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Bristol-Meyers Squibb, Co.

Manager, Compliance and Quality Systems

Pharmaceuticals

All

Full Time

On Site

No

Devens, Massachusetts, 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 Manager – Compliance and Quality Systems is responsible for providing QA oversight of Quality Management System (QMS) usage in support of GxP activities at Cell Therapy manufacturing sites. This work is performed in partnership with local manufacturing site users of the QMS, as well as global process owners for specific QMS processes.
    • Perform on-going review of sampling of completed records in the QMS relative to a pre-defined rubric/standard. Purpose of rubric review is to assess quality of records, specifically compliance to SOP requirements, audit readiness and identify areas of continued learning and continuous improvement for QMS users.
    • Identify trends and work with key stakeholders at sites and with Global Process Owners to improve performance of business relative to GMP expectations.
  • Additionally, the Manager is responsible for working within a team of cross-functional SMEs to respond to outcomes of rubric review and trending analysis. Responsible to develop communication to user community to address specific areas of opportunity and streamline efficient operations and reduce deviations. This includes:
    • Deviations: understand root causes of process or systemic defects with the QMS process and identify and implement robust solutions to prevent recurrence of observed deviations.
    • Proactive Initiatives/CAPAs: identify areas of risk and complete necessary change actions to mitigate or implementation of corrective and preventive actions to eliminate deviation recurrence.
    • Policies and Procedures: revise operational procedures to improve compliance and efficiency of operations.

REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities

  • Demonstrated knowledge of health authority requirements and industry guidance on Good Manufacturing Practices. Participation in health authority inspections or internal audits into QMS performance is preferred.
  • Demonstrated knowledge of quality risk management principles including, risk assessment, recommend controls and conduct periodic risk review. Six sigma or other problem-solving model experience is preferred.
  • Demonstrated ability to work within a cross-functional team is required to achieve improved performance is required. Experience with remote or distributed teams is preferred.
  • Demonstrated use of Project Management skills and milestone achievement
  • Demonstrated experience in auditing systems or processes.
  • Demonstrated application of sampling methods such as ANSI/ASQ Z1.4
  • Demonstrated proficiency in common computer tools such as word processing, spreadsheet and web based applications.
  • Experience in Quality Management System (QMS) such as Veeva, Trackwise, Documentum are preferred.
    • Ability to follow instructions, provided by Standard Operating Procedures (SOP) and test protocols and to document results clearly and in a timely manner following performance of tasks.
  • Ability to work as a member of team where combined contribution, collaboration, and time bound results are expected. Successful candidates must be able to provide and receive peer feedback in a positive fashion.

EDUCATION AND EXPERIENCE

  • Bachelor’s degree is required, with a preference for Engineering or Science.
  • Ideal candidate will have a minimum of 4 years of directly relevant experience with QMS usage. Experience in a regulated cGMP environment is required.

WORKING CONDITIONS: OFFICE & cGMP SPACES (US Only)

  • Work is performed in a typical office environment, with standard office equipment available and used. Work is generally performed seated but may require standing and walking for up to 10% of the time. Lighting and temperature are adequate and there are no abnormal conditions caused by noise, dust, etc.
  • 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 the resources to pursue their goals, both at work and in their personal lives.

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.

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 . Visit[Register to View] target="_blank"> [Register to View] 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.