Senior Director Commercial GMP Quality

Role Summary

The Senior Director, Commercial GMP Quality is responsible for leading the development, execution, and continuous improvement of GMP Quality strategies, programs, and systems to support late-stage and commercial manufacturing operations. This role ensures that all products manufactured for Mineralys meet the highest standards of quality and comply with all applicable regulatory requirements, industry best practices, and internal policies. Reporting to the SVP of Quality, this individual serves as a key member of the Quality leadership team and collaborates cross-functionally to drive quality excellence across the product lifecycle.

Responsibilities

• Lead the development and execution of the Commercial GMP Quality strategy aligned with corporate objectives and regulatory expectations.
• Serve as the primary GMP Quality leader for commercial manufacturing activities, providing direction and oversight for both internal teams and external partners.
• Partner with cross-functional leadership to support product launches, tech transfers, and lifecycle management initiatives.
• Oversee the design, implementation, and governance of robust GMP Quality Systems, including deviations, CAPAs, change control, batch record review, product disposition, and quality metrics.
• Ensure continued inspection readiness across all GMP operations, including proactive risk management and mitigation strategies.
• Provide final Quality review and disposition of commercial drug product and drug substance, ensuring timely release in accordance with regulatory and internal requirements.
• Ensure compliant and efficient review of master and executed batch records, including investigation resolution and traceability documentation.
• Serve as the senior quality representative for GMP contract manufacturers (CMOs), testing labs, and other service providers supporting commercial operations.
• Oversee quality agreements, external audits, and performance monitoring to ensure adherence to Mineralys standards and applicable regulations.
• Lead GMP-related inspections and audits (e.g., FDA, EMA) and manage responses and follow-up actions.
• Direct internal and external audit programs, including risk-based audit planning, execution, and CAPA closure.
• Foster a proactive quality culture with a focus on continuous improvement, right-first-time execution, and operational excellence.
• Leverage data and quality metrics to drive decision-making and promote transparency with senior leadership.

Skills

• Flexibility to adapt to a fast-changing, ambiguous environment in an organization without fully established procedures
• Velocity – Drive Speed with Purpose
  • Foresight & Acceleration
  • Execution Under Tight Timelines
  • Clear Decision-Making in Ambiguity
• Data-Driven Decision Making – Ground Strategy in Evidence
  • Subject Matter Intelligence & Precedent-Based Reasoning
  • Data Interpretation
  • Metrics-Oriented
• Agile Mindset – Embrace Iteration and Change
  • Adaptability to Shifting Development Plans
  • Iterative Planning & Engagement
• Frictionless Execution – Simplify the Path to Results
  • Operational Clarity & Precision
  • Lean, Cross-Functional Collaboration
  • Strategic Communication
• Autonomy – Lead with Ownership and Accountability
  • Self-Directed and Proactive
  • Trusted Decision Maker
  • Leads from the Front
• Execution that Delivers Value
  • Define success up front
  • Follow through with discipline
  • Deliver results that move the business

Education

• Required: Bachelor's degree in life sciences, chemistry, or related discipline.
• Preferred: Ph.D. or advanced degree.

Qualifications

• Required: Minimum 15 years of experience in GMP Quality Assurance roles within the pharmaceutical or biotech industry, including at least 5 years in a senior leadership capacity.
• Required: Extensive experience in commercial manufacturing, product release, regulatory inspections, and third-party quality oversight.
• Required: Strong knowledge of global GMP regulations and industry best practices.

Additional Requirements

• Travel up to 25% with some international travel; frequent travel outside the local area and overnight.