Associate Director, Quality Product Lead, Early Assets
About the Job
At Bristol-Myers Squibb, we believe that together we can make the difference. We want to do this by building professional teams who can create and innovate medicines that benefit doctors and their patients.
Our large-scale biologics manufacturing facility in Devens, Massachusetts, is expanding and there are a number of exciting career opportunities to join Bristol-Myers Squibb, one of the world’s leading BioPharma companies.
We’ve created one of the world’s premier biologics facilities, among the first sites in the industry to have a fully automated, integrated manufacturing control system that enables the plant to run virtually paperless. It is a site that combines biologics development with clinical and commercial manufacturing on a single campus – a true biologics center of excellence for the company where teams are encouraged to closely collaborate. This expansion was designed to support the launch of new medicines by more closely aligning biologics development and manufacturing capabilities. All this goes towards helping create and innovate life-saving medicines that fight serious illnesses.
The EA-QPL is responsible to serve as the primary point of Quality contact for a collection of four to six clinical biologics assets. The EA-QPL works collaboratively with the Biologics Development Organization (BDO), Global Biologics Quality Extended Leadership Team (ELT) and other key stakeholders to develop, coordinate and oversee the quality and compliance elements of the product process and analytical strategy, including compliance oversight of the method, method validation and specification lifecycle.
The position will be responsible for employing an integrated, end-to-end strategic approach to ensure successful completion of developmental milestones from first-in-human through initial market regulatory submission and Health Authority approval providing for a foundation that assures a robust commercial control and testing strategy that enables speed to patient and reliable supply. While leading a small team of Compliance professionals, the EA-QPL will also ensure that program specific process and analytical technical documents are reviewed and approved in conjunction with overall IDT time lines to enable manufacturing and regulatory submission milestones.
• Acts as single point of contact for a collection of products during development and through initial US/EU commercial market approval for designated products.
• Responsible for providing consistent phase appropriate quality and compliance requirements and recommendations to products progressing through the clinical development phases that are aligned with the company’s risk profile and as codified in Directives and other guidance documents.
• Performs Biologics Quality review at the IDT review level for clinical and BLA/MAA regulatory filings.
• Performs the Quality review and approval of Justification of Specification documents for the designated programs.
• Assures the method and method validation deliverables and product specifications for first in human through initial market commercialization for designated programs.
• Assures the evaluation and approval (as required) for process related deliverables for first in human through initial market commercialization for designated programs.
• Accountable for relevant change management quality activities.
• Participate in the development of robust communication, tracking and knowledge management tools.
• Bachelor degree in Science, advance degree preferred
• In depth knowledge of biologics manufacture, testing, and global regulatory requirements for products moving from development through licensure.
• 10 years of relevant experience and demonstrated leadership with an in-depth knowledge of current regulatory expectations, phase appropriate quality and compliance processes and considerations, operations and development of robust testing and control strategies
• Demonstrated influential leadership expertise with Technical, Quality, and/or Regulatory functional areas.
• Ability to work in a matrix environment and build strong relationships by being transparent, reliable and delivering on commitments.
• Ability to provide innovative and risk-based effective ideas or alternatives that create value including seeking new information and external insights without compromising compliance.
• Capability to gain alignment amidst diverse perspectives with business partners and stakeholders
• Strong and demonstrated strategic thinking capability with strong project management focus and ability to focus on execution of strategic decisions while balancing conflicting priorities.
• Demonstrated ability to influence areas not under direct control to achieve objectives and program goals
• Experience in people management with a focus on developing talent and contributing actively to the organization talent agenda
• Demonstrated leadership capability with ability to make and act on decisions while balancing speed, quality and risk.
Together, we make a difference. Bristol-Myers Squibb is one of the world’s BioPharma leaders, committed to delivering innovative medicines as well as nurturing a culture that’s a springboard for progress. Our success depends on building teams of bold, innovative and passionate employees who will help continue to drive us further forward. No matter the role, we are united by our mission and determined to win this fight. And that makes all the difference. If you want to join us, apply now at www.bms.com/careers.