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Job Details


Bristol Myers Squibb

Quality Lead for Sterile Products Facility Expansion (Phoenix)

Technology

Lead Developer

No

Phoenix, Arizona, United States

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: careers.bms.com/working-with-us

Required Competencies:

  • BA Science Degree or related required, Master's preferred.

  • 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

#LI-Onsite

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 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.