Job Description

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.

The BMS manufacturing site of Phoenix is a network facility for Aseptic Manufacturing of Sterile Injectable Drug Products. Our Senior Director, Quality Lead for Sterile Products Facility Expansion is part of the sterile product expansion team at the Phoenix site. This role is accountable for the Quality oversight and leadership of all activities related to the expansion of the Phoenix site for new product introductions (NPI).  Activities include the full scope equipment and facility installation/qualification, process transfer/validation, methods transfer/validation, regulatory submission, regulatory approval inspection readiness, and post approval commercial introduction of new products.   

The position is responsible for driving and coordinating all quality aspects related to the introduction and transfer of new and existing sterile products to the Phoenix site from within and outside of the BMS network.

The core mission is to guarantee all of the quality aspects are efficiently managed within the NPI ensuring compliant and robust compliance to BMS Policies, Standard Operating Procedures, and regulations.   

This position is primarily located at the BMS site in Phoenix.

Required Competencies:  Knowledge, Skills, and Abilities

• Combination of 12+ years Quality Assurance and/or Quality Control experience in pharmaceutical or biotech industry

• 8+ years within Quality Assurance in a leadership position managing teams and/or projects

• Facility build and start-up experience, including construction, commissioning, and qualification through regulatory approval

• Sterile process manufacturing experience (5+ years) preferred with expert knowledge of equipment and operations

• Thorough understanding of GMPs, and EMA and FDA regulatory requirements.

• Demonstrated experience in Regulatory strategies and tactics.

• Solid project management and negotiation skills with ability to drive results.

• Strong leader with demonstrated ability to build relationships and foster team cohesion.

• Excellent written, communication skills, and organizational skills.

Duties and Responsibilities

• Serve as the Quality Lead for coordination and oversite of all Quality functions (i.e QA, QC, compliance, and systems) for the Phoenix Expansion Program by leading all of the quality aspects.

• Responsible for ensuring on time and compliant quality support of project timelines.

• Responsible for the compliant transfer across site to site operations.

• Manage the quality aspects’ coordination with internal/external stakeholders such as development, AS&T, MS&T, PMO, manufacturing.

• Responsible for alignment between internal manufacturing sites.

• Liaise with site quality leadership to assure support for all quality activities.

• Participate actively in inspections / audits for site inspection readiness.        

• Effectively utilize internal expertise when making decisions

• Communicate regularly with Quality Leadership across the BMS network to facilitate project support and escalate information as necessary.

BMSBL, VETERAN

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.

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