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Director, Quality Systems and Compliance, Cell Therapy

Employer
Bristol Myers Squibb Company
Location
Devens, Massachusetts
Start date
Jan 30, 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.

At Bristol Myers Squibb we are reimagining the future of cell therapy. With our bold ambition, backed by a best-in-the-industry team and long-term commitment, we are leading the way to unlock the full promise of cell therapy as we strive to put more patients on the path to a cure. If you are ready to challenge yourself, accelerate your career, and give new hope to patients, theres no better place than here at BMS with our Cell Therapy team.

Our Quality Assurance and Compliance organization is pivotal in upholding quality standards within aseptic manufacturing, with core competencies in Microbiology and Chemistry. Our oversight extends across the entire product lifecycle, encompassing manufacturing, batch release, investigations, customer feedback management, document control, Quality Control testing, and diligent audits. Our team harnesses cutting-edge analytical and biologic test methods, leveraging state-of-the-art instrumentation and streamlined digital processes to meticulously affirm control.

We're currently seeking a Director of Quality Systems & Compliance at the Cell Therapy Facility (CTF) in Devens, MA. This role will be responsible for implementing and managing the site Quality Systems, Training and Document Control programs, identifying and assessing regulatory and quality risks during site GMP operations, and ensuring adherence to global regulations and BMS policies and procedures. This individual will be responsible for leading the CTFs continuous inspection readiness efforts and will be responsible for the CTF self-inspection program. This role will be responsible for leading the CTF Quality Council.

The Head of Quality Systems & Compliance will be a key member of the CTF Quality Leadership Team and a champion for quality principles and compliance within the Devens Cell Therapy organization. This role is stationed in Devens, MA and reports to the Executive Director of Quality for the Devens Cell Therapy Facility.

Key Responsibilities:

  • Hires, trains, and develops qualified Compliance & Quality Systems staff for the Devens Cell Therapy Facility.

  • Ensures that all Compliance & Quality Systems personnel have adequate training, education and experience to perform their GMP related job function effectively.

  • Directs quality oversight of compliance and quality systems activities including Quality Risk Management, Data Integrity, Training, Audits and Inspections, Document and Records Management and Site Quality Council.

  • Leads and facilitates Health Authority inspection approvals of the facility and products.

  • Leads the site inspection readiness program.

  • Leads the site self-inspection program to ensure that the site meets current regulatory and BMS corporate requirements.

  • Provides training programs for auditing and various GMP compliance topics.

  • Serves as a valued source of cGMP information to internal and external customers.

  • Manages responses and leads efforts for all CAPA/lessons learned from audits and inspections.

  • Provides leadership, guidance and problem solving skills.

  • Ensures that adequate documentation and records management quality system exists to support and drive compliance.

  • Ensures that all current vendors are qualified and conduct audits at defined frequencies as part of the vendor monitoring process.

  • Manages the Quality Council by sponsoring and driving Quality initiatives that directly impact the Site operations. Oversees all quality metrics tracking.

  • Manages and provides Quality Review of Annual Product Quality Review Report elements as established in products / systems schedule.

  • Creates, reviews, approves, and tracks corrective actions related to internal and external audits.

  • Ensures compliance with regulatory commitments.

  • Ensures compliance with applicable BMS Policies and Procedures and ensures consistency with other site procedures and/or specifications.

  • Reviews and approves procedures related to regulatory commitments.

  • Ensures that the procedures are properly followed and adequate for their use.

  • Verifies alignment with site procedures and to regulatory commitments.

  • Liaison for regulatory initiatives.

Qualifications and Experience:

  • BS/MS in relevant Science or Engineering discipline and 10+ years of experience in managing Quality Systems and Compliance or equivalent functions

  • Proven record with the successful implementation and management of the Quality System in a sterile, biologics or cell therapy commercial manufacturing facility

  • Expertise in GMP compliance, Quality System and global GMP regulations; must also have strong knowledge and experience with Quality Risk Management

  • Demonstrated Quality leadership through a cross-functional partnership to monitor key performance indicators and timely mitigate unfavorable quality compliance trends

  • Background in Biologics or Cell Therapy Manufacturing is preferred

  • Demonstrated experience building and leading exceptional Quality teams is required

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

  • 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 management team member and to engage and influence team members in a matrixed environment

#BMSCART

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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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