Senior Manager, GxP Training & Compliance

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 Manager, GXP Training and Compliance 

The Senior Manager, GXP Training and Compliance will report to the Director, Quality Systems and lead and manage the daily activities of Veeva Vault Training and overall training program compliance. This role will facilitate new hire onboarding training assignments, maintain organizational training curriculum and personnel training records, monitor training completion, and provide compliance metrics to QA management. 

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

Your work will primarily encompass: 

• Serve as Veeva Vault Training Administrator, facilitating GxP new hire orientation training, curriculum assignment for new/existing GxP employees, and overall GxP training program management. 
• Collaborate with Document Control and GxP department management to assess and implement training requirements for new SOPs.
• Assist with the development of Veeva Vault Training user training materials, including SOPs, and provide technical and training support to users. 
• Assist with the development of New Employee Orientation course content in Veeva and deliver live training as requested by QA management. 
• Establish and maintain employee training files and curriculum records, including on-boarding/off-boarding of employees and consultants. 
• Manage Learner Roles, curriculums, and training requirements in the Learning Management System. 
• Facilitate annual and ad hoc curriculum review with department heads to ensure appropriate assignment of training. 
• Conduct annual training record review to ensure regulatory compliance and inspection readiness. 
• Coordinate and facilitate Annual GxP Training requirements. 
• Compile and report training compliance metrics for management review. 
• Partner with IT to support Veeva system change control activities for system process enhancements/improvements and new release validation. 
• Serve as backup Veeva Quality Docs Document Administrator and support document control functions as needed. 
• Perform other duties and complete special projects 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: 

• Bachelor’s Degree or higher in a scientific discipline is required. 
• Experience in managing and maintaining GxP and corporate training programs, and Document Control systems. 
• Strong knowledge of GxP/FDA regulations and experience in supporting regulatory inspections. 

Experience: 

• 8+ years of industry experience. 
• 2+ years as Veeva Vault Training Administrator.  
• Experience in managing and maintaining GxP and corporate training programs, and Document Control systems. 
• Experience establishing effective KPIs for training. 
• Experience creating and facilitating training for Quality Systems. 

Attributes: 

• Strong written and verbal communication and interpersonal skills. 
• Commitment to supporting internal and external teams and customers. 
• Demonstrates strong autonomy and initiative. 
• Meticulous attention to detail and well organized. 
• Ability to multi-task, shift priorities, work in a fast-paced environment, and adeptly solve problems. 
• Effectively collaborate as a team player in a highly matrixed organization, demonstrating professional demeanor, enthusiasm, and self-motivation. 

The base pay range for this position is expected to be $180,000 - $190,000 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.