Senior Manager, GCP Quality Assurance

About the Role >>> Senior Manager, GCP Clinical Quality

As the Senior Manager, GCP Clinical Quality reporting to the Senior Director GCP Quality Assurance, you will be partnering with Clinical Development/Operations, Pharmacovigilance and Safety to actively participate in cross-functional study teams to ensure GCP/GVP compliance, assisting in 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 our San Francisco, CA or Cambridge, MA office and requires 2 days a week on site and up to 25% travel.

Your work will primarily encompass:

• Perform 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.
• Provide a support role during regulatory authority inspections and assist with GxP inspection readiness activities.
• Oversee quality aspects related to clinical study start-up, execution, and close-out by providing leadership, guidance, and direction to staff consistent with GCP/GVP.
• Assist in preparation 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.
• Support Quality Management System (QMS) including, but not limited to, the following activities: QA review/approval of deviations, CAPAs, and change controls.
• Draft, review, and approve policies, procedures, and work instructions.

Ideal Candidate Profile >>> Key Requirements

A love of challenging, important work:

We are a pragmatic team, driven to imagine and develop meaningful therapies for improving lives. All employees within our company play a unique and crucial role in our success, both in accomplishing our mission and building a positive company culture. As such, we are looking for someone with the right combination of knowledge, experience, and attributes for this role.

Knowledge:

• Bachelor’s degree in a scientific discipline.
• Strong understanding of clinical trials and pharmacovigilance reporting.
• Strong understanding of FDA, EMA, and ICH Health compliance requirements.
• Understanding of industry quality management tools, quality systems (e.g., QMS, eTMF, EMRs, EDC, etc.).

Experience:

• Minimum of 8 years of relevant experience in Quality Assurance or a 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.
• Experience supporting regulatory agency inspections.
• Experience writing and reviewing SOPs.
• Experience using QMS (Veeva systems preferred).
• Knowledge and experience in Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP) regulations. Preferred Good Laboratory Practice (GLP) experience.

Attributes:

• 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.

Compensation:

• Base pay range: $160,000 - $180,000 annually.
• Total compensation package includes equity, bonus, and benefits.