Associate Director, External Manufacturing & Product Release

About the position

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.

Responsibilities

• 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.
• 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. 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 Report(s) in the GOOD 1:1 format and as a team to ensure 2-way updates, conversations, and alignment on goals and priorities are clear and reinforced regularly.
• 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 activities, and have the necessary education, knowledge, and skills to perform their job in accordance with applicable procedures and regulations.
• Pro-actively creates opportunities to develop their Team, including ensuring career paths have been developed for Partners (as needed), and enhances the Team through cross-training others, identifying competency gaps, etc.

Requirements

• Direct experience in overseeing quality events and effective CAPA implementation with contract manufacturer organizations.
• Deep knowledge of clinical and commercial labeling requirements for both US and non-US territories.
• Responsible for the development, continuous improvement, coordination and ensuring compliance for all Quality aspects of the lifecycle stages of CMO Management.
• Comprehensive knowledge of FDA regulations and experience in US regulatory agency audits and inspections of the biopharmaceutical industry, including but not limited to, aseptic processing of biologics.
• Experience with QP release requirements, including Product Specification Files.
• Proven ability to efficiently lead a QA function that is responsible for oversight of external manufacturing, product release and labelling.
• Proven project management, process improvement, and change management skills.
• Possesses deep understanding of the patient and stakeholder/customer viewpoint.
• Skilled at building trust and collaboration by delivering exceptional service while balancing the needs of the individual with the greater good.
• Resourceful with proven ability to lead, manage and leverage an extensive internal network of stakeholders, team members, and external resources to plan and resolve issues.
• Strong, collaborative relationship management and interpersonal skills required to quickly gain confidence of stakeholders and team members.
• Strong critical thinking, analytical, and problem-solving skills with the proven ability to formulate strategic solutions to propel the organization forward.
• Possesses strong organizational and prioritization skills to maintain a high level of productivity, innovation, and priority-setting in order to complete assignments on-time and on-budget; experience with the principals of operational excellence.
• Demonstrated ability to delegate successfully.
• Excellent soft skills including a bias towards action, the ability and willingness to give and receive constructive feedback, is comfortable working within a diverse team and across multiple functions, exhibits a consistently constructive attitude, and is adaptable and at ease with handling unexpected changes and challenges.
• Strong written and oral English communication skills are required for this highly collaborative role.
• Proven ability to make clear, effective, and persuasive presentations to audiences at various levels of expertise required.
• Skilled at leading effective meetings.
• Solid software skills essential including Word, Excel, PowerPoint, Outlook; ability and willingness to quickly adopt other job-specific applications will be necessary.

Nice-to-haves

• Seasoned in electronic Quality Systems and use (e.g. Track wise, Master Control, Veeva)
• Formal project management training.
• Experienced with workforce planning and operational budgeting.
• Software application experience with Smartsheet, MS Project, and SharePoint.

Benefits

• Medical, dental, vision, FSA/DCA, HRA, disability, and life insurance coverage.
• Casual, Hybrid or Remote workplace program for many roles.
• Terrific compensation/benefits/perks package which includes pre-IPO options, annual cash bonuses, 401k matching, free parking or Seattle-area ORCA pass, tuition assistance, plus rewards for achievement and contribution.
• Gym subsidy, wellness participation programs, and a generous vacation, sick, and holiday paid time off program.
• Paid shutdown between the Christmas and New Year’s holidays.