Associate Director, Principal Product Quality Lead

Location
Seattle, WA, United States
Posted
Sep 22, 2020
Ref
R1527577
Required Education
Bachelors Degree
Position Type
Full time
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.

About Bristol-Myers Squibb

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.

Position Summary

We are seeking a Principal Product Quality Lead (Principal PQL), Associate Director of Global Product Quality. The Principal PQL will partner with the Global Product Quality Lead (GPQL) to provide direct technical and quality compliance oversight of a late-stage cell therapy vector program. The Principal PQL will be assigned oversight and decision authority over multiple aspects of the cell therapy vector program as it moves through commercialization readiness activities including commercial filing and approvals as well as life-cycle management activities. They will assist the Global PQL to develop and roll-out global product quality strategies relating to end-to-end Quality management of clinical / commercial manufacturing, life-cycle improvements (process, analytical), analytical control strategies (methods, specifications), stability, product complaints, and monthly Product Quality Team reviews. They will support implementation and risk mitigation strategies related to technology transfer, comparability, clinical filings, and life-cycle improvements (as needed). They will also be expected to collaborate with QC, QA, Manufacturing, Stability, Analytical Development, Process Development, Manufacturing Sciences and Technologies, Regulatory Affairs, and other Cell Therapy Development Organizations to ensure regulatory compliance of GMP operations in support of the vector program. This role is stationed in Summit, NJ or Seattle WA and reports to the Director, Global Product Quality, Cell Therapy Vector Programs.

Detailed Position Responsibilities

• Provide global product quality oversight and support for external manufacturing / partnerships and internal manufacturing operations including developing and maintaining relationships with site QA, QC, analytical and process development, manufacturing sciences and technology, and regulatory affairs functions.

• Supports the overall product quality strategy based on CMC / TCT deliverables, PD team objectives, life-cycle improvements, and regulatory commitments.

• Provides technical quality expertise and compliance oversight in accordance with global regulatory requirements and internal policies in support of commercial development efforts and life-cycle management activities.

• Supports Global Annual Product Quality Review deliverables for the product that include coordinating with leads of contributing chapters and ensure timely and compliant execution of the program

• Review clinical and commercial regulatory filings as needed.

• Serves as a delegate for the Global PQL in CMC/TCT meetings, Development team meetings, and general cell therapy governance meetings.

• Coordinates Product Quality Team meetings between Global PQL, Site QA/QC, Analytical Development, Process Development, Manufacturing Sciences and Technology, Product Sciences, and Regulatory Affairs.

• Coordinates product specific presentations to the Product Quality Review Board / Product Specification Committee and other product quality related cross-functional teams

• Serves as QA reviewer / approver for development reports, product specifications, and product labeling

• Supports Quality oversight and delegated launch readiness activities.

• Provide strategic guidance and facilitate the timely implementation of global changes with respect to the product. Owns global changes and documentation management activities as required.

• Assist in the continuous improvement and lifecycle management of GMP operations, including providing guidance and direction for transitioning from clinical to commercial phase

Qualifications and Education Requirements

• BS/MS in relevant Science or Engineering discipline and 10+ years of experience in Quality in a biotech, pharmaceutical, or bio-pharmaceutical organization; 1-3 years of experience in a supportive PQL role is preferred

• Expertise in GMP compliance, global regulations and strong understanding of pharmaceutical product development lifecycle are required

• 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

• Demonstrated ability in decision making and problem solving is required

• Demonstrated Quality leadership through partnership in a matrixed-organization is required

• Background in Biologics or Cell Therapy Manufacturing is required

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

• Experience with review of market applications, IND, supplements or similar regulatory documentation is required

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.