Associate Director, GCP Quality Assurance

Olema Oncology•Boston, MA

6d•$190,000 - $210,000•Hybrid

About The Position

As the Associate Director, GCP Quality Assurance, reporting to the Senior Director GCP Quality Assurance, you will be partnering with Clinical Development/Operations, Pharmacovigilance and Safety in cross-functional study teams to drive GCP/GVP compliance. This will include identifying and communicating clinical trial-related risks and opportunities for process improvement, as well as reviewing / approving study-related documents and plans and supporting audits. This hybrid role is based out of either our San Francisco, CA or Cambridge, MA office and requires up to 20% travel.

Requirements

Bachelor’s Degree or higher in a scientific discipline
Strong understanding of clinical trials and pharmacovigilance reporting
In-depth knowledge of and ability to interpret and apply GCP, EU, FDA, and ICH regulations and guidelines
Understanding of industry quality management tools, quality systems (e.g., QMS, eTMF, EMRs, EDC, etc.)
A minimum of 8 years of relevant experience in Quality Assurance or related role in a pharmaceutical, biotechnology, or related environment
Demonstrated experience leading and/or conducting internal and external QA audits developing and executing risk-based audit plans
Demonstrated ability to develop and foster positive, collaborative relationships with internal staff as well as with external, third-party vendors
Hands-on experience with regulatory inspections and inspection readiness activities
Experience writing and reviewing SOPs
Experience using QMS (Veeva systems preferred)
Knowledge and experience in Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP) regulations. In addition, preferred Good Laboratory Practice (GLP) experience
Ability to interpret and apply GCP, EU, FDA, and ICH regulations and guidelines
Excellent verbal and written communication skills
Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members
Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines
Excellent planning, organization, and time management skills including the ability to support and prioritize multiple projects
Ability to work hands-on and be a strong individual contributor

Responsibilities

Performs internal and external audits as assigned to ensure compliance with GCP/GVP regulations and guidelines
Provide GCP/GVP auditing activities, including audit preparation, execution, report preparation, and follow-up to any findings/observations, including corrective and preventive actions (CAPAs), communicate audit results to internal stakeholders
Partner with QA leadership during regulatory authority inspections and drive GxP inspection readiness activities
Oversees quality aspects related to clinical study start-up, execution, and close-out by providing leadership, guidance, and direction to staff consistent with GCP/GVP
Prepare for health authority inspections, suppliers and or clinical sites
Oversee clinical compliance and quality within the context of cross-functional study teams
Continue to improve/refine Olema’s risk-based GCP compliance approach globally
Manage Quality Management System (QMS) including, but not be limited to, the following activities: QA review/approval of deviations, CAPAs and change controls
Draft, review, and approve policies, procedures, and work instructions