Director, Product Quality Lead
New
USFull-TimeDirector
Salary172,000 - 232,000 USD per year
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Job Details
- Experience
- Bachelor’s degree with 8+ years of experience; Master’s degree preferred with 10+ years of relevant experience.
- Required Skills
- Product DevelopmentMS Office
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%.
Responsibilities
- 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.
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