Mirum focuses on finding and developing drugs for difficult-to-treat liver diseases. Our programs are focused on cholestatic liver disease in children and adults. Our drug candidates, maralixibat and volixibat, target the bile acid accumulation from cholestasis, and we believe our approach can address the underlying cause of symptoms, liver damage, and clinical outcomes. Our goal is to give families their lives back.
The Associate Director of GMP Quality will be responsible for managing activities involving GMP operations and compliance with Mirum procedures and applicable regulatory requirements; development and implementation of policies and procedures to ensure quality standards in compliance with relevant regulatory and quality guidelines. This position requires experience with providing quality oversite for global contract manufacturing organizations (CMO) and Contract Testing Labs (CTL) as well as knowledge of global GMP regulations for clinical and commercial products.
- Provide QA oversite of CMO manufacturing Drug substance, drug product, and finished product for commercial and clinical use.
- Author and negotiate quality agreements for GxP vendors.
- Review and approve protocols and reports related to technology transfers, process validation, and development activities.
- Works closely with the CMO to investigate, document, and resolve compliance issues and deviations. Ensure deviations are thoroughly identified, defined, and properly assessed.
- Perform or support vendor audits and write audit reports with findings, when necessary.
- Review and approve master batch records and executed batch records and perform batch disposition for drug substance, drug product, and finished product for commercial and clinical use.
- Develop, track and trend quality metrics for reporting to Quality Management Review and Annual Product Review.
- Work with CMO to support PAI readiness.
- Perform gap analysis and identify resolution and implement to ensure compliance.
- Review and approval of analytical methods, product specifications, and product certificate of analysis.
- Review and approve protocols and reports related to technology transfer, process validations, method transfer, method qualification and/or validation, expiry dating, etc.
- Develop and approve Quality Systems documents (procedures, specifications, protocols, deviations, change controls, CAPAs, etc.)
- Investigate, manage and approve product complaint reports for closure.
- Communicates manufacturing deficiencies and non-conformances to management and works with vendors to ensure timely resolutions.
- Author quality sections to support annual product quality review.
- Stay abreast of changes in applicable FDA and European regulations, directives, and guidelines, and determine potential impact on company GMP activities.
- Review and support regulatory and quality documents (INDs, IMPDs,) submissions
- Interface with European Qualified Person to ensure timely release of product and GMP Certifications or Declarations.
- Assists in hosting audits and regulatory inspections.
- Maintain flexibility to perform other/additional tasks as assigned.
- Must be capable and willing to travel (up to 15%), including international travel.
- Bachelor’s Degree in a scientific discipline.
- 15+ years of experience in the pharmaceutical industry, including 10+ years in GMP Quality Assurance with progressive responsibilities.
- Knowledge and demonstrated experience in the applicable GMP regulations, FDA Regulations and Good Manufacturing Practices, EMA Eudralex Regulations, ICH Guidelines and Good Distribution Practices.
- Strong verbal and written communication.
- Strong influencing skills: proven ability to get things done.
- Ability to work effectively with cross-functional teams.
- Late-stage drug development and commercialization, Regulatory (NDA) submission and commercial manufacturing experience.
- Experience with inspection readiness processes and ability to drive continuous improvement.
To apply, please send your resume to firstname.lastname@example.org.