Senior Manager, GCP Quality Assurance

About the role

The Senior Manager, GCP Clinical Quality reports to the Senior Director GCP Quality Assurance. This hybrid role is based out of our San Francisco, CA or Cambridge, MA office requiring 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 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
• Avoid oversight of 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 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
• Minimum of 8 years of relevant experience in Quality Assurance or related role in a pharmaceutical, biotechnology, or related environment
• 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.)
• 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. 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 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

Pay

The base pay range for this position is expected to be $160,000 - $180,000 annually, however the base pay offered may vary depending on location, market, job related knowledge, skills and capabilities, and experience.

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.

Equal Opportunity Employer

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.

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 accept agency resumes and is not responsible for any fees related to unsolicited resumes. Thank you.