Vice President, Quality & CMC Regulatory Affairs

Partner Therapeutics • WA

127d • $275,000 - $325,000

About The Position

The Vice President, Quality & CMC Regulatory Affairs provides strategic vision, 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.

Requirements

• 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.

Responsibilities

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Benefits

• Medical, dental, vision, FSA/DCA, HRA, disability, and life insurance coverage.
• Casual, 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.
• Paid shutdown between the Christmas and New Year’s holidays.

What This Job Offers

• Job Type: Full-time
• Career Level: Executive
• Education Level: Bachelor's degree
• Number of Employees: 101-250 employees