Senior Manager/Associate Director Clinical Quality, GCP

Senior Manager/Associate Director Clinical Quality, GCP

Apply now
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. 
Please note – we can support this role as a fully remote position – depending on location/state. 

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.   

Apply now

    Our Hiring Process

    Stage 1:

    Internal Review

    This means that we’ve received your application and are in the process of reviewing it.

    Stage 2:

    Initial Call

    We’ll set up a 15-minute phone call with our Internal Recruiter to discuss the details of this job opportunity and your own expectations of the role, as well as Merus as a company.

    Stage 3:

    1st Interview Phase

    During the 1st interview phase, we’ll set up an interview with your potential future manager. We’ll be looking to understand more about your experience, how that fits the role, and what makes you tick.

    Stage 4:

    2nd Interview Phase

    If things are still looking good, we’ll set up several short interviews with team members, peers, Management Team members (where relevant) and HR to make sure we are a good cultural fit. We do our best to plan these interviews on the same day, although on rare occasions they’ll take place on multiple days.

    Stage 5:

    Job Offer

    After positive evaluation from both sides, you will receive our job offer. Once you’ve accepted it, we will draw up the necessary paperwork. You will receive your contract within 3-5 working days and your onboarding process will start!

    Stage 6:

    Welcome

    We’re more than happy to welcome you to join Merus in our pursuit to close in on cancer!

    Related stories

    No items found
    All stories

    Current Opportunities

    0Advanced filters
    Chevron down
    Chevron down
    Chevron down
    All vacancies

    Equal Employment Opportunities

    Merus is an equal employment opportunity employer that does not discriminate on the basis of actual or perceived race, color, religious creed, national origin, sex (including pregnancy, childbirth, and related medical conditions), sexual orientation, age, ancestry, disability or perceived disability, qualified handicap, gender identity, military status, veteran status, certain criminal records, genetic information or testing, HIV testing, or any other characteristic protected by applicable federal, state or local laws (each, a "Protected Characteristic"). We are dedicated to this policy with respect to recruitment, hiring, placement, promotion, transfer, training, compensation, benefits, employee activities and general treatment during employment.

    Fraudulent Recruiting Activities

    Please be cautious of scam recruitment offers claiming to be from Merus. Such scams may come from various sources, including unsolicited email using Gmail of other non-Merus email addresses or via text. These scams seek to obtain personal information or payment from victims by offering jobs that do not exist. If you have been the victim of such a scam, please report it to Internet Crime Complaint Center(IC3) | Home Page if you are living in the US or report it to the police Aangifte of melding doen | politie.nl if you live in the Netherlands.