Manager, Quality Assurance (GCP / GLP)

Location
San Francisco, California
Posted
May 08, 2018
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time

Description

The Manager, QA (GCP/GLP) will be responsible for developing and/or certifying 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) and Good Laboratory Practice (GLP) with assistance in Pharmacovigilance (PV) regulations and guidance

Responsibilities: 

  • Contribute to strategic Clinical QA planning and risk assessment with a focus on post-commercialization activities.
  • Assist in the development of CQA audit plans and implements the actions necessary to ensure processes are conducted in accordance with the audit plan, GCP guidelines and regulatory requirements
  • Ensure all audits are followed-up and corrective actions are completed, implemented, and verified
  • Lead and co-audit US and international sites, internal/external systems and vendors when required
  • Conduct investigations of GCP-related issues (i.e., non-compliance, quality events) and develop corrective 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 with a focus on post-commercialization processes and for all phases of clinical drug development
  • Promote/advance quality awareness throughout the organization; coordinate and provide GCP/GLP/PV training
  • Work in collaboration with clinical sites, Clinical Operations, Clinical Development and Regulatory Affairs and other stakeholders to ensure compliance with GCPs 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 (Protocol, Informed Consent Form, and Trial Master Files)
  • Develop metric reports for CQA management of all issues related to the outcome of the audits
  • Leads and oversee audit consultants

Qualification :  

  • 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/ PV 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