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.

Job Title: Head of Quality Cell Therapy Bothell WA Facility, Executive Director

Manager: Vice President, CTDO Quality

Department/Group: Quality

Travel Required: 5%

Location: Bothell, WA

Job Description

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.

Job Summary

BMS is seeking a Head of Quality at the BMS Cell Therapy Manufacturing Facility in Bothell WA. This role will be responsible for leading the day-to-day Quality operations at the Bothell 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 in preparation for commercialization of BMSs 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 Bothell Cell Therapy Facility organization. This individual will be a member of the Bothell Manufacturing Leadership Team. This role is stationed in Bothell WA and reports to the Vice President, Cell Therapy Quality.
Job Responsibilities

* Responsible for the Quality oversight of GMP operations at the Bothell 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, 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, MS&T, to ensure readiness for commercialization at the Bothell facility
* Lead the management review of quality compliance and operational KPIs at the Bothell manufacturing facility; ensure timely mitigation of unfavorable trends
* Lead the implementation of BMSs Pre-license inspection readiness plan at the Bothell facility
* Provide expertise and guidance in interpreting governmental regulations, agency guidelines and internal procedures to assure continued compliance at the Bothell 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 Bothell Cell Therapy Quality annual operating budget
* Represent and lead Bothell Cell Therapy Quality in the development of corporate initiatives, harmonization initiatives and planning

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
* 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

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.