Director, GLP Quality Assurance

The Opportunity:

• The Director, Good Laboratory Practice Quality Assurance (GLP QA) is responsible for ensuring Good Laboratory Practices (GLP) compliance at RevMed and external vendors contracted to perform regulated work on behalf of RevMed including all GLP vendors.

• Responsibilities include research laboratory vendors that perform work to support regulated clinical studies.

• Develops the annual vendor audit plan.

• The Director GLP QA performs and/or manages vendor audits including:

  • Development of the audit plan, audit conduct, and reporting

  • Tracking and coordination of audit closure tasks including review of observation responses from vendor(s) in conjunction with operational subject matter experts (SMEs), as applicable.

  • Provision of vendor approval recommendations

  • Maintenance of vendor approval status in Veeva.

  • Development and/or review of Quality Agreements

• Performs or participates in internal audits.

• Provides QA review of CRO study protocols and reports for compliance utilizing a risk-based approach, as needed and serves as an advisor to the Nonclinical Development and Clinical Pharmacology (NDCP) to resolve compliance issues.

• Monitors vendor QA units for compliance with applicable regulations including review of vendor study specific QA audit reports.

• Advises Sponsor(s) on compliance requirements for test and control article used in GLP studies.

• Liaises and/or consults with GLP vendor QA departments on study-related issues such as deviations, investigations, CAPAs and other compliance issues.

• Provides annual GLP training or liaises with an external trainer to provide GLP training to RevMed functional team(s).

• Attends functional area meetings (e.g., NDCP and Biomarker group) to discuss and review new or on-going issues, projects, and/or studies.

• Works with QA management for resource planning, as needed.

• Attends periodic clinical QA group meetings, as needed.

• Provides periodic quality and compliance updates to QA management.

• Develops/prepares standard operating procedure (SOPs) content to GLP audits, and reviews functional area and QA SOPs for GLP compliance.

• Provides consultative QA guidance for computerized system vendors (and systems) supporting GLP studies.

Required Skills, Experience and Education:

• Bachelor’s or Master’s Degree.

• 12+ years of experience in global Good Laboratory Practice (GLP) Quality Assurance (QA).

• Extensive audit and inspection management experience.

Preferred Skills:

• Registered Quality Assurance Professional – Good Laboratory Practice (RQAP-GLP).

• Planning and scheduling expertise.

• Experienced in effective prioritization of competing initiatives and tasks across multiple projects.

• Ability to communicate effecttively with senior leadership, management and cross functional teams.

• Ability to manage workstreams to maintain delivery timelines through disciplined planning, tracking and follow-up.

• Ability to balance detail-oriented execution with strategic oversight.

• Experienced with the proactive identification, assessment and mitigation of risks and with timely issue escalation, as applicable.

• Regulatory expertise with at least the following regulations and guidance:

  • 21CFR Part 58 Good Laboratory Practice.

  • 21 CFR Part 11 Electronic Records; Electronic Signatures.

  • OECD #1 – 24 Standards and Advisory Documents on Good Laboratory Practices.

  • ICH E6 (R2 and R3) Good Clinical Practices.

  • Japanese Ministry of Health Labor and Welfare (MHLW) – Good Laboratory Practice.

  • Applicable US and EU guidance documents including bioanalytical, in vitro and in vivo genetic, Phototox, and hERG toxicology studies.

• Experience with the following audit types

• Testing facilities.

• Bioanalytical and PK data analysis Labs.

• hERG and Phototoxicity testing facilities.

• Archives – biorepositories, paper and electronic data storage.

• Computer Systems Validation.

• Biomarker Labs (including Artificial Intelligence and Machine Learning).

• Central Laboratories.

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