Associate Director, GMP Quality
Mirum Pharmaceuticals
Zug, CH
vor 8 Std.

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.

POSTION SUMMARY

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 product.

*This position will be based in the Zug Facility.

JOB FUNCTIONS/RESPONSIBILITIES

  • Provide QA oversite of CMO manufacturing Drug substance, drug product, finished product and distribution for commercial and clinical use including Distributors.
  • Ensure that the Packaging and Labelling activities has been performed as per the defined steps in the batch record in accordance with current GMP Guidelines
  • Be part of the application process to the relevant regions and be named on all licences being applied for as applicable.
  • 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 QMR and APR.
  • 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, advise, review and approve Quality Systems documents (procedures, specifications, protocols, deviations, change controls, CAPAs, etc.)
  • Investigate, manage and approve product complaints reports for timely closure.
  • Communicates manufacturing deficiencies and non-conformances to management and works with vendors to ensure timely resolutions.
  • Support authoring and reviewing of 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.
  • Host audits and regulatory inspections
  • Maintain flexibility to perform other / additional tasks as assigned.
  • Must be capable and willing to travel (up to 20%), including international travel.

 

 

QUALIFICATIONS (Education/Experience):

  • 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/GDP 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 process and able to provide drive its continuous improvement

 

#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.

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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