Manager, Quality GMP
About The Position
Mineralys Therapeutics is a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities such as chronic kidney disease (CKD), obstructive sleep apnea (OSA) and other diseases driven by dysregulated aldosterone. Its initial product candidate, lorundrostat, is a proprietary, orally administered, highly selective aldosterone synthase inhibitor. Mineralys is headquartered in Radnor, Pennsylvania. For more information, please visit https://mineralystx.com. Follow Mineralys on LinkedIn, Twitter and Bluesky Mineralys is a fully remote company. The GMP Quality Manager is responsible for overseeing all Quality Management System (QMS) activities within a Good Manufacturing Practice (GMP)–regulated environment. This role ensures that manufacturing, testing, packaging, and distribution activities comply with applicable regulatory requirements (FDA, EMA, ICH, etc.). The GMP Quality Manager supports GMP leadership in quality assurance, drives continuous improvement, and supports successful GMP inspections and audits.
Requirements
- Bachelor’s degree in life sciences, Engineering, Pharmacy or related discipline
- 5–8+ years of QA experience in biotech/pharmaceutical environment; experience in small biotech strongly preferred.
- Knowledge of GMP and working familiarity with GCP; GLP experience is a plus.
- Ability to work independently in a fast-moving, resource-lean environment.
- Ability to interpret global regulatory expectations (FDA, EMA, ICH).
- Prior involvement in inspection readiness or regulatory submissions.
Responsibilities
- Batch Review & Product Release
- Oversee review and approval of batch records, analytical data, and supporting documentation.
- Ensure timely disposition of materials, intermediates, and finished products.
- Support investigations of out-of-specification (OOS), out-of-trend (OOT), and deviation events.
- Vendor and Site Oversight
- Support qualification, periodic review, and auditing of GMP vendors.
- Review vendor and site quality issues, change control, deviations, and CAPAs.
- Audit & Inspection Readiness
- Support the planning, conduct, and follow up on internal GMP audits and GMP external vendor audits.
- Review audit schedules, reports, and CAPA tracking.
- Training & SOP Oversight
- Support the development and maintenance of GMP training programs for employees.
- Support the development, review and maintenance of SOPs.
- Quality Management System
- Support the development, implementation, and maintenance of the Quality Management System (QMS).
- Ensure compliance with GMP regulations, internal procedures, and industry standards.
- Manage document control, change control, deviation investigations, CAPAs, and product release processes.
- Track and analyze quality metrics to identify trends and opportunities for improvement.
- Continuous Improvement
- Lead quality improvement initiatives to enhance compliance, efficiency, and product quality.
- Implement risk management tools (e.g., FMEA, risk assessments) to support sound decision-making.
Benefits
- 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.
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What This Job Offers
Job Type
Full-time
Career Level
Manager
Number of Employees
51-100 employees
