Clinical Quality Director, GCP & GVP

Clinical Quality Director, GCP & GVP
Department: Clinical Operations
Employment Type: Full Time
Location: Cambridge, MA
Description
We are on the lookout for an experienced Clinical Quality Director, GCP & GVP.
In this role you will be part of our Clinical Quality team that focuses on understanding the evolving regulatory landscape to build and enhance fit for purpose quality foundations that enable Good Clinical Practice (GCP) and Good Pharmacovigilance Practices (GVP) excellence. The Clinical Quality team strives to ensure that the Clinical Quality management system (QMS) is optimized to foster a culture where quality innovation that matches company's cutting-edge and patient-centric science.
This is an individual contributor role that will define, implement, and optimize risk-based quality strategy in coordination with the Clinical and the Quality team employing a solution-oriented approach to quality management, quality partnership, quality improvement, and quality excellence.
Joining Merus means joining our pursuit to develop advanced therapies that address unmet needs in cancer treatment. Everything we do contributes to our company's mission: closing in on cancer. The successful candidate will report to the VP of Clinical Operations.
Your role:
As Clinical Quality Director, GCP & GVP you will:

• Define, implement, and optimize risk-based quality management plans for clinical assets.
• Provide global GCP and GVP guidance for cross-functional development teams inclusive of the review of critical documents (e.g., study protocols, investigator's brochure, periodic reports).
• Support issue management and corrective/preventive action management activities within company as well as with external service providers.
• Lead proactive inspection readiness activities globally; Support questions from regulators, review boards, ethics committees, development partners, etc.
• Design and oversee risk-based audit plans which may include but are not limited to clinical investigator audits and vendor audits; Conduct and/or oversee audits in accordance with audits plans.
• Plan and conduct efforts to evaluate and improve the clinical QMS inclusive of reporting to leadership stakeholders (e.g., QMS health metrics, prioritized QMS initiatives, internal audits).
• Partner with functional departments (e.g., Biometrics, Clinical Operations, Clinical Development, Safety) to enhance culture of quality.
• Support efforts to identify and implement new technologies to optimize quality (e.g., electronic QMS, electronic trial master file, clinical trial management system, safety tools, learning management system).
• Lead and support other quality improvement efforts, as support.

Your profile:
Our ideal candidate will have experience with health authority inspection readiness & inspection management. You are a critical problem solver, with proven leadership skills, and an expert in the field of antibody engineering.
This is then backed up by following experience:

• 10 years of GCP and/or GVP quality experience.
• Strong understanding of GCP (e.g., ICH GCP E6 R2; 21 CFR parts 11, 50, 54, 56, 312, 314; European Union Clinical Trials Directive).
• Understanding of GVP (e.g., European Union Directive 2010/84/EU and current modules).
• Understanding of global clinical and safety regulations. As well as the clinical development lifecycle (ideally for cell and/or gene therapies or other advanced therapy medicinal products).
• Experience planning and conducting GCP and/or GVP audits.
• Ability to manage multiple simultaneous projects.
• Commitment to diversity, equity, and inclusion.
• Escalate quality concerns to management / leadership in coordination with Clinical Quality leadership

Benefits
This is a unique opportunity to join a dynamic and innovative team with high visibility. We offer a competitive salary and benefits package, along with a collaborative and stimulating work environment. If you are skilled and motivated, we would love to hear from you!