Sr. Manager, Product Release & Supplier Compliance (Hybrid)

Location: Lynnwood,Washington,United States

POSITION SUMMARY

The Sr. Manager, Product Release & Supplier Compliance (Sr. Manager) will be responsible for leading and managing the day-to-day activities of the Northpointe site Quality Assurance Product Release and Supplier Compliance teams. The Sr. Manager will oversee the team supporting raw material, biologic cell banks, and bulk drug substance release and supplier compliance processes. The individual is responsible for ensuring the quality unit procedures and performance aligns with standard operating procedures, good manufacturing practices, regulatory compliance requirements, and current industry guidance.

PRIMARY RESPONSIBILITIES

Functional:

• Responsible for both leading the team and hands-on execution in the disposition of raw material, Master Cell Bank (MCB), Working Cell Bank (WCB), and biologic drug substance product (BDS).
• Provides team leadership and hands-on execution for the quality review and approval of GMP documentation, including SOPs, batch records, deviations, change controls, nonconformances, risk assessments, and all records required to support compliant GMP manufacturing.
• Review of manufacturing data, and the Annual Product Review (APR).
• Responsible for PTx’s Supplier Qualification Program, including supplier change notifications and supplier risk management; leading the team, continuous improvements, problem solving, and hands-on execution.
• Maintains current and accurate supplier and site subcontractor Quality Technical Agreements (QTAs).
• Develops and manages metrics to monitor and improve processes.
• Anticipates, identifies, and communicates risks while partnering to create strategies and plans to manage risk.
• Prepares for inspection readiness to ensure compliance during audits and inspections. Interfaces with external audit functions as needed to represent the site and Quality function.
• Participates in the development and prioritization of the NP Site’s Life Cycle Management Plan.
• Resolves “stuck” issues by ensuring timely escalation to Leadership and cross-functional teams: Applies learning from these events and leads the creation of new/updated systems, processes, programs to prevent similar situations in the future.
• Through self-education and external networking/participation in industry and professional organizations keeps abreast of current industry trends, compliance requirements, and best-of-class technologies relating to area of responsibility. Actively applies learned best practices, knowledge, and benchmarking to PTx projects and solutions.
• Pursues participation or leads project teams outside normal course of work (i.e. “collateral duties”) as they become available to support personal growth, connection, and business needs.
• Adheres to all applicable regulations and requirements including compliance with internal SOPs, GMP, Health and Safety, WISHA/OSHA, regulatory compliance, company policies, and employment-related laws and statutes.
• Successfully completes all mandatory Quality and Compliance training within required time frames.

People Leadership:

• Builds, develops, inspires, motivates, and leads a diverse, professional team. Sustains high performance that is strongly aligned and coordinated with other functional groups across the organization; ensures Partner engagement by creating a culture of inclusion, execution, and an environment within which they can excel and continuously improve.
• Establishes individual goals and objectives in alignment with department goals and priorities.  Identifies performance improvement targets and metrics. Ensures capabilities and capacity are in place to effectively deliver on all departmental commitments and performance targets.
• Recommends and allocates resources - human, technical, etc. - to fulfill near term goals and commitments while building towards sustainable excellence.
• Leads by example and promotes PTx’s core Values: Learn, Prepare, Innovate, Collaborate, Lead to continually improve the Quality Culture at PTx.
• Meets consistently with all Direct Reports individually and as a team utilizing site tools (such as the GOOD 1:1 and PERFORM) to ensure 2-way updates, conversations, and alignment on goals and priorities are clear and reinforced regularly. Pro-actively creates opportunities to develop their Team, including ensuring career paths have been developed for Partners, and enhances the Team through cross-training others, identifying competency gaps, etc. 
• Through active leadership and coaching, while embracing PTx’s Values and Behaviors, holds Team accountable for compliance to all safety and quality regulations, ensures all team members directly or indirectly support cGMP