Quality Product Lead

Location
Devens, MA, United States
Posted
Sep 24, 2020
Ref
R1528218
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.

Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.

One shared journey is moving us forward at Bristol-Myers Squibb. Around the world, we are passionate about making an impact on the lives of patients with serious disease. Empowered to apply our individual talents and ideas so that we can learn and grow together. And driven to make a difference, from innovative research to hands-on community support. 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.

The Associate Director, Quality Product Associate Lead (QAPL)- Marketed Products serves as the primary Global Biologics Quality representative key brands and supports the development, coordination and ownership of the quality and compliance elements of the brand and life cycle strategy, including owner of the global change management implementation plan, end-to-end preapproval inspection readiness and launch readiness. The QPL works collaboratively with the Director, Quality Product Lead (QPL) and other Global Quality team members to ensure continuity of supply and end-to-end optimization across the brand Lifecycle. In addition, this role assists with the planning and execution of the Quality component of the Product Strategic Plan including, but not limited to: global change control strategy, Annual Product Quality Review, Product Lifecycle initiatives, Product Robustness Plans, and Product Risk Assessments.
Additionally, the QPL is accountable for filing and inspection readiness for line extensions and other major process changes (as applicable). In addition, this position serves as the escalation coordination point on behalf of Global Quality and is accountable to guide

and manage challenges to meet Global Supply requirements for the brand.

The QPL is responsible for collaborating and networking across the global Quality organization to reach compliant solutions. This position will facilitate and be supported by the broader site and Global Quality organizations through established aligned annual objectives and defined roles and responsibilities:
  • Acts as the single Quality focal point for the marketed brands and/or back-up contact for select products.
  • Assists in the development and execution of the Quality BOW and associated identification of risks and strategic risk and/or impact mitigation plans.
  • Assists with the coordination and generation of End-To-End Annual Product Quality Review reports to assure a holistic view for the brand. in conjunction with the Director, Quality Product Lead and other key stakeholders.
  • Evaluates impact of proposed process changes on the end to end supply chain and develops, executes, and oversees change implementation strategies I plans.
  • Quality approver for changes that have regulatory impact.
  • Acts as single point of contact and Quality responsible for reviewing and/or coordinating reviews of regulatory submissions and responses to Health authority inquiries.
  • Engaged member of the GO-Team, Technical Product Team (TPT, and/or TPT sub-teams for Orencia.
  • Quality partner with site operations for key brand project and operational support for support of brand book of work
  • Support end to end view into product quality complaints
  • Author Quality chapter for brand strategy document.


Education:
  • Minimum of a Bachelor's degree in a Natural Science, Pharmacy, Engineering, or other Healthcare-related field.
  • 10-12 years' experience in a technical, quality, and/or regulatory role within the biopharmaceutical industry with demonstrated leadership in Quality Management
  • In-depth knowledge and hands-on experience interpreting current regulatory expectations and developing sound quality and compliance systems and processes


Experience/Knowledge Desired:
  • Demonstrated influential leadership expertise and experience working with and/or supporting Technical, Supply Chain and Regulatory functional areas.
  • Capability to build alignment amidst diverse perspectives with business partners including research and development, and manufacturing at a global and site level.
  • Experience in Biologics or pharma operations or technical support.
  • Demonstrated strategic thinking capability with strong project management skills and ability to focus on execution of strategic decisions while balancing mulitple priorities.
  • Demonstrated ability to influence other functional areas achieve shared objectives and effectively communicate objective status.
  • Self-starter who views challenges as opportunities to improve.
  • Demonstrated leadership capability with ability to align on, make and act on decisions while balancing speed, quality and risk.
  • Ability to work in a matrix environment and build strong relationships by being transparent, reliable and delivering on commitments.
  • Ability to provide innovative ideas or alternatives that create value including seeking new information and external insights without compromising compliance.


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.