Job Description
Team: Product
This position is posted by Jobgether on behalf of a partner company. We are currently looking for a Director, Product Quality Lead in United States.
This senior leadership role sits at the intersection of quality science, regulatory compliance, and product lifecycle strategy within a global oncology-focused organization. You will be responsible for driving product quality excellence across late-stage clinical and commercial programs, ensuring robust quality systems, and embedding compliance into every stage of development and manufacturing. Acting as a key connector between R&D, manufacturing, and regulatory functions, you will influence critical decisions that impact patient safety, product effectiveness, and global market access. The role combines strategic oversight with hands-on leadership in quality risk management, investigations, and governance. You will also lead cross-functional initiatives that strengthen quality culture, data-driven decision-making, and continuous improvement. This is a highly collaborative and mission-driven environment focused on improving access to life-saving medicines worldwide.
Accountabilities:
- Lead global product quality strategy across late-phase clinical and commercial programs, ensuring compliance with regulatory requirements and internal quality standards.
- Serve as a Subject Matter Expert in quality risk management, investigations, change control, and resolution of complex quality issues, including CMC regulatory content review.
- Represent the quality organization in governance forums and cross-functional product/platform-level meetings.
- Manage Product Quality Network teams and oversee deliverables across multiple programs and global stakeholders.
- Partner with R&D, CMC, manufacturing, and regulatory teams to embed quality considerations into product development and lifecycle management.
- Define and advise on CMC strategies, including specifications, stability, comparability, and in-process controls.
- Lead implementation and enhancement of Quality Risk Management frameworks aligned with ICH Q9 and global regulatory expectations.
- Drive product quality performance monitoring, trend analysis, and continuous improvement initiatives.
- Support regulatory inspections and audits, ensuring readiness and alignment with global standards.
- Mentor and develop team members, strengthening technical expertise and leadership capability within the quality organization.
- Bachelor’s degree with 8+ years of experience in quality sciences, quality systems, or related regulated industry (pharma, biotech, or medical devices).
- Master’s degree preferred with 10+ years of relevant experience.
- 5+ years of managerial or leadership experience managing teams, programs, or cross-functional initiatives.
- Strong expertise in quality systems, regulatory frameworks (FDA, EMA), and risk management methodologies (ICH Q9).
- Proven experience in leading investigations, quality risk management, and implementation of quality systems or new technologies.
- Strong analytical thinking and problem-solving skills with the ability to manage complexity and ambiguity.
- Proficiency in quality tools such as root cause analysis, Lean, Six Sigma, and related methodologies.
- Experience developing training programs and building SME networks in a global organization.
- Strong communication skills with the ability to translate complex technical topics across diverse stakeholders.
- Proficiency with MS Office; experience with statistical and analytics tools such as Minitab, JMP, Tableau, or SciLab is preferred.
- Willingness to travel up to 20%.
- Competitive annual salary range: 172,000 – 232,000 USD.
- Annual bonus eligibility and incentive compensation depending on role type.
- Discretionary equity awards and employee stock purchase plan participation.
- Comprehensive benefits including medical, dental, vision, life insurance, and wellness programs.
- 401(k) retirement plan with additional financial planning options (FSA/HSA).
- Paid time off and flexible leave policies.
- Global career development opportunities within a fast-growing, mission-driven organization.
- Strong emphasis on training, continuous learning, and leadership development.
Requirements:
Benefits:
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Date Posted
05/04/2026
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