Senior Manager - Associate Director, Clinical Quality - GCP

2 days ago

Apply Now

Receive Emails with Similar Jobs

Merus N.V.

WebsiteLinkedInAll Job Openings

immuno-oncology • oncology • immunology • antibody engineering • antibody discovery

201 - 500

Description

• 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.

Requirements

• 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. • 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.

Benefits

• 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.