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Senior Manager, Manufacturing Compliance & Training

Company: Bristol-Myers Squibb
Location: Bothell
Posted on: March 19, 2023

Job Description:

Senior Manager, Manufacturing Compliance & Training page is loaded Senior Manager, Manufacturing Compliance & Training Apply locations Bothell - WA - US time type Full time posted on Posted 2 Days Ago job requisition id R1567537 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: PURPOSE AND SCOPE OF POSITION: The Manufacturing Compliance Senior Manager leads a team of 30 managers, supervisors, and individual contributors that manage manufacturing 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 trending, CAPA execution (Corrective Action/ Preventative Action), training, technical transfer activities, Quality Risk Management documents, Master Batch Record content, and change control records. The Senior Manager is responsible for managing all aspects of the Manufacturing Compliance & Training team, including the people, written procedures, business processes, and key performance indicators. Additionally, the Senior Manager serves as a mentor to members of the manufacturing compliance or operations team, sponsors complex projects or teams, and helps develop future state business processes for manufacturing. REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:Education:

  • Bachelor's degree in relevant science or engineering discipline and/or equivalent combination of work experience is required.Experience:
    • 12+ years of relevant cell therapy or other regulated industry manufacturing experience.
    • Minimum of 6 years of leadership experience including the supervision of direct reports. Minimum of 3 years in a Quality Assurance role.Knowledge, Skills, and Abilities
      • Proven proficiency in coaching and developing front line leaders is required.
      • Extensive knowledge of SOPs and cGMPs and the know-how to work and manage within a regulatory environment.
      • Adaptable to a fast paced, complex and ever-changing business environment.DUTIES AND RESPONSIBILITIES:Key ResponsibilitiesManage the Manufacturing Compliance & Training Team at Jump. This includes:
        • Hiring, mentoring and developing exceptional individual contributors and front line leaders.
        • Leading the development vision and decision-making alignment across teams groups within manufacturing.
        • Working through a 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.Participates in operation of the Jump Manufacturing Plant. This includes:
          • Deploying department goals, tracking and reporting KPIs, and driving continuous improvement efforts within the reporting group
          • Identifying and mitigating risks in manufacturing operations that could negatively impact delivery of safe and effective therapies to patients, eg - via performing Gemba walks, trending programs, risk evaluations
          • Coordinating inspection readiness efforts within Manufacturing
          • Establishing team policies, organizational structure, shift structure, and career ladders
          • Assigning review of and training for a variety of 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 with Compliance resources
          • Driving right first time (RFT) culture and executes manufacturing unit operations by providing direct training, guidance, and problem solving
          • Aiding in establishment of policies, organizational structure and career ladders.
          • Delivering communications to staff member levels that are accurate, consistent, and fit to vision within the functional area supervisory group The starting compensation for this job is a range from $114,000 - $144,000, 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 decid ed based on demonstrated experience. For more on benefits, please visit our BMS Careers si te. Eligibility for specific benefits listed in our careers site may vary based on the job and location. WORKING CONDITIONS (US Only):
            • Office environment: temperature-controlled, LED or Fluorescent lighting
            • Typing and computer use for extended periods
            • Sit/stand workstations available
            • 8-hour standard work week (5 days x 8 hours)
            • May work some days remotely, up to 2 days/work weekThis 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. BMSCART VETERAN 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 . Visit 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. About Us Data Privacy Link W e're creatinginnovative medicines for patients fighting serious diseases. We're also nurturing our own diverse team with inspiring work and challenging career options. No matter the role, each one of us makes a contribution. And that makes all the difference.

Keywords: Bristol-Myers Squibb, Seattle , Senior Manager, Manufacturing Compliance & Training, Executive , Bothell, Washington

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