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Job Details


Bristol Myers Squibb

Senior Manager, Quality Assurance Shop Floor

Technology

Quality Assurance

No

Warren, New Jersey, 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:

Senior Manager, Quality Assurance Shop Floor is responsible for leading day-to-day QA on-the-floor operations at the Warren, NJ site in accordance with BMS Cell Therapy Operations (CTO) policies, standards and procedures. Provides management of activities including but not limited to APH/CAPH receipt, review and maintenance of drug product pack-out batch records and clinical drug product labeling, Quality “on-the-floor” support to manufacturing operations, and review and approval of site specific procedures. This role is responsible for leading the QA Shop Floor team, establishing processes, procedures and training.

DUTIES AND RESPONSIBILITIES:

  • Oversees Shop Floor group located at the Warren, NJ facility. Assures job objectives are met on a timely basis.
  • Assures product quality and compliance by enforcing quality assurance policies and procedures; ensures the required processes, procedures, systems and resources are in place.
  • Builds and manages an effective QA on-the-floor program.
  • Builds a strong QA Shop Floor team and provide mentorship and development of personnel.
  • Oversees review of manufacturing shop floor documentation, real time review of master batch records, issuance of drug product and shipping labels and pack-out.
  • Participates and drives Quality Risk Management (QRM) initiatives at the site to ensure risk areas are identified and risk control measures are implemented.
  • Updates and procures approval of job descriptions for department personnel. Performs and oversees the training of personnel. Effectively hires, develops, counsels, manages and motivates staff. Writes and administers performance appraisals for department personnel.
  • Assures standard operating procedures (SOPs) related to job responsibilities define the steps necessary to complete tasks, etc. Writes, reviews and updates SOPs.
  • Creates and maintains effective training program for QA on the floor program.
  • Maintains current knowledge of industry standards as it applies to cGMPs and global regulatory guidelines and requirements.
  • Performs supplemental investigations/projects as required by senior management.

Display Leadership Qualities

  • Creates an environment of teamwork, open communication, and a sense of urgency.
  • Promotes a mindset of continuous improvement, problem solving, and prevention.
  • Builds trust and effective relationships with peers and stakeholders.
  • Drives improvements to remove inefficiencies, improve quality and optimize productivity.
  • Develops and authors training and other documents to educate and to improve consistency, quality, and efficiency in performing routine activities.

REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:

  • Minimum of 8+ years working in a Quality or Manufacturing role (or combination thereof) within a commercial biopharmaceutical, cellular therapy, or gene therapy organization.
  • Detail oriented with strong knowledge of cGMP regulations, FDA, EMA and PMDA guidelines applicable to biologics and cell therapy.
  • Must be able to interpret problems and effectively prepare surrounding communication in a productive manner to management and the group with clarity, brevity, and accuracy.
  • Must be skilled in planning and organizing, conflict management, coaching others, talent selection, developing others, decision-making, building relationships, innovation management, and resource allocation.
  • Leads teams and cross-functional project teams and drives team performance and results. Contributes to departmental performance and quality initiatives; able to conceptualize impact of Quality initiatives in terms of cross-functional teams; emerging as a leader contributing to BMS culture and values.
  • Requires minimal direction to complete tasks, knows how to get resources and information from established internal contacts; consults with supervisor for decisions outside established processes; manages experienced professional employees; authority to make daily decisions that impact their team.
  • Routinely recognizes and resolves Quality issues; informs management of proposed solutions. Seeks management guidance on complex issues; develops procedures.
  • Able to interpret complex results and situations with degree of independence and articulate recommendations for solutions. Recognizes risk and develops contingency plans. Negotiates solutions cross-functionally. Drives continuous improvement and improves efficiency and productivity within the group or project.
  • Scope of problem solving includes direct reports. Critically assesses project(s) and allocates resources to efficiently achieve goals. Implements solutions independently. Develops employees.
  • Effectively communicates internally within the function and with internal and external cross-functional teams. Interacts with internal and external cross-functional teams. Represents department in internal and external cross-functional teams.
  • Manages conflict and issues with internal and external customers. Demonstrates negotiation skills in internal and external cross-functional teams. Demonstrates coaching skills.
  • Independently resolve complex issues with minimal direction from management.
  • Work is self- directed.

EDUCATION AND EXPERIENCE (As Applicable):

  • BS degree required.
  • Minimum 8 years relevant work experience and minimum 5 year of leadership experience.
  • Equivalent combination of education and experience acceptable.

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.

#LI-Onsite

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.