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

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 PTxs 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 Sites 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 PTxs 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 PTxs 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.

KNOWLEDGE SKILLS ABILITIES

Required:

• 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.

Preferred:

• 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.

PEOPLE LEADERSHIP QUALIFICATIONS

Required:

• 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. Formal interview training is a plus.
• 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.

EXPERIENCE & EDUCATION

Required:

• 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.

Preferred:

• Bachelors degree preferably in science or engineering. (Bachelors degree or equivalent in related field may substitute for 2 years of professional experience.

PTx is committed to the principles of pay equity and providing competitive compensation for all of our Partners. The current pay range for this position is $150000 - $170000: Offers are made within the base pay range applicable at the time. Your salary will vary depending on several factors including your qualifications and experience.

In addition to medical dental vision FSA/DCA HRA disability and life insurance coverage all full-time regular Partners enjoy a casual and Hybrid or Remote workplace program for many roles. We offer a 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. To support a healthy work-life balance we also provide a gym subsidy wellness participation programs and a generous vacation sick and holiday paid time off program in addition to a paid shutdown between the Christmas and New Years holidays.

Partner Therapeutics is an Equal Opportunity Employer and does not discriminate on the basis of race color religion sex age national origin veteran status marital status sexual orientation gender identity disability or any other category prohibited by local state or federal law. This policy applies to all aspects of employment including recruitment placement promotion transfer demotion compensation benefits social and recreational activities and termination.