Associate Director, GCP Quality Assurance

Olema Oncology • Boston, MA

5d • $190,000 - $210,000 • Hybrid

About The Position

Olema Oncology is dedicated to developing better medicines for breast cancer and beyond. Our lead program, palazestrant (OP-1250), is a complete estrogen receptor antagonist (CERAN) currently in development for metastatic breast cancer with blockbuster potential as a monotherapy and in combination in ER+/HER2- metastatic breast cancer. Our follow-on product candidate, OP-3136, is a potent KAT6 inhibitor with best-in-class potential. Our scientific breakthroughs are accelerated through the ways in which we fearlessly support, motivate, and challenge one another. At Olema, we know that when we put people first, our work becomes second to none. If you’re ready to join us at the edge of something unstoppable, let’s make a profound impact together for our patients, for your career, for what’s beyond . You can view our latest corporate deck and other presentations here . About the Role >>> Associate Director, GCP Quality Assurance 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.
• 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

Nice To Haves

• In addition, preferred Good Laboratory Practice (GLP) experience

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

Benefits

• We offer a competitive compensation and benefits package
• seeking to provide an open, flexible, and friendly work environment to empower employees and provide them with a platform to develop their long-term careers.
• A Summary of Benefits is available for all applicants.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 11-50 employees