POSITION SUMMARY

This Associate Director, Quality is responsible for leading the programs that support Product Quality, Supplier Quality, and Post Market activities for PTx’s commercial products and is a member of the Quality Leadership Team. 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

• Responsible for PTx’s Supplier Qualification Program; leading the team, continuous improvements, problem solving, and hands-on execution
• Leads and oversees the completion of the PTx Annual Product Review (APR)
• Facilitates the Regulatory Surveillance program and collaborates with cross-functional Partners to ensure the implementation and compliance of emerging regulations, trends, and updates to USP chapters
• Oversees Product Complaints, Biological Product Deviation Reports (BPDR’s) and Product Recalls
• Collaborates with business process owners/functional areas to develop and author Quality Technical Agreements (QTA)
• Oversees and facilitates Commercial Label Management and Product Serialization functions
• Collaborates and provides Subject Matter Expertise in Product Quality issues/events, Continued Process Verification (CPV), and product technical transfer
• Supports gap assessment/evaluation and requirements for non-US markets
• Facilitates the PTx Corporate Quality Council
• Regularly participates cross-functionally on project teams outside of the Quality function to drive our business forward
• Expands industry network by participating in outside industry activities, user groups, and/or professional associations to support integrating best practices and benchmarking into PTx

KNOWLEDGE, SKILLS, ABILITIES

• Detailed knowledge of Quality Management Systems (QMS) and use in electronic platforms required
• Proven project management, process improvement, and change management skills required; formal training in Lean principals strongly preferred
• Skilled with MS Project or Smartsheet applications required
• Proven ability to work collaboratively with inter-departmental and cross-functional teams in order to drive accountability and lead changes in a timely and effective manner required
• Demonstrated ability and willingness to apply sound business judgement and effective decision making to drive the strategic objectives of the department required
• Skilled at managing multiple projects and resources simultaneously required
• Demonstrated willingness to challenge constructively, address issues (performance, business, etc.) and recognize positive performance both inside and outside areas of responsibility required
• Excellent communication skills (both technical and non-technical) in written, verbal and presentation format. Ability to make effective and persuasive presentations on complex topics to top management, public groups, and internal customers required.

PEOPLE LEADERSHIP QUALIFICATIONS

• At least 5 years of people leadership and team building experience preferred, including expertise in inspiring and building highly effective teams while managing for high performance and developing others
• Experience in and proven ability to lead, manage, and collaborate in a multi-cultural, team-based environment
• Comfortable operating in an evolving, complex, and sometimes ambiguous environment, while providing clear direction and instruction to your team required
• Demonstrated success in working up and down the management stack, including at executive levels, in order to recommend, influence, and gain agreement for proposed changes
• Recent experience developing and monitoring metrics/KPI’s required

EXPERIENCE & EDUCATION

• BA, BS, or equivalent in a science or technical discipline required
• Advanced degree a plus, evidence of continuous learning required
• 15+ years progressively responsible experience in the Quality function within the Pharmaceutical/Biotech industries including significant experience in supporting key functional areas including Manufacturing, QC, and Validation required
• Experience effectively interfacing with outside business partners and regulators
• Six Sigma Certification a plus

To ensure we are able to consistently provide Leukine to patients around the world and in support of our friends, families, and neighbors, Partner Therapeutics requires all current and future employees to be fully vaccinated against COVID-19. We require evidence of COVID-19 vaccination prior to hire, subject to reasonable accommodation and other requirements of applicable federal, state, and local law.

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 Year’s 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.