Manager, Clinical Quality Assurance

Quality South San Francisco, California


Description

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Manager, Clinical Quality Assurance

 

Requisition ID: 337

 

Position Summary

The Manager, Clinical Quality Assurance will be responsible for developing and/or approving clinical quality systems/procedures and ensuring quality oversight. Responsibilities will cover all aspects of clinical and nonclinical studies and will require a focus on Good Clinical Practice (GCP), Good Laboratory Practice (GLP) and Good Pharmacovigilance Practices (GVP) regulations and guidance.

 

Responsibilities

  • Contribute to strategic Clinical QA planning and risk assessment
  • Lead and co-audit GCP/GLP/PVG compliance audits, including clinical investigator sites, contract research organizations (CROs) and contract clinical laboratories to determine compliance status and identify compliance risks
  • Assist in the development of CQA audit plans (internal and external) and implements the actions necessary to ensure processes are conducted in accordance with the audit plan, GCP/GLP/GVP guidelines and regulatory requirements
  • Ensure all audits are followed-up and corrective actions are completed, implemented, and verified
  • Conduct investigations of GCP-related issues (i.e., non-compliance, quality events) and work with subject matter experts to develop corrective and preventative action plans
  • Assist in developing or overseeing CQA quality systems and support department infrastructure development; assist with creation/revision of appropriate CQA SOPs
  • Provide GCP guidance to internal departments for all phases of clinical drug development
  • Promote/advance quality awareness throughout the organization; coordinate and provide GCP/GLP/GVP training
  • Work in collaboration with clinical sites, Clinical Operations, Clinical Development, Pharmacovigilance, and Regulatory Affairs and other stakeholders to ensure compliance with GxPs and to maintain inspection readiness; attend study management team meetings, as assigned
  • Review regulatory submission documents (Clinical Study Report and Integrated Safety/Efficacy Summaries) and other essential documents (protocols, informed consents, investigator brochure, and study plans)
  • Develop metric reports for CQA management of all issues related to audit results and other clinical compliance issues
  • Manage audit consultants
  • Performs other duties as assigned 

 

Qualifications

  • Minimum BA/BS degree preferably in biological sciences, pharmacy, or related field
  • 6 years of pharmaceutical experience, preferably in Quality Assurance or a clinical setting and 3+ years direct US and international Clinical QA auditing experience, preferably familiar with GLP/ GPV QA
  • Excellent working knowledge of GCP-related requirements, proficiency with regulatory and ICH guidelines
  • Broad experience in the pharmaceutical industry with a strong clinical development background
  • Detail oriented with Quality Assurance and/or Clinical Development background with analytical and problem solving skills
  • Ability to analyze and reconcile moderate-to-complex GCP compliance issues independently and in a group setting
  • Ability to travel 30% of time, or as required

 

Portola Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, protected veteran status, or any characteristic protected by law.