Mirum develops patient-inspired therapies for rare disease, advancing medicines where unmet need is greatest. Mirum is relentlessly rare. Learn more. Backed by NEA.
About the role
The VP, Global GMP Quality position will be responsible for leading the GMP quality functional teams at Mirum and its subsidiaries (US and International). This position will play a pivotal role in steering the organization toward an ongoing commitment to quality improvement, driving efforts to identify areas for optimization, innovation, and excellence. Found on 1752vc Careers, the job board for startup and VC roles.
What they're looking for
- Bachelor’s degree in biochemistry, chemistry, biology, or other science related field (Advanced degree preferred)
- 15+ years of progressive Quality Assurance experience in pharmaceutical and/or Biotech industries, with at least 10+ years in quality leadership role and/or people management including direct & indirect reports
- Demonstrates extensive knowledge of cGMP manufacturing and Quality Management in compliance with FDA (CBER and/or CDER) and EMA requirements for global-regulated products
- Demonstrates extensive knowledge of the development and commercialization of medical device in compliance with FDA 21CFR820, ISO13485 and EMA MDR regulations
- Comprehensive knowledge of GMP, GDP, ISO, ICH, and global regulatory requirements
- Product lifecycle including Late-stage drug development, Regulatory (NDA, MAA, BLA, etc) submission and commercial manufacturing experience
More about this role
Mirum Pharmaceuticals is a biopharmaceutical company dedicated to transforming the treatment of rare diseases. We are passionate about advancing scientific discoveries to become important medicines for rare disease patients. We are collaborative, creative, and experienced professionals and we’re looking to augment our team with other individuals who embody our values: care, be real, get it done, and have fun, seriously.
The VP, Global GMP Quality position will be responsible for leading the GMP quality functional teams at Mirum and its subsidiaries (US and International). This position will play a pivotal role in steering the organization toward an ongoing commitment to quality improvement, driving efforts to identify areas for optimization, innovation, and excellence. This person will be responsible for managing, mentoring and supporting a GMP Operations team of clinical and commercial Quality Assurance (QA) and Quality Control (QC) professionals. This person will provide leadership and hands-on support to ensure the seamless execution of GMP QA and QC functions, including product quality complaint investigation, root-cause investigations, and the reporting of critical GMP issues...
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