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

Partner Therapeutics•Lynnwood, WA

31d•$150,000 - $170,000•Hybrid

About The Position

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.

Requirements

Possesses a deep background in Quality Assurance and Regulatory Compliance within the biotech or pharmaceutical industry including working in a cGMP manufacturing environment.
Demonstrates proficiency in fermentation and purification biologic product disposition, supplier qualification, supplier change notification, and supplier risk management.
Possesses comprehensive knowledge of FDA regulations and experience with US regulatory agency audits and inspections in the biopharmaceutical industry, including but not limited to biologic cell bank, and bulk drug substance manufacturing.
Expert level experience in document control, inspection readiness and regulatory audit inspection support.
Resourceful with proven ability to lead, manage, and leverage an internal network of stakeholders and team members to plan and resolve issues.
Strong 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 solutions to propel the organization forward.
Possesses strong organizational and prioritization skills to maintain a high level of productivity and priority-setting in order to complete assignments on-time and on-budget.
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 within own function.
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.
Demonstrated commitment to fostering the professional growth and development of others.
Knowledge of standard interviewing protocols; recent experience participating in the hiring process as an interviewer or hiring manager.
Strong leadership skills including a demonstrated ability to drive accountability and build a departmental culture of trust, compliance, efficiency, and continuous improvement.
Proven ability to enhance engagement by creating an environment within which individuals and teams can excel and continuously improve.
Skilled at active listening, conflict resolution, and team building.
Experience working collaboratively with HR/People & Culture functions to recruit, hire, grow, and retain talent.
Formal training in essential people management skills.
High School Diploma or GED.
10+ years of progressively responsible experience in the Quality function within the Pharmaceutical/Biotech industries including significant experience supporting key functional areas including Manufacturing, QC, and Supplier Compliance.
8+ years in People Leadership or project Lead roles.
People Leadership qualification includes experience in recruiting, making hiring decisions, setting SMART Goals, growing high performers, and addressing performance concerns.
“Lead” qualification includes time in a formal Lead role, and/or leading project teams, collateral activity teams, and participating on interview panels.

Nice To Haves

Practical understanding of principles of project management; formal project management training a plus.
Recent experience with workforce planning.
Software application experience with Smartsheet, MS Project, and SharePoint.
Formal interview training is a plus.
Bachelor’s degree, preferably in science or engineering. (Bachelor’s degree or equivalent in related field may substitute for 2 years of professional experience.

Responsibilities

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.
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 activities, and have the necessary education, knowledge, and skills to perform their job in accordance with applicable procedures and regulations.
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.

Benefits

medical, dental, vision, FSA/DCA, HRA, disability, and life insurance coverage
casual, and Hybrid or Remote workplace program for many roles
pre-IPO options
annual cash bonuses
401k matching
free parking or Seattle-area ORCA pass
tuition assistance
rewards for achievement and contribution
gym subsidy
wellness participation programs
generous vacation, sick, and holiday paid time off program in addition to a paid shutdown between the Christmas and New Year’s holidays