site.
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.
BMSCART
If you come across a role that intrigues you but doesn't 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.
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 an inclusive culture, promoting diversity 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 a diverse 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 Visit 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 for this position, please visit this page for important additional information:
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
