MISSION
Mirum Pharmaceuticals is a biopharmaceutical company dedicated to transforming the treatment of rare liver diseases affecting children and adults. Propelled by our passion for patients and their families, we’re focused on turning possibilities into realities. Using data and meaningful evidence, our goal is to transform scientific discoveries into therapies that are poised to positively impact the treatment of rare liver diseases. 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. Learn more about our work, our culture, and what it’s like to be a part of our team: www.mirumpharma.com.
POSITION SUMMARY
Develops, manages, and implements policies and procedures to support international quality assurance activities in compliance with GxP regulatory requirements of the EU and Switzerland. The position requires experience interfacing with global contract manufacturing organizations and knowledge of global GxP regulations. The position is also responsible for the administration of Quality Document (QDOC) and Quality Management Systems (QMS) in Europe.
JOB FUNCTIONS/RESPONSIBILITIES
- Quality Systems
- Responsible for administration of Quality Document (QDOC) and Quality Management Systems (QMS) in Europe
- Assist with the creation, management, and training of local procedures at multiple Mirum Europe locations (France, Switzerland, Netherlands, and Great Britain) and integration with Mirum Global QDOC and QMS
- Support Mirum’s internal and vendor qualification/audit programs
- Contribute to the Global Quality Management Review program
- Establish and oversee the processes for accurately tracking, reporting, and analyzing metrics, as required
- GMP and GDP Operations
- Serve as Qualified Person (Switzerland)
- Release Commercial Finished Drug Product (FDP) batches
- Oversight and support Third-Party Logistics, Serialization, and associated EU Serialization alerts in Europe.
- Manage GMP-impacting quality management systems including Document Control, Change Control, Product Quality Complaints, Deviations and CAPAs
- Update/establish Quality/Technical Agreements with European Distributors and Packaging CMOs
- Qualify customers for distribution of products
- Support PQR review and reporting activities
- Host/manage Switzerland Inspection Readiness activities in support of obtaining a WDA
- Support Mirum subsidiary inspections as needed
- Supervise and train QA staff
QUALIFICATIONS
Education/Experience:
- Bachelor’s degree in a scientific discipline; Master’s degree preferred
- 13+ years’ combined experience in pharmaceutical Quality Assurance and Quality Systems with demonstrated knowledge of cGMP/ICH/FDA/EMA regulations and guidance
- At least 5 years of experience as a Qualified Person (QP) in Switzerland
- Experience with Global process integration
- Experience in Veeva QDOC and Quality Management Systems preferred
- Experience in International product launch preferred
Knowledge, Skills and Abilities:
- Experience in leading Quality System administration and track record of continuous improvement efforts
- Experience with vendor management activities and overall vendor management process
- Demonstrate a quality mindset and ability to influence across the organization
- Successful experience writing and reviewing SOPs and other Quality documents
- Demonstrated ability to successfully interact with regulatory health authorities at inspections and thorough understanding of audit and vendor management programs
- Excellent organizational skills: Proactive management of multiple tasks of varying complexity simultaneously
- Strong interpersonal skills including relationship building, conflict resolution, and verbal/written communications are essential in this collaborative work environment
- Commercial labeling experience and the management of labels is a plus
#LI-REMOTE
Mirum Pharmaceuticals is committed to Equal Employment Opportunity (EEO) and to compliance with all Federal, State and Local laws that prohibit employment discrimination on the basis of race, age, national origin, ethnicity, religion, gender, gender identity, pregnancy, marital status, sexual orientation, citizenship, genetic disposition or characteristics, disability, veteran’s status or any other classification protected by applicable State/Federal/Local laws.
Mirum Pharmaceuticals provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in job application procedures.
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