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.
Requirements:
- 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%.
Benefits:
- 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.
How Jobgether works:
We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team.
We appreciate your interest and wish you the best!
Why Apply Through Jobgether?
Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time.
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