Associate Director, GMP 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 >>> Associate Director, GMP Quality Assurance  

As the Associate Director, GMP Quality Assurance, reporting to the Head of Quality Assurance, you will support the assurance of product quality throughout Olema’s Clinical development projects through to Commercial launch. This role will initially focus on oversight of clinical phase contract manufacturing, particularly in support of clinical supplies. It will later focus on compliance of commercial networks, handling of product complaints, annual product review and assurance of commercial supply. You will develop and maintain relationships with our CMOs and distribution networks as well as internal CMC and Clinical Supply Chain groups. You will also partner with our Clinical Operations groups to ensure consistent supplies reaching Clinical pharmacies. 

This role is based out of our San Francisco, CA or Cambridge, MA office and will require 10-15% travel. 

What You Will Do:  

• Collaborate with operational counterparts and the Regulatory Team to set GMP compliance and operational strategy, ensuring that Regulatory is engaged in both process and jurisdictional changes
• Provide day to day GMP QA support for review of Master Production Records, Executed Batch Records, Specifications, and Certificates of Analysis / Compliance
• Review key documents such as Technology Transfer reports, Process and Performance Qualification, Method Validation, Cleaning Validation and Stability Studies 
• Be an integral part of the selection, qualification, and maintenance of our Contract Service Providers for Manufacturing and Analytical Testing 
• Issue Supplier Corrective Action Reports (SCARs) against CMOs  
• Process any Contract Service Providers Vendor Change Notifications (VCNs) within Olema’s Quality Management System 
• Establish and periodically review Quality Agreements with the company’s Contract Service Providers 
• Develop, track, and trend GMP Quality Metrics for product quality and compliance 
• Partner with GCP Quality Assurance and Pharmacovigilance to ensure compliance with international regulations
• Conduct Annual Product Quality Reviews 
• Conduct vendor audits as required 

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: 

• Bachelors Degree in a scientific field is required; Master’s degree preferred 
• Experience with oversight of clinical and commercial production 
• Familiarity with domestic and international compliance requirements (U.S., Canada, Europe, APAC, LATAM)  
• Specific knowledge of 21 CFR Parts 11 / 210 / 211, EudraLex Volume 4, WHO regulations regarding GMPs and GDPs 
• Familiarity with Process Performance Qualification, Hold Time Studies, Cleaning Validation 

Experience: 

• 8+ years of relevant experience in the biopharmaceutical industry 
• 5+ years direct GMP oversight in a Quality organization 
• Experience overseeing, partnering, and auditing CMOs for Oral Solid Dosage DP, packaging / labeling / kitting, and distribution for both Clinical and Commercial 
• Inspection management experience preferred 
• Veeva familiarity preferred 

Attributes: 

• A risk-based approach to compliance coupled with commitment to product SISPQ 
• Demonstrated ability to work in a dynamically changing and highly cross-functional environment
• Ability to handle diverse workloads and capable of completing tasks with little or no supervision
• Ability to prioritize workload in order to facilitate meaningful, timely outcomes  
• Excellent project management and organization skills

The base pay range for this position is expected to be $180,000 - $195,000 USD 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.