We are on the lookout for an experienced Clinical Quality professional, GCP.
In this role you will support 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 role that will implement and optimize the 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.
Key Responsibilities
As Clinical Quality Senior Manager/Associate Director, GCP you will:
* 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.
* Participate in GCP inspections by regulatory authorities. Manage 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.
* Develop and implement risk-based audit plans which may include but are not limited to internal audits, clinical investigator audits, system audits, and vendor audits; Conduct and/or oversee audits in accordance with audits plans.
* 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
Your Profile :
Our ideal candidate will have experience conducting and managing GCP/GVP audits and directly supporting Clinical Study Teams.
This is then backed up by following experience:
* 5 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 managing GCP audit programs.
* Ability to effectively escalate quality concerns to Clinical Quality leadership
* Ability to manage multiple simultaneous projects.
* Commitment to diversity, equity, and inclusion.
Our offer :
We offer a once-in-a-lifetime opportunity to work with some of the best and brightest in the biotech industry. As part or Merus, you’ll get to interact with a great international team of people who love what they do! To top it all, we offer a competitive salary, flexible working hours and a company bonus structure. Most importantly, you’ll have the chance to help us close in on cancer – everything you do matters at Merus.
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