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Executive Director, Site Quality Head (Devens)

Employer
Bristol Myers Squibb Company
Location
Devens, Massachusetts
Start date
Jan 31, 2024

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Job Details

Working with Us
Challenging. Meaningful. Life-changing. Those arent 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. Youll 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.

The Head of Quality at the Devens Cell Therapy Manufacturing Facility is responsible for leading the day-to-day Quality operations at the Devens Cell Therapy site including Quality Assurance Operations, Quality Systems and Compliance, and Quality Control. The role will also be a key contributor to the implementation and execution of BMSs quality systems for Cell Therapy products. This includes but not limited to the implementation of policies, practices, procedures, standards, and systems necessary to ensure the compliance of site operations to global GMP regulations.

This individual will be a key leader in the Global Cell Therapy Quality organization and a champion for quality principles and compliance within the Devens Cell Therapy Facility organization. This individual will be a member of the Devens Cell Therapy Leadership Team in addition to the Global Cell Therapy Quality Leadership Team. This role is stationed in Devens, MA and reports to the Vice President, Internal Manufacturing Sites Quality for Cell Therapy.

Major Responsibilities Include:

  • Responsible for the Quality oversight of GMP operations at the Devens Cell Therapy Facility and ensuring adherence to applicable GMP regulations and BMS policies and procedures

  • Assure the required processes, procedures, systems, and resources are in place to ensure a compliant disposition of materials and cell therapy products

  • Collaborate with other leaders across the organization and assist in the continuous improvement and lifecycle management of GMP policies and quality management system, including providing guidance and direction for transitioning from clinical to commercial phase GMP operations

  • Provide leadership and build an exceptional team to manage the Quality functions (Quality Assurance, Quality Systems, Quality Control), including hiring, mentoring, and developing personnel

  • Work collaboratively with Leads from Facilities and Engineering, Manufacturing, IT, Patient Operations, and MS&T, to ensure the timely facility qualification and readiness for commercialization at the Devens Cell Therapy Facility

  • Lead the management review of quality compliance and operational KPIs at the Devens Cell Therapy Facility; ensure timely mitigation of unfavorable trends

  • Lead the implementation of BMSs Pre-license inspection readiness plan at the Devens Cell Therapy Facility

  • Provide expertise and guidance in interpreting governmental regulations, agency guidelines and internal procedures to assure continued compliance at the Devens Cell Therapy Facility

  • Lead and host compliance audits and regulatory inspections by competent regulatory authority (e.g., FDA, EMEA, MHRA, etc.)

  • Develop departmental goals and ensure timely completion of all deliverables

  • Champion and foster a positive and quality compliance culture

  • Establish and effectively manage the Devens Cell Therapy Quality annual operating budget

  • Represent and lead Devens Cell Therapy Quality in the development of corporate initiatives and planning

Education and Experience Requirements:

  • BS/MS in relevant Science or Engineering discipline and 15+ years of experience in managing Quality functions

  • Experience in hosting global regulatory agency inspections and successfully presenting product and quality compliance programs to regulatory agency reviewers is required

  • Experience with implementing and overseeing GMP operations in a commercial manufacturing facility is required

  • Experience in continuous improvement, operational excellence and six-sigma is desired

  • Expertise in GMP compliance and global regulations

  • Demonstrated Quality leadership through a partnership approach with manufacturing to enable high quality and compliant product distribution to patients is required

  • Background in Biologics or Cell Therapy Manufacturing is required

  • Demonstrated experience building and leading exceptional Quality Assurance, Quality Systems and Quality Control teams is required

  • Demonstrated excellence in written and verbal communication

  • Demonstrated ability to work cross-functionally and to develop and maintain strong business partner relationships

  • Proven leadership ability to carry out difficult decisions in a logical, rational manner, and demonstrated ability to work as a senior management team member and to engage and influence team members in a matrixed environment

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-HYBRID

If you come across a role that intrigues you but doesnt 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.

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments 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 cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

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.

Company

Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.

At Bristol Myers Squibb, we believe in the power of science to address some of the most challenging diseases of our time. Our focus on these unmet needs comes during a remarkable time, when unprecedented scientific breakthroughs are advancing the treatment of disease as never before in human history.

We work every day to transform patients’ lives through science. Each day, our employees around the world work together for patients – they are at the center of everything we do. They inspire us. They are the reason we come to work each day.

We combine the agility of a biotech with the reach and resources of an established pharmaceutical company to create a global leading biopharma company powered by talented individuals who drive scientific innovation.

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Company info
Website
Phone
+1-800-332-2056
Location
430 E. 29th St
14th Floor
New York
New York
10016
United States

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