Senior Manager, Quality Document Control and Compliance

Olema Oncology is dedicated to developing better medicines for breast cancer and beyond. Our lead program, palazestrant (OP-1250), is a complete estrogen receptor antagonist (CERAN) currently in development for metastatic breast cancer with blockbuster potential as a monotherapy and in combination in ER+/HER2- metastatic breast cancer. Our follow-on product candidate, OP-3136, is a potent KAT6 inhibitor with best-in-class potential.  

Our scientific breakthroughs are accelerated through the ways in which we fearlessly support, motivate, and challenge one another. At Olema, we know that when we put people first, our work becomes second to none. If you’re ready to join us at the edge of something unstoppable, let’s make a profound impact together for our patients, for your career, for what’s beyond. 

You can view our latest corporate deck and other presentations here.

About the Role >>> Senior Manager, Quality Document Control and Compliance 

The Senior Manager, Quality Document Control and Compliance will report to the Director, Quality Systems and lead and manage the daily activities of Veeva Vault QDocs and overall document management process and compliance. This role includes but not limited to: creation and processing of document change control documentation in Veeva QDocs, management of standard operating procedures (SOPs) and other GXP documentation, GXP record processing and archival, maintain document control compliance KPIs and compile and report metrics for management review. 

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

Your work will primarily encompass: 

• Serving as Veeva Vault QDocs Administrator and document control manager  
• Processing document change control (DCC) in Veeva for GxP controlled documents
• Formatting the finalized documents to ensure compliance with effective templates 
• Performing proof reading and finalize document for final processing in Veeva QDocs 
• Developing, updating, managing, and maintaining GxP controlled documents in close cooperation with functional area representatives  
• Developing SOPs and WIs to support Quality Systems and Veeva Document control processes 
• Assisting and training end users in Veeva to execute document review, approval and troubleshoot as needed 
• Maintaining document control compliance KPIs such as periodic review and compiling and reporting metrics for management review. 
• Partnering with IT to support Veeva system change control activities for system process enhancements/improvements and new release validation. 
• Serving as backup Veeva Quality Training Administrator and supporting creation of training assignments as needed
• Performing 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 is required
• Experience in managing and maintaining GxP compliance documents 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 QDocs Administrator
• Experience in managing and maintaining GxP documents and Document Control systems
• Experience establishing effective KPIs for document management system
• 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 $150,000 - $160,000 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. 

#LI-CK1

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.

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 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 payments of any kind, and does not make job offers without an in-person interview.