Senior Manager, GCP Quality Assurance

About the role

The Senior Manager, GCP Clinical Quality reports to the Senior Director GCP Quality Assurance. You will partner with Clinical Development/Operations, Pharmacovigilance and Safety to ensure GCP/GVP compliance, identify and communicate clinical trial-related risks and opportunities for process improvement, and review/study-related documents and plans. You will also support audits, regulatory inspections, and the Quality Management System (QMS).

Responsibilities

• 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
• Support 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
• Avoid oversight of clinical compliance and quality within the context of cross-functional study teams
• Support 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

Requirements

• A love of challenging, important work
• A minimum of 8 years of relevant experience in Quality Assurance or related role in a pharmaceutical, biotechnology, or related environment
• Develop and execute risk-based audit plans
• Develop and foster positive, collaborative relationships with internal staff as well as with external, third-party vendors
• Support regulatory agency inspections
• Write and review SOPs
• Experience using QMS (Veeva systems preferred)
• Knowledge and experience in Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP) regulations

Preferred Candidate Profile

• Excellent verbal and written communication skills
• 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

Pay Range

The base pay range for this position is expected to be $160,000 - $180,000 annually.

Important Information

• We provide equal opportunity to all employees and applicants for employment and believe that great ideas and discoveries come from a mix of expertise, background, and experience.
• Olema is building a culture where the value of difference is celebrated. 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.
• Please note: Olema doesn’t accept agency resumes and is not responsible for any fees related to unsolicited resumes.
• Fraud Alert: We are aware of employment scams where individuals pose as representatives of Olema Oncology and make false use of our company name to defraud job seekers. To protect yourself, please note that Olema’s official email addresses end in @olema.com. Our official corporate website is olema.com; our careers page is olema.com/careers; our LinkedIn page is linkedin.com/company/olema-oncology . Please visit these links for official information from Olema.
• Communication from any other variant is fraudulent. Olema does not conduct interviews via text message/messaging platforms, will not ask you to download anything as part of your interview, will never request any form of payment, provide upfront payments of any kind, and does not make job offers without an in-person interview.