About the Role >>> Sr. Manager Quality Systems

As the Sr. Manager, Quality Systems reporting to the Director Quality GMP you will implement, manage and improve GXP Quality Management Systems per regulatory requirements and guidelines to support Olema’s Phase 3 clinical programs. This position will collaborate with other GXP functional departments (CMC, Clinical Operations, Supply Chain and Regulatory) to implement phase appropriate Quality System processes at Olema.

This role is based out of our San Francisco (preferred) or Cambridge, MA office and will require up to 5% travel.

Your work will primarily encompass:

• Implementing and managing the electronic Quality management processes (eQMS) including document control, GXP training program, audit, change control, deviation/CAPA management and vendor management modules, to support Phase 3 clinical programs
• Liaising between QA, Regulatory, GXP operations (CMC & Clinical), and IT in defining, implementation and management of eQMS systems
• Collaborating with IT and operations for QMS process/system enhancements and process improvements
• Authoring, reviewing and approving policies, procedures, and other related documents for the Quality systems processes at Olema
• Escalating Quality systems related issues to management for timely mitigation and closure
• Supporting creation of training materials and employee training execution for Quality systems
• Supplying Quality system support during regulatory inspections with document retrieval functions, inspection logistics oversight and other support as needed
• Maintaining and managing audit (external and internal) documentation at Olema
• Maintaining and managing Olema’s vendor management process and documentation
• Acting as an SME for electronic Quality management systems
• Creating and delivering QMS key performance and quality matrices to QA leadership and Executive management
• Communicating and promoting of a culture of quality and operational excellence at Olema

Ideal Candidate Profile >>> Experienced Sr. Manager Quality Systems

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 with 8+ years relevant work experience or MS with 6+ years relevant work experience in the pharmaceutical industry
• 21CFR part 11, GXP, ICH, EU and global compendia regulations and guidelines
• Working knowledge of GXP business processes and process improvement
• Lean Six Sigma principles and methodologies (preferred)
• Veeva Quality Suite a plus

Experience:

• eQMS implementation
• Preparation and administration of QMS training programs
• Experienced interfacing with external software vendors
• Experienced in managing projects towards process improvements

Attributes:

• Excellent attention to detail
• Excellent written and oral communication skills
• Self-starter who thrives in a fast-paced environment
• Positive attitude
• Best work done as part of a team

The base pay range for this position is expected to be $169,000 - $184,000 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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