- Define, implement, and optimize risk-based quality management plans for clinical assets.
- Provide global GCP guidance for cross-functional development teams in order to build robust internal processes that ensure GCP/GVP compliant Sponsor oversight of the conduct of clinical trials. Partner with functional departments (e.g., Biometrics, Clinical Operations, Clinical Development, Safety) to enhance culture of quality.
- Host GCP inspections by regulatory authorities. Lead proactive GCP inspection readiness activities globally; Support questions from regulators, review boards, ethics committees, development partners, etc.
- Support issue management and corrective/preventive action management activities within company and with external service providers.
- Design and oversee risk-based audit plans which may include but are not limited to internal audits, clinical investigator audits, file audits, system 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).
- Support efforts to identify and implement new technologies to optimize quality (e.g., electronic trial master file safety tools).
- Instill a culture for cross-functional review, ownership, management and filing of all documentation (internal and external) within the eTMF that is supportive of a clinical trial
- 15 years of GCP 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) is a plus.
- Understanding of global clinical and safety regulations. As well as the clinical development lifecycle, ideally for large molecules.
- Experience organizing and overseeing GCP audit programs.
- Ability to effectively escalate quality concerns to management / leadership in coordination with Clinical Quality leadership
- Ability to manage multiple simultaneous projects.
- Commitment to diversity, equity, and inclusion.
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Senior Director Clinical Quality, GCP - Cambridge, United States - Merus
Description
Senior Director Clinical Quality, GCPApplication Deadline: 21 June 2024
Department: Clinical Operations
Employment Type: Full Time
Location: Cambridge, MA
Description
We are on the lookout for an experienced Clinical Quality Director, GCP.
In this role you will set up and lead the 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) excellence. The Clinical Quality team strives to ensure that the clinical quality management system (QMS) is optimized to foster a culture where quality innovation matches the company's cutting-edge and patient-centric science.
This is a strategic 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.
Your role:
As Clinical Quality Director, GCP you will:
Our ideal candidate will have experience with hosting GCP health authority inspections (for marketing authorization) & leading the inspection readiness activities that ensure successful outcome of such inspections.
This is then backed up by following experience:
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.
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
