Associate Director, External Manufacturing & Product Release

Location: Lynnwood,Washington,United States

ASSOCIATE DIRECTOR, EXTERNAL MANUFACTURING & PRODUCT RELEASE (REMOTE)

POSITION SUMMARY

The Associate Director, External Manufacturing & Product Release is responsible for leading the programs that support the oversight of PTx’s external manufacturing suppliers and product release (commercial and clinical).  This individual will be responsible for not only ensuring these programs adhere to industry requirements, but also proactively identifying opportunities for improvements and efficiencies and the development of KPIs to monitor performance and control.

PRIMARY RESPONSIBILITIES

Functional:

• Responsible for GxP oversight of External Manufacturing Organizations and business partners involved in the manufacture, testing, and transport of products.
• Ensures timely Quality review/approval of CMO deviations, change controls and batch release requirements and integrates these records into Partner Therapeutics’ (“PTx”) cGMP systems.
• Responsible for change control implementations at CMOs, including timely Quality review/approval of documents and coordinating impact assessments from Subject Matter Experts.
• Responsible for disposition Drug Product (DP), Finished Product (FP) for commercial and clinical products.
• Ensures timely Quality review/approval of documents required to support technology transfer.
• Monitors and manages the performance of CMOs, including quality, cost, and delivery metrics. 
• Supports PTx Regulatory Intelligence role in the development and implementation of updates affecting CMO operations.
• Supports PTx inspection readiness for CMO activities in alignment with good manufacturing practices, regulatory compliance requirements and current industry standards, including inspection walkthrough and preparedness activities, response management, and tracking.
• Collaborates and provides subject matter expertise in product quality issues/events, Continued Process Verification (“CPV”), and product technical transfer.
• Anticipates, identifies, and communicates risks in area of responsibility; creates strategies and plans to manage risk to the operations.
• Oversees and contributes to the creation of policies, procedures, standards, and controls to enhance the support and adherence to U.S. and applicable international GMP regulatory agencies.
• 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 timeframes.
• Resolves “stuck” issues by ensuring timely issue 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.

People Leadership:

• Establishes departmental and individual goals and objectives in alignment with Site 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, financial, technical, etc. - to fulfill near and long-term goals and commitments while building towards sustainable excellence.
• 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.
• Works pro-actively and in close collaboration with upline Leadership Team and People & Culture to recruit, hire, grow, and retain a diverse team of talent.
• Manages and develops the performance of direct reports by setting clear SMART goals, provides and seeks timely performance feedback, recognizes and rewards high achievers, and holds team members accountable for underperformance.