Job Details
Supervisor, Quality Assurance
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 will be responsible for leading a team during their shift, who are involved in the daily activities of manufacturing, assessing and releasing drug products at the BMS manufacturing site (JUMP) located in Bothell. The primary focus of the QA Supervisor will be to provide quality oversight of GMP operations and ensure compliance with all relevant quality standards and regulations throughout the product lifecycle, from product receipt to release.
The QA Supervisor has a strong understanding of GMP (Good Manufacturing Practices), SOPs (Standard Operating Procedures), and regulatory requirements, as well as proven experience in quality assurance in a pharmaceutical manufacturing environment. QA Supervisor should have excellent communication and interpersonal skills, be a strong leader and able to work collaboratively with cross-functional teams to achieve common goals.
This is for a Sunday - Wednesday, 1:30pm-Midnight shift
Education:
Preference will be given to candidates who hold a Bachelor's degree in a related field. However, a minimum of an Associate's degree or an equivalent combination of education and experience is required
Experience
5-7 years of relevant cGMP experience. Experience in FDA/EMA regulation in the biotechnology and/or cellular therapy field is preferred.
Demonstrate 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.
Demonstrate excellent communication and interpersonal skills, be a strong leader and able to work collaboratively with cross-functional teams to achieve common goals.
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. Participates in cross functional project teams, provides QA support to technical transfers in conjunction with relevant teams/ individuals.
- Ensures deviations, CAPA, change controls, process transfers, and other business drivers are supported in a compliant manner.
- Support and serve as SME for investigations and risk assessment activities
- 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 Team when appropriate.
- 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 BMS’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.
- Demonstrate excellent communication and follow-through with leadership and external stakeholders, ensure department KPIs are met, and communicate real-time feedback to the team
- Support global network harmonization (e.g. aseptic practices, integration projects, and other network standardization project)
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 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, #veteran, #LI-Onsite, #NIGHT_SHIFT_QUALITY
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.
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.
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.
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.