Quality Product Lead - Marketed Products

This position is the primary point of Quality contact for the assigned Key Brand(s) within the Global Product Development and Supply network. 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 Key Brands & Manufacturing Quality and is accountable to guide and manage challenges to meet Global Supply requirements for the respective brand(s). 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 Key Brands & Manufacturing Quality organizations through established aligned annual objectives and defined roles and responsibilities:

• Acts as the single Quality point-of-contact for the assigned brand(s) and/or back-up contact for select brands.
• Assists in the development and execution of the Quality Plan and associated identification of risks and strategic risk and/or impact mitigation plans for the respective brand(s).
• Assists with the coordination and generation of End-To-End Annual Product Quality Review reports and/or the Yearly Product Quality Review reports to assure a holistic view for the brand(s).
• Responsible for optimization of end to end supply chain quality for their respective brand(s) in conjunction with the Director, Key Brands Quality and Compliance 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 / plans.
• Acts as single point of contact and Quality approver for product-related Level 2 and 3 changes for assigned brand(s).
• Regulatory CMC liaison responsible for reviewing and/or coordinating reviews of regulatory filings and responses to Health Authority inquiries.
• Engaged member of the GO-Team, Technical Product Team (TPT), and/or TPT sub-teams for assigned brand(s).

Education:

Minimum of a Bachelor's degree in a Natural Science, Pharmacy, Engineering, or other Healthcare-related field.

Experience/Knowledge:

• 10-12 years of 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

Skills/Competencies:

• 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 operations or technical support.
• Demonstrated strategic thinking capability with strong project management skills and ability to focus on execution of strategic decisions while balancing conflicting priorities.
• Demonstrated ability to influence areas not under direct control to achieve shared objectives and effectively communicate 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.

Travel Required:

Up to 25% travel expected based on job responsibilities (e.g. network-wide support).

Location:

Devens, MA is the preferred location for this role, however, consideration will be given for other site locations within the network.