Vice President, Quality & CMC Regulatory Affairs bei Partner Therapeutics

VICE PRESIDENT, QUALITY & CMC REGULATORY AFFAIRS (REMOTE)

POSITION SUMMARY

The Vice President, Quality & CMC Regulatory Affairs provides strategic vison, leadership and direction to the Partner Therapeutics Quality organization.  The Vice President is also a member of the Company’s Executive Leadership Team (ELT) and responsible for ensuring products and processes meet regulatory and industry standards, customer expectations, and Company objectives.  The Vice President will play a critical role in shaping the Company's Quality Culture through implementing compliance initiatives, and driving continuous improvement to support delivery of pharmaceutical products to patients around the globe. Travel to a PTx site approximately once a month, with additional travel to conferences, seminars, and vendors as needed.

PRIMARY RESPONSIBILITIES

Visionary Leadership

• Provides visionary leadership to the Quality organization, inspiring a culture of innovation, collaboration, continuous improvement, and compliance consistent with PTx values.
• Sets clear strategic goals, objectives, and financial targets empowering teams to achieve excellence in performance and drives the organization forward.
• Is an active member of the ELT focused on thoughtful allocation of resources, assessment and mitigation of risk, and facilitation of cross-functional input to drive effective decision making.
• Compliance and Oversight
• Ensures compliance with global regulatory standards, including FDA, EMA, PMDA and ICH guidelines.
• Oversees the design, implementation, and maintenance of the Quality Management System to support commercial and clinical manufacturing activities.
• Leads preparation activities for and responses to regulatory inspections, audits, and interactions.
• Develops key quality metrics to identify trends, assess risks, and implement proactive solutions.

CMC Regulatory Affairs

• Serves as the senior authority on CMC regulatory strategy, overseeing the preparation, review, and submission of high-quality regulatory documentation.
• Leads regulatory interactions with agencies including FDA, EMA, PMDA, and other global authorities, ensuring alignment on CMC expectations and timely resolution of queries.
• Provides strategic input into regulatory filings and lifecycle management, including change control, comparability assessments, and post-approval commitments.
• Ensures robust documentation and traceability of CMC decisions and regulatory correspondence.

Strategic Planning and Execution

• Develops and implements a global quality strategy aligned with corporate goals and regulatory requirements.
• Drives a culture of quality excellence, compliance and continuous improvement across the organization to enhance quality, efficiency, and cost effectiveness.
• Monitors budgets, key performance indicators, and metrics to track operational performance and identifies areas for improvement or intervention.
•  Cross-Functional Collaboration
• Proactively influences cross-functional Partners to ensure quality principles are integrated into processes and systems supporting the manufacturing and release of product.
• Fosters strong relationships and effective communication channels across all functions to facilitate seamless integration, collaboration, and creative solutions.
• Promotes a cohesive and collaborative work environment by breaking down or preventing organization barriers.
• Technology and Innovation Adoption
• Evaluates/monitors new technologies, methodologies, and tools to improve testing processes that align to current industry standards and best practices.
• Engages with industry experts, professional associations and conferences to enhance the Company’s competitiveness and informed decision making related to quality processes and programs.  

 Quality Risk Management and Mitigation

• Proactively identifies and assesses quality risks that could impact patient safety and implements risk mitigation strategies.
• Ensures adequate and appropriate resources are available for thorough and timely management of the quality risk management process.

Talent Development and Succession Planning

• Develops and mentors a diverse, high-performing team of Quality professionals, fostering their growth, development, and facilitates succession planning.
• Cultivates a culture of learning, development, and accountability, empowering team members to take ownership of their roles and contributes to the achievement of strategic objectives.
• Stakeholder Engagement and Relationship Management
• Cultivates strong relationships with key stakeholders.
• Prepares regular, concise updates to the Board on performance to goals, risk, and opportunities to optimize value to the organization.
• Represents the Company externally in industry forums, conferences, and events, advocating for the Company's interests.

KNOWLEDGE, SKILLS, ABILITIES

• Strategic thinker with a visionary mindset, capable of anticipating future trends and driving innovation of Quality Management Systems, Quality Control and CMC Regulatory Compliance.
• Skilled at managing multiple projects and resources simultaneously.
• Strong critical thinking, analytical, and problem-solving skills with the proven ability to formulate strategic solutions that propel the organization forward.
• Demonstrated ability to delegate successfully.
• Strong written and oral English communication skills, including an ability to facilely use software platforms.

PEOPLE LEADERSHIP QUALIFICATIONS

• Strong people leadership skills including demonstrated ability to drive accountability and build a culture of trust, compliance, efficiency, and continuous improvement.
• Demonstrated commitment to fostering the professional growth and development of others.
• Experienced at managing and developing the performance of direct reports by setting clear “SMART” goals, providing timely performance feedback, recognizing, and rewarding high achievers, and holding team accountable.

EXPERIENCE & EDUCATION

• 15+ years of progressively responsible experience in Quality management and/or Regulatory management with proven track record of leadership and achievement in a senior role.
• 10+ years in People Leadership roles leading Quality or Regulatory teams in a regulated environment.
• Strong grasp of GMP/GLP and global regulatory frameworks, with the ability to navigate evolving requirements.
• Bachelor’s degree in engineering, science, or a related field. Advanced degree preferred.

PTx is committed to the principles of competitive and pay equity for all of our Partners. The current pay range for this position is $275,000 - $325,000: 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 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.