QA Deviation Reviewer, Approver Specialist

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:

This role will be responsible for providing quality oversight for site manufacturing operations and quality control laboratory operations at the Summit S12 Cell Therapy manufacturing facility, in accordance with Bristol Myers Squibb policies, standards, procedures and Global cGMP. Functional responsibilities for the incumbent include ensuring accurate and timely maintenance and review of procedures and methods; providing compliance oversight for Manufacturing Operations and QC laboratories; ensure accurate and timely review of manufacturing and laboratory investigations; and identifying any trends.

REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:

• Must have knowledge and experience with cGMP manufacturing, Quality, and Compliance.
• Directs quality initiatives that accomplish continuous improvement and enhance site manufacturing efficiencies, while providing a safe and compliant process.
• Must have strong authorship and be able to critically review investigations, interpret results and generate technical conclusions.
• Must be able to note technical/scientific attributes in potential situations or issues and process science-based solutions across most of the job function.
• Must be action-oriented and customer-focused, building relationships, problem solving, planning and organizing, resource allocation, and analytical thinking.
• Must possess an independent mindset and tenacity.
• Work is self-directed.
• Routinely recognizes Quality issues and solves problems.
• Follows established procedures and performs work as assigned.
• Ability to interpret results and situations and articulate recommendations for resolution.
• Capable of providing input within the department and cross functional teams.
• Builds relationships internally within and with cross functional teams.
• Contributes to goals within the work group.
• Able to prepare written communications and communicate problems to management with clarity and accuracy.
• Able to write and review reports with clarity and brevity.
• Thorough knowledge of and competence in quality processes, including but not limited to material disposition, deviations, investigations, and CAPA management.
• Able to effectively multi-task.
• Knowledge of US and global cGMP requirements.
• Understanding of aseptic manufacturing processes.
• Teamwork and ability to work effectively across functional groups and teams to ensure requirements are met.
• Excellent verbal and written communication skills.

Education and Experience:

B.S. degree required; minimum of 3 of experience in the pharmaceutical or related industry.

DUTIES AND RESPONSIBILITIES:

• Supports all activities for the Quality Operations group.
• Provide quality oversight of Manufacturing Operations, QC Chemistry and QC Microbiology.
• Work with manufacturing and laboratory management to ensure activities comply with global regulatory requirements.
• Ensure procedures are adequate to review and confirm appropriateness of raw data.
• Review and approve manufacturing and QC laboratory investigations, interpret results and generate technical conclusions consistent with Quality risk management principles.
  • Ensure appropriate CAPAs are generated to increase compliance and prevent repeat occurrences of deviations.

• Establishes and maintains procedures to ensure data integrity is maintained and procedures/processes are compliant.
  • Assess global standards/policies and emerging regulations.
• Ensure the site stability program meets global and regulatory requirements.
• Must be skilled in planning and organizing, decision-making, and building relationships.
• Able to effectively multi-task.

WORKING CONDITIONS (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.

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 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.