Clinical Trials Quality Assurance Expert
2 weeks ago
The Role
Are you passionate about transforming the lives of patients through innovative cancer treatment?
We are looking for a highly motivated Senior Manager with at least 5 years of experience within GCP and/or GCLP to safeguard patients and ensure quality compliance in all aspects within GCP.
As a QA Senior Manager, you will have in-depth and strong scientific expertise within quality assurance and all regulatory requirements related to clinical development.
Key responsibilities include:
- Planning, conducting, and reporting quality audits within the GCP regulated areas.
- Mentoring QA colleagues and experienced Lead auditors to increase the competency level across the global QA GCP & PV team.
- Developing and maintaining the audit strategies in collaboration with the Team Lead.
- Coordinating and leading GCP inspection readiness activities for FDA, EMA, and PMDA inspections.
- Participating in inspections and audits performed by our partners.
- Driving the development, maintenance, and improvement of the Genmab QMS with focus on GCP and GCLP requirements.
- Conducting and coordinating internal GCP training.
- Delivering GCP advisory expertise within the company and to external vendors.
Requirements include:
- MSc in Natural Science or similar and at least 5 years of profound experience within GCP and GCLP.
- Experienced Lead Auditor within GCP and/or GCLP with in-depth knowledge related to internal process audits and CRO audits of clinical data processing in different IT systems.
- Practical proficiency in the use and understanding of Veeva Vault QMS.
- Experience with the due diligence process and qualification of new vendors or services.
- Considered a Domain Expert within GCP and/or GCLP by peers with a strong interest and ability to educate others.
Personal requirements include:
- Strong analytical skills with an eye for detail combined with the ability to extract and apply into a tactical and strategic context.
- Ability to strive and thrive in a setting with multiple complex tasks and shifting priorities.
- Pro-active and open-minded, a dedicated team player with excellent oral and written communication skills.
This role can be located in Copenhagen, Denmark, Utrecht, the Netherlands, or Princeton, New Jersey, U.S.
The role is hybrid, with an expectation of 60% on-site presence, combined with the option to work remotely two days per week on average.
About Us
- We are a global biotechnology company focused on developing innovative cancer treatments.
- We are passionate about our purpose and genuinely care about our mission to transform the lives of patients.
- We bring rigor and excellence to all that we do.
- We are a generous collaborator who can work in teams with diverse backgrounds.
- We are determined to do and be our best and take pride in enabling the best work of others on the team.
- We are not afraid to grapple with the unknown and be innovative.
- We work hard and are not afraid to have a little fun while we do so.
Locations
We leverage the effectiveness of an agile working environment for the betterment of employee work-life balance.
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