Associate Director, Principal Product Quality Leader, Cell Therapy Global Product Quality

Posted 12 days ago
Main Location
New York City, NY, United States
Open jobs

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 Responsibilities

·         Provide global product quality oversight over assigned areas of responsibility and support manufacturing operations including developing and maintaining relationships with other QA, QC, development, analytical, manufacturing sciences and technology, and regulatory functions.

·         Supports the overall product quality plan based on Product Development Team objectives, regulatory commitments, and process and product monitoring KPIs as directed by the Global PQL.

·         Assists and may provide quality expertise in accordance with global regulatory requirements and internal policies in the creation of Product Characterization, Product Specifications, Method Validation, Stability and Comparability assessments for tech transfers

·         Supports Global Annual Product Quality Review deliverables (as required) that may include coordinating with leads of contributing chapters and ensure timely and compliant execution of the program

·         May act as quality reviewer of CMC sections of Regulatory submissions and response to global agencies queries; may author CMC sections or responses to queries, as needed.

·         May represent Global Product Quality in CMC meetings with global regulatory agencies and during regulatory inspections

·         May represent Quality in the Global CMC and Commercialization teams

·         Supports the Product Specification Committee relating to program specific topics, and other product quality related cross-functional teams

·         Act as QA approver for product specifications and product labeling  

·         Provides supportive quality oversight and guidance during product launch

·         Provide strategic guidance and facilitate the timely implementation of global changes with respect to the assigned product.  May own 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 7+ years of experience in Quality in a biotech, pharmaceutical, or bio-pharmaceutical organization; 1-3 years of experience in a PQL role is preferred

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

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

·         Demonstrated ability in decision making and problem solving is required

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

·         Background in Biologics, Viral Vector, or Cell Therapy Manufacturing is required

·         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.

Mission
We're a community of women leveraging our connections into top companies to help underrepresented women get the roles they've always deserved. Simultaneously, we work to build truly inclusive hiring processes and environments where women can thrive and not just survive.
Are you hiring? Join our platform for diversifiying your team
Associate Director, Principal Product Quality Leader, Cell Therapy Global Product Quality
Bristol Myers Squibb