Job Description

About the Role

Senior Manager, GCP Clinical Quality reporting to the Director GCP Quality, you will partner with Clinical Development/Operations, Pharmacovigilance and Safety to actively participate in cross-functional study teams to ensure GCP/GVP compliance, assist in identifying and communicating clinical trialrelated risks and opportunities for process improvement as well as reviewing/approving studyrelated documents and plans and supporting audits.

This hybrid role is based out of our San Francisco, CA or Cambridge, MA office requires 2 days a week on site and up to 25% travel.

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 followup 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 startup, execution, and closeout 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 crossfunctional study teams
• Continue to improve/refine Olemas riskbased GCP compliance approach globally
• 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

Ideal Candidate Profile

Key Requirements

Knowledge:

• Bachelors degree in 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

• 8 plus 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 riskbased audit plans.
• Demonstrated ability to develop and foster positive, collaborative relationships with internal staff as well as with external, thirdparty 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. In addition, preferred Good Laboratory Practice (GLP) experience.

Attributes

• Excellent verbal and written communication skills.
• Ability to work independently and collaboratively, as required, in a fastpaced, matrixed, team environment consisting of internal and external team members.
• Analytical thinker with excellent problemsolving 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 handson and be a strong individual contributor

The base pay range for this position is expected to be $ 160,000 $185,000 annually, however the base pay offered may vary depending on location, market, job related knowledge, skills and capabilities, and experience. The total compensation package for this position also includes equity, bonus, and benefits.

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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 Olemas official email addresses end in @olema.com. Our official corporate website is olevama.com; our careers page is olevama.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 paymentsof any kind, and does not make job offers without an inperson interview.

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 longterm careers. A Summary of Benefits is available for all applicants.

Please note: Olema doesnt accept agency resumes and is not responsible for any fees related to unsolicited resumes. Thank you.

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