Associate Director, Quality Assurance 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 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: careers.bms.com/working-with-us

Purpose and Scope:

The Associate Director is responsible for the Quality oversight of manufacturing operations at the Bothell, WA Cell Therapy manufacturing site. This person will be a key leader in the Quality Assurance Operations management team and a champion for quality principles and compliance within the Quality organization.

Knowledge, Skills, and Abilities:

Education:

• BS in relevant Science or Engineering discipline.

Experience:

• 9+ years of experience in managing Quality Assurance function.
• 5 years of people management experience.
• Expertise in GMP compliance.
• Experience with oversight of GMP operations.
• Background in Pharma, Biotech, or Cell Therapy Manufacturing is desired.
• Experience in building and leading exceptional team.
• Demonstrated excellence in written and verbal communication.
• Demonstrated ability to work cross-functionally and to develop and maintain strong business partner relationships.
• Proven leadership ability to carry out difficult decisions in a logical, rational manner, and demonstrated ability to work as a Quality leader engaging and influencing team members in a matrixed environment.

Job Responsibilities:

• Responsible for the Quality Assurance oversight of GMP operations at the Bothell Manufacturing site and ensuring adherence to applicable GMP regulations and BMS policies and procedures.
• Provide direction and ensure timely guidance to Quality Operations personnel during handling and resolution of GMP events (deviations and corrective action assessments).
• Work with SME experts to develop a comprehensive understanding of the manufacturing processes for BMS products and the associated risk management control strategy to identify process risks and associated critical controls.
• Ensure timely Quality support to site compliance activities such as Change Control impact assessments, during deviation investigations, and CAPA development.
• Collaborate with leaders across the organization in continuous improvement and efforts to drive business strategy and site compliance.
• Support the BMS Inspection readiness plan at the Bothell Manufacturing site.
• Develop departmental goals and ensure the timely completion of all deliverables, including batch record review and approval.
• Act as a subject matter expert for QA oversight of GMP operations during audits and regulatory inspections.
• Champion and foster a positive and successful quality culture, aligned with BMS’s existing culture.
• Mentor Quality personnel and enable their individual growth.

The starting compensation for this job is a range from $149,000 – $188,000, plus incentive cash and stock opportunities (based on eligibility). The starting pay takes into account characteristics of the job, such as required skills and where the job is performed. Final, individual compensation is decided based on demonstrated experience. For more on benefits, please visit our BMS Careers site. Eligibility for specific benefits listed in our careers site may vary based on the job and location.

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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
Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.

COVID-19 Information
To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.

BMS is dedicated to ensuring that people with disabilities can perform complex functions through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an accommodation prior to accepting a job offer. If you require reasonable accommodation 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 will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

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