Executive Director Quality Cell Therapy Manufacturing Facility

Profile

Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

BMS is seeking a Head of Quality at the Cell Therapy Manufacturing Facility in Devens MA. This role will be 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 BMS' quality systems in preparation for commercialization of BMS' Cell Therapy products. This includes but not limited tothe 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 Manufacturing 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, Global Cell Therapy Quality.

Job Responsibilities

Responsible for the Quality oversight of GMP operations at the Devens Cell Therapy manufacturing 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

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

Provide Quality oversight of facility design, build and qualification.

Work collaboratively with Leads from Facilities and Engineering, Manufacturing, IT, Patient Operations, MSAT, to ensure the timely facility qualification and readiness for commercialization at the Devens facility

Lead the management review of quality compliance and operational KPIs at the Devens manufacturing facility; ensure timely mitigation of unfavorable trends

Lead the implementation of BMS' Pre-license inspection readiness plan at the Devens facility

Provide expertise and guidance in interpreting governmental regulations, agency guidelines and internal procedures to assure continued compliance at the Devens 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 the Devens Cell Therapy Quality in the development, planning and execution of corporate initiatives

Qualifications and Education Requirements

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

Expertise in GMP compliance and global regulations

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 providing quality oversight of facility design, build and qualification

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

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

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 the resources to pursue their goals, both at work and in their personal lives.

Company: Bristol-Myers Squibb

Req Number: R1520574_EN

Updated: 2020-05-07 00:00:00.000 UTC

Location: Devens,Massachusetts

Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.

Company info

Bristol-Myers Squibb Company
Website : http://www.bms.com