Associate Director, Quality Assurance (GCP/GLP)

Mirum focuses on finding and developing drugs for difficult to treat liver diseases.  Our lead program is focused on two severe liver diseases in children, Alagille Syndrome and progressive familial intrahepatic cholestasis (PFIC).  Both conditions can result in severe itching, liver damage and a need for liver transplant.  Based on a wealth of data from clinical trials spanning multiple years and involving more than one hundred patients, we believe our approach can address the underlying cause of symptoms and liver damage.  Our goal is to give families their lives back.

POSITION SUMMARY:

This position reports to the Senior Director of QA. The primary responsibilities will be to ensure quality and compliance of GCP, GLP and GLP-like activities with respect to Standard Operating Procedures, applicable regulatory requirements (FDA, EU, ICH & country specific), and current industry standards and practices.

PRIMARY RESPONSIBILITIES:

  • Coordinate, schedule and prepare for reviews, inspections, and audits (internal and external) in accordance with established GLP/GCP QA objectives.
  • Effectively conduct internal and external audits and communicate the results of those audits to the required internal and external parties.
  • Perform Quality Assurance reviews of GLP and regulated clinical study protocols, analytical test methods, method validation protocols and reports, instrument qualifications, software validations and standard operating procedures.
  • Develop and implement the QA compliance program for the qualification and compliance inspection of CROs and contract testing laboratories that are performing clinical and nonclinical quality assurance activities.
  • Schedule and perform facility-wide and system audits with respect to the portion of the facility and systems related to GLP and GLP-like activities
  • Maintain and update the CAPA system for deviations related to GCP/GLP and GLP-like activities
  • Maintain a copy of the Audit Master Schedule and update inspections, audits and reviews in the tracking spreadsheet
  • Assist in inspection readiness activities and support Regulatory Agency Inspections focused on the areas of GCP, GLP and GLP-like activities
  • Maintain working knowledge of FDA, EU and other global regulations and guidance governing Good Laboratory Practice (GLP) activities
  • Perform GLP/GCP Compliance training for new hired-individuals, as necessary, and refresher training on an annual basis for all individuals engaged in the conduct of clinical and nonclinical studies.

QUALIFICATIONS:

  • Bachelors or advance degree in science major or related discipline is required with a minimum of 8 years of experience in a pharmaceutical/biotechnology industry.
  • At least 5 years of experience in Quality Assurance are required, preferably in an environment that covered both GCP/GLP and non-GLP regulated laboratory activities; experience in GMP a bonus.
  • Familiar with GCP audits
  • Experience developing and establishing GCP/GLP SOPs for compliance, including necessary training.
  • Experience with CRO management, including establishment of quality agreements and support of audits and remediation.
  • Experience with review of GCP data, clinical study protocols, and summary reports associated with regulatory filings.
  • Ability to support all required activities for regulatory inspection readiness.
  • Knowledge of IRB / EC oversight and requirements.
  • Familiarity with Trial Master Files (TMF).
  • Bioanalytical testing, Pharmacokinetic (PK) analysis to support non-clinical and regulated clinical studies.
  • Toxicokinetic (TK) analysis to support GLP nonclinical studies.
  • Good working knowledge of FDA regulatory requirements and implementation.
  • Thorough understanding of Phase I – IV Clinical Trials.
  • Demonstrated experience with analytical instrument IQ/OQ/PQ and Computer System Validation.
  • Effective communication skills (verbal and written).
  • Strong interpersonal skills, team player, and flexible without compromising quality.
  • Ability to manage multiple projects in a dynamic environment.

KNOWLEDGE, SKILLS & ABILITIES

  • Safety database experience required; Argus preferred
  • Proficient in MS Word, Excel, PowerPoint, Outlook and other applicable business software tools.
  • Detailed knowledge of relevant US, EU and ICH guidelines, initiatives and regulations governing both clinical studies and post-approval safety.
  • Ability to travel both domestically and internationally (<10%)
  • Proficient in MS Word, Excel, PowerPoint, Outlook and other applicable business software tools.

WORK ENVIRONMENT

  • This is a high growth, fast paced small organization. The ability to be productive and successful in a work environment is critical.

Please submit your resume to careers@mirumpharma.com

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