The Role
The Manager of R&D Quality & Compliance will proactively promote compliance to Good Clinical Practice (GCP) regulations by providing Clinical and Research Development teams compliance guidance support related to GCP global regulations and guidelines. Additionally, the Manager applies established knowledge and experience with GCP regulations, guidelines and local legislation to the auditing process to identify compliance issues associated with the conduct of clinical trials. The Manager should have a solid knowledge of US FDA and international regulations, and of ICH guidelines. The appointee will also be responsible to partner with study teams to create a quality culture within Moderna and help reach a sustained state of inspection readiness.
Here’s What You’ll Do
- Participate in the development of clinical quality assurance strategies for the support of global clinical trials.
- Partner closely with members of the Clinical and Research Development groups to support the successful and compliant execution of clinical trials.
- Work closely with clinical study team members to provide proactive guidance to complex issues.
- Provide input in the development of the Annual Audit Plan and create and maintain study-specific audit plans.
- Plan, execute and report GCP investigator site, study, system/process, and vendor audits, as necessary, and work with Moderna staff to ensure the proposed corrective and preventative actions received from the auditees are appropriate and implemented.
- Participate in post-audit meetings to present/discuss audit findings.
- Identify and report systematic issues and areas for improvement with the assistance of management, as needed.
- Participate in regulatory authority inspections, as necessary.
- Serve as a trainer and mentor to auditor trainees.
- Contribute in the continuing development of a quality culture at Moderna.
- Additional duties as may be assigned from time to time.
- Approximately 30% travel.
Here’s What You’ll Need (Minimum Qualifications)
- BS/BA, or MS and a minimum of 10 or 5 years experience, respectively, in Biotech, Pharma, Medical Device, or Clinical Research Organization.
Here’s What You’ll Bring to the Table (Preferred Qualifications)
- Working knowledge of relevant Good Clinical Practices (GCP) and applicable regulations/guidelines. (e.g. ICH E6, 21 CFR Parts 50, 54, 56, and 312).
- Experience working with CROs, vendors, and relationship management preferred.
- Prior experience managing individuals preferred.
- Vaccine clinical trials experience is a plus.
- Excellent auditing skills and ability to communicate significant observations to Auditees in a sound and factual manner.
- Ability to manage multiple projects in a fast-paced environment.
- Ability to collaborate effectively in a dynamic, cross-functional matrix environment.
- Ability to work independently and within a team environment.
- Strong communication and presentation skills, verbal and written.
- Ability to influence and negotiate effective solutions.
- Strong interpersonal skills and ability to provide training and mentoring to auditor trainees and junior staff.
- A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.
About Moderna
Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world.
Moderna is a smoke-free, alcohol-free and drug-free work environment.
Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply!
Moderna is proud to be an equal opportunity workplace and is an affirmative action employer.
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