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

Has overall responsibility for maintaining Mirum’s GxP Training programs and serves as the Compliance Wire/eLMS Business Owner. This includes the day-to-day management of the eLMS and content administration of the eLMS for GxP Training. Responsible for the creation and management of GxP Training curricula, Annual GxP training, and the creation and delivery of training materials for Mirum’s eLMS. Assists as a back up for Document Control utilizing the EDMS system.

JOB FUNCTIONS/RESPONSIBILITIES

• Provides Quality oversite for the company’s GxP QA Training Program.
• Creates, manages, and administers the process for GxP training in the eLMS, and conducts routine tasks, as needed.
• Manages staff/contractors who administer GxP Training updates and enhancements.
• Defines the business requirements to develop, implement, and improve the eLMS system, and the overall company GxP training program.
• Assigns and updates eLMS training curricula.
• Works closely with IT, and key software experts, to create and execute system enhancements to the eLMS GxP Training Program.
• Works with functional managers to create and implement eLMS functionality, training, curricula, and metadata fields, to meet user needs.
• Works closely with managers to maintain inspection ready GxP training records.
• Establishes and creates reports to regularly manage GxP Training assignments.
• Provides day-to-day eLMS and overall training assistance for existing users.
• Creates training material, and training videos, for the GxP Training Program.
• Supports process owners, and other company training managers, by proving consultation on training delivery and processes.
• Works closely with IT to evaluate, test, and validate ongoing system updates, to maintain the GxP Training Program through IT change control.
• Acts as the company’s onsite Subject Matter Expert, and Business Owner, for the GxP Training Program for all regulatory inspections and other audits.
• Coordinates and executes Training Record Audits per SOPs (CV, JD, and GxP Training curriculum).
• Assist with day-to-day Document Control activities utilizing the Veeva Quality Docs platform.

QUALIFICATIONS

Education/Experience:

• Bachelor’s degree in a scientific discipline
• 6 years’ experience and strong background in Quality and GxP Training and Document Control in the drug development industry with knowledge of cGMP/ICH/FDA/EMA regulations
• Prior experience in QA with particular focus on working with electronic learning management systems and electronic document management systems.

Knowledge, Skills and Abilities:

• 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 and written communication are essential in this collaborative work environment
• Experience with ComplianceWire and Veeva platforms is strongly preferred

#LI-HYBRID

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.

**For US Applicants Only: Mirum Pharmaceuticals is also committed to the safety and wellbeing of all who work with us. As we continue to monitor the COVID-19 pandemic, Mirum Pharmaceuticals has made the decision to require all perspective candidates and independent contractors in the United States to be fully vaccinated against the COVID-19 virus. To be considered fully vaccinated is to have both doses of a two-dose vaccine two weeks apart or two weeks since a single-dose vaccine has been administered. This does not apply to candidates/independent contractors who are granted an accommodation/exemption by Mirum Pharmaceuticals based on qualifying religious or medical reasons.

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