About the position
Are you ready to make a real difference in patients’ lives and thrive in a fast-paced team-oriented environment? At Maze Therapeutics, we’re on a mission to revolutionize healthcare through the power of human genetics, and we’re looking for a highly motivated Associate Director of Clinical Quality Assurance (QA) to join our team. In this pivotal role, you’ll ensure the quality and compliance of our clinical development pipeline and studies. Reporting to the Director of QA, you’ll have a direct impact on the success of our clinical programs and the design of the Maze Good Clinical Practice (GCP) compliance program. You will identify and escalate compliance issues, enable decision-making, and drive the development and execution of effective and comprehensive action plans to mitigate clinical quality and compliance risks. Additionally, you will lead the development and management of our quality management system providing oversight related to GCP activities while representing Quality on Clinical Development teams.
Responsibilities
- Partner and develop strong relationships with Clinical Operations and Clinical Sciences personnel across development teams and provide coaching and strategic compliance guidance.
- Serve as the Clinical Quality lead on clinical study teams and provide leadership and direction to Clinical Operations and Development stakeholders on GCP related activities/issues.
- Act as a GCP expert and consultant for Clinical Operations colleagues.
- Collaborate with stakeholders to assess clinical trial risks, identify study priorities, track compliance metrics, identify high-risk vendors, and define key compliance activities.
- Develop and maintain relationships with CRO Quality teams to ensure ongoing review of quality and compliance issues.
- Support vendor management, evaluation, and qualification of GCP service providers.
- Implement and support Maze Quality Systems and Cross functional SOP development, and lead quality clinical study oversight processes.
- Understand organizational changing needs, and complete ongoing gap analyses, enable process development, and lead best practice opportunities inclusive of standard operating procedures (SOP’s), and templates to be consistent with current ICH/GCP principles.
- Identify and escalate significant quality and compliance issues to the Head of Clinical Operations and Head of Quality Assurance.
- Provide guidance and support during and following internal audits and external regulatory inspections.
- Lead inspection readiness activities in Clinical Development.
- Conduct training sessions for Maze staff, as needed.
Requirements
- Bachelor’s degree in a scientific discipline with 8 + years of relevant experience in pharmaceutical quality assurance and compliance.
- Proven expertise in implementing and managing quality systems.
- Thorough knowledge and understanding of drug development and the clinical trial process.
- In-depth knowledge of current regulatory and ICH GCP requirements, with experience in international regulations, guidelines, and standards. (GLP knowledge is a plus).
- Ability to engage and influence key stakeholders at all levels to drive compliance and quality outcomes.
- Exceptional attention to detail, with the ability to work independently, within cross-functional teams, and alongside external partners and vendors.
- Ability to set priorities, manage timelines, work with minimal supervision in a fast-paced environment.
- Willingness to travel for critical on-site activities and relevant QA or vendor oversight activities.
Benefits
- Competitive medical, dental, and vision insurance
- Mental health offerings
- Equity incentive plan
- 401(k) program with employer match
- Generous holiday and PTO policy
