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Job Details


Bristol Myers Squibb

Supervisor, Quality Assurance Operations

Technology

Quality Assurance

No

Bothell, Washington, United States

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 OF POSITION:

The Quality Assurance (QA) Supervisor is responsible for leading a team that provides QA oversight of GMP operations including batch record review production and associated cGMP records to assure product quality is consistent with established standards and in compliance with regulatory and industry standards for the Bothell Manufacturing Plant (Jump).

In addition, the Supervisor will be responsible for the people on shift involved in the day-to-day Quality Assurance Operations associated with the production of both clinical and commercial autologous cell therapy products. This person will be a key leader responsible for GMP operations and meeting critical business goals.

Shift: Sunday - Wednesday, 1330 - 0000

REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:

Education:

  • Minimum of Bachelor’s degree and/or equivalent combination of education and experience is required.

Experience

  • 5-8 years of relevant cGMP experience. Experience in FDA/EMA regulation in the biotechnology and/or cellular therapy field is preferred.

  • Demonstrated proficiency in selection of team and effectively managing personnel issues is highly desired. Proven ability to demonstrate attention to detail, personal and team accountability where it is critical to success.

  • Minimum of 2 years leadership experience including the management of direct reports is preferred.

DUTIES AND RESPONSIBILITIES:

  • Using the production schedule, develops and manages a daily plan for a work team of Quality Assurance Operations associates.

  • Leads/ supports deviation process, investigations, and closure of records, CAPA (Corrective and Preventative Action), change controls, process transfers, and other business drivers are supported in a compliant manner.

  • Participates in cross functional project teams, provides QA support to technical transfers in conjunction with relevant teams/ individuals.

  • Ensures QA reviews and approves documents, including standard operating procedures, batch records, material specifications, and validation protocols and reports.

  • Interviews, hires, coaches, motivates, and develops exceptional staff. Sets performance objectives and development plans. Monitors performance progress conducts annual performance reviews for all direct reports and recommends advancements for Quality Assurance Operations On-The-Floor Team when appropriate. Ensures team goals are met.

  • Champions a culture of exceptional teamwork, communication, and continuous improvement within the QA Operations team and across the organization.

  • Ensures a culture that embraces the safety of the work environment and the safety of the patients by compliance with company procedures and policies, and cGMP requirements.

  • Identifies and mitigates risks in production, quality and supporting operations that could negatively impact the safety, identity, strength purity or quality of the product.

  • Assists in the design, implementation and continuous improvement of Quality Assurance systems that are technically sound, promote effective and efficient operations, and comply with cGMP requirements.

  • Provides leadership support during trouble shooting of equipment, operation, and processes as it relates to ensuring the quality and compliance of the product.

  • Provides Quality input during the optimization of the use of raw materials, equipment, and personnel in producing compliant products and leads/participates in continuous improvement initiatives as part of Jump’s commitment to operational excellence.

  • Assists in the development and communication of team policies, organizational structure, shift structure, and career ladders. Ensures adherence to all policies and regulations.

  • Actively pursues learning of required skills and new skills.

  • Must exercise accurate judgment and be able to evaluate information critically and decide upon appropriate course of action. Must be able to correlate events and determine the action plan required to avoid incidents recurrence and apply them.

  • Proven commitment to quality and continuous improvement.

  • Possesses excellent compliance understanding. This includes both technical and regulatory requirements pertaining to equipment function and application. Understands biotechnology processing, the purpose of unit operations, clean room design and behavior, and microbial control concepts, including aseptic technique. Possesses ability to couple a technical process understanding with a strong regulatory and compliance understanding to ensure that operations are conducted in an efficient, and compliant manner to deliver safe and effective therapies to our patients.

WORKING CONDITIONS (US Only):

  • While performing the duties of this job, the employee is frequently required to stand; walk; sit; bend; stretch; use hands and fingers, with various manipulations; reach with hands and arms; and effectively communicate with others in the workplace, including the ability to make and promptly respond to audible cues and warnings.

  • May work in areas that may have strong magnets.

  • May work in areas with exposure to vapor phase liquid nitrogen and other chemicals.

  • Must be able to gown per requirements to enter manufacturing space.

  • Will be required to wear personal protective equipment (PPE) and other clean room garments daily. This may include, but not limited to safety shoes, safety glasses, aprons, face shields, lab coats, full body gowns, hairnets, gloves, and hearing protection.

This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.

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.

The starting compensation for this job is a range from $75,000 - $95,000, 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.

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.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.