Senior Director Commercial GMP Quality at Mineralys Therapeutics

, , United States -

Full Time

Start Date

Immediate

Expiry Date

19 Dec, 25

Salary

0.0

Posted On

20 Sep, 25

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

GMP Quality, Regulatory Compliance, Quality Systems, Continuous Improvement, Data-Driven Decision Making, Strategic Leadership, Operational Excellence, Risk Management, Cross-Functional Collaboration, Quality Culture, Inspection Readiness, Product Release, Audit Readiness, Agile Mindset, Metrics-Oriented, Trusted Decision Maker

Industry

Biotechnology Research

Description

Mineralys Therapeutics is a publicly traded, clinical-stage biotechnology company focused on developing medicines to target diseases driven by abnormally elevated aldosterone. Our initial product candidate, lorundrostat, is a proprietary, orally administered, highly selective aldosterone synthase inhibitor that we are developing for cardiorenal conditions affected by abnormally elevated aldosterone, including hypertension and chronic kidney disease. Mineralys is a fully remote company. For more information, please visit https://mineralystx.com. Follow Mineralys on LinkedIn. Senior Director Commercial GMP Quality 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. Principal Responsibilities Strategic Leadership & Oversight 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. Quality Systems & Compliance Oversee the design, implementation, and governance of robust GMP Quality Systems, including but not limited to 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. Batch Release & Product Disposition 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. External Manufacturing Oversight 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. Regulatory Inspection & Audit Readiness 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. Quality Culture & Continuous Improvement 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 and Attributes 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 Travel This position requires up to 25 % travel. Frequently travel is outside the local area and overnight. Some of the travel may be international. Education and Experience Bachelor’s degree in life sciences, chemistry, or related discipline required; Ph.D. or advanced degree preferred 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 Extensive experience in commercial manufacturing, product release, regulatory inspections, and third-party quality oversight Strong knowledge of global GMP regulations and industry best practices These positions are eligible for standard Company benefits including medical, dental, vision, time off and 401K, as well as participating in Mineralys incentive plans are contingent on achievement of personal and company performance. Actual compensation may vary from posted hiring range based on geographic location, work experience, education, and/or skill level. US Salary Range: $To Be Posted #LI-Remote

Responsibilities

The Senior Director, Commercial GMP Quality is responsible for leading the development and execution of GMP Quality strategies to support late-stage and commercial manufacturing operations. This role ensures that all products manufactured meet the highest standards of quality and comply with regulatory requirements.