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Job Details


Bristol Myers Squibb

Supervisor, Manufacturing Compliance

Manufacturing and Production

Manufacturing Supervisor

No

Bothell, Washington, United States

At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

PURPOSE AND SCOPE OF POSITION:

The Manufacturing Compliance Supervisor leads a team of individual contributors that manage manufacturing projects and quality commitments. The manufacturing compliance team is a part of the overall manufacturing team and is organized around quality deliverable work product such as deviation investigation trend assessments, CAPA, batch records, training, and change controls. The Manufacturing Compliance Supervisor is responsible for managing all aspects of the manufacturing compliance team including people (individual contributors), written procedures, business processes, and key performance indicators. They are also responsible for maintaining a culture of compliance and innovation. Additionally, the Manufacturing Compliance Supervisor serves as a mentor to members of the manufacturing compliance or operations team, sponsors complex projects, and helps develop future state business processes for manufacturing.

REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities

Education

Associate’s or Bachelor’s degree in related field is preferred. Minimum of high school diploma and/or equivalent combination of education and experience is required.

Experience

  • 4+ years of experience in a GMP Quality or Manufacturing setting.
  • Prefer minimum of 2 years leadership experience, including management of direct reports.
  • Demonstrated proficiency in building and leading teams.
  • Extensive knowledge of SOPs and cGMPs and the know–how to work and manage within a regulatory environment.
  • Demonstrates aptitude for engineering principles and manufacturing systems.
  • Adaptable to a fast paced, complex, and ever-changing business environment.

DUTIES AND RESPONSIBILITIES:

  • Hiring, mentoring, and developing exceptional individual contributors.
  • Leading the development vision and decision-making alignment across team within manufacturing.
  • Working with team to deliver quality commitments on time, in full.
  • Creating and enhancing a culture of teamwork, collaboration, and communication across the manufacturing organization
  • Building effective cross-functional relationships both internally within the Manufacturing Leadership Team and externally across Jump.
  • Championing the Jump quality philosophy.
  • Ensures daily work coordination and distribution as needed.
  • Establishing individual, team, and department goals; tracking and reporting KPIs; and driving continuous improvement efforts.
  • Identifying and mitigating risks in manufacturing operations that could negatively impact delivery of safe and effective therapies to patients.
  • Championing inspection readiness efforts and providing Inspection support as required.
  • Aiding in establishing team policies, organizational structure, shift structure, and career ladders.
  • Build partnerships with cross functional department teams.
  • Provide critical communications upward, downward, and across as deemed fit; manage decisions– acquire feedback, input, and consult as required.
  • Reviewing and approving documents, including standard operating procedures, batch records, material specifications, and validation protocols / reports.
  • Ensuring deviations, CAPA, change controls, process transfers, and other business drivers are supported.
  • Driving right first time (RFT) culture within Manufacturing.
  • Ensuring projects, change controls, process transfers and other business drivers are collectively supported.
  • Ensuring communications delivered to all staff member levels are accurate, consistent, and fit to vision within the functional area.

Working Conditions (US Only)

  • Typing and computer use for extended periods
  • Must be able to sit/ stand for extended periods of time.
  • Temperature controlled, well lighted environment
  • Minimal work in areas that may have strong magnets.
  • Minimal work in areas where handling human blood products (Biosafety Level 2) may be required.
  • Must be able to occasionally work in a cleanroom environment that requires gowning.

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

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.

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

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.

Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

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