Senior Director, GCP/GVP Quality Assurance

Olema Oncology is a cancer medicines company dedicated to impacting breast cancer and beyond. Our lead program, palazestrant (OP-1250), is a differentiated oral medicine known as a complete estrogen receptor antagonist (CERAN) initially in development for metastatic breast cancer. Our pipeline also includes OP-3136, a potent, selective oral inhibitor of the KAT6 pathway. At Olema, we are building a focused team committed to our mission with intention and clarity. Working alongside a talented passionate group of leaders and advisors, we strive to create better medicines that aim to help patients feel better, longer. For more information, visit us at www.olema.com.

About the Role >>> Senior Director, Quality Assurance – GCP/ GVP 

The Senior Director of Quality Assurance – GCP/GVP will have the overall accountability and responsibility for providing oversight across GLP, GCP and GVP functions, quality management systems and practices at the company. The individual will partner with Research, Clinical Development, Clinical Operations, Drug Safety and Regulatory Affairs functions to drive compliance with global regulatory requirements and company policies to safeguard the integrity of clinical trials and data. This individual will also be responsible for integrating Quality Risk Management, track, and monitor Key Performance Indicators (KPIs), and drive continuous improvement by partnering with respective functions within Olema. The individual will ensure alignment of Corporate and Quality goals and associated deliverables.  

Job Responsibilities: 

• Quality Oversight: Provide quality oversight to ensure that GLP, clinical and safety activities are conducted in compliance with applicable regulations (e.g., FDA, EMA, ICH E6 R2/R3) and company policies. Serve as the primary point of contact for GLP/GCP/GVP quality matters and provide guidance to internal and external stakeholders and provide oversight of audits for Clinical Sites, Vendors, and GXP Systems, identifying risks and developing robust risk-mitigation strategies to ensure compliance with regulations
• Compliance: Oversight of development of appropriate policies and procedures to ensure compliance with health authority regulations and guidelines. Author, review and approve Quality documents, as needed
• Quality Management System (QMS): Provide oversight and partner with the QMS lead on the implementation and functioning of the GLP, GCP and GVP Quality Management System. Lead continuous improvement initiatives to enhance the quality management system. Oversee and continually improve cross-functional quality systems (e.g., vendor management, deviations, CAPA etc.) to ensure compliance
• Quality Risk Management: Determine and develop an audit plan for GLP, GCP and GVP vendors/clinical sites. In collaboration with the functions, track and trend compliance, identify gaps, and implement risk mitigation strategies for Olema sponsored clinical trials
• Key Performance Indicators (KPIs): Establish, monitor, and report on KPIs related to Quality across partnering functions
• Submissions Related: Accountable for Quality review of non-clinical and clinical trial documentation, and documents submitted to regulatory agencies
• Quality Strategy: Develop and execute the quality management strategy for GLP, GCP and GVP to support Olema’s clinical pipeline and commercial activities. Provide strategic direction and collaborate with cross-functional partners to ensure quality standards are integrated into clinical and safety operations and processes 
• Cross-Functional Collaboration: Collaborate with cross-functional teams, (e.g., Research, Clinical Development, Clinical Operations, Regulatory Affairs, and Pharmacovigilance), to ensure alignment on quality-related issues, risk assessments and mitigations 
• Oversight of External Partners: Work with functional partners to ensure the oversight of Contract Research Organizations (CROs) and other external vendors/partners. Ensure proper qualifications and oversight of vendors and service providers
• Health Authority Inspections: Establish and train cross-functional teams on Inspection readiness. Leads the coordination, management of Olema inspections by health authority (e.g., PV, BIMO inspections) or partner for GLP, GCP and/or GVP activities in collaboration with respective functions
• People Management: Build, develop and coach the Quality team members. Assign work and review performance to direct reports 
• Communication: Proactively monitor for quality issues, identify and escalate critical issues in a timely manner, and develop robust mitigation strategies

Ideal Candidate Profile >>>  

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 is required, preferably in a scientific field; advanced degree is a plus 
• Demonstrated knowledge of US and other major global (ICH, EU, Asian) regulatory compliance requirements 
• Advanced knowledge of Quality Assurance principles, concepts, industry practices and standards 

Experience: 

• 15+ years of drug development, including 10+ years of quality assurance experience in the Biotech/Pharmaceutical industry 
• Minimum 7 years of experience in GxP Quality role, with 3+ years in people and team management 
• Minimum of 5+ years’ experience hosting regulatory BIMO inspections (e.g., FDA, EMA, PMDA) and managing GCP audit programs
• Strong proven hands-on experiences with GLP, GCP, and GPV compliance matters, and contractor management in the bio/pharma industry 
• Experience handling FDA and other Regulatory Health Authority inspections and interactions 

Attributes:  

• Pragmatic and analytical with an ability to deal with complex issues and be solution oriented  
• Strong business acumen and ability to successfully work with international and cross functional partners  
• Proven ability to deliver on goals within a cross-functional team/partnership environment with a high level of professionalism 
• Excellent verbal, written and communication skills 
• Excellent project management and organizational skills
• Must be able to effectively collaborate with peers and be comfortable working in a matrixed team
• Flexible, able to be successful in a past paced, lightly structured environment 

Requirements: 

• This position is hybrid and requires on-site presence at our Offices in Cambridge or San Francisco for a minimum of 2 days per week  
• Domestic and/or international travel is required (15%-20%)  

The base pay range for this position is expected to be $260,000 - $275,000 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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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. Thank you.

Additional Note/Fraud Alert:  Olema will not conduct interviews via text message or messaging platforms and will not ask you to download anything as part of your interview.  Though we use third party tools to help with advertising our jobs, please be vigilant in checking that the communication is in fact coming from Olema.