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The Role
Reporting to the Associate Director of R&D Quality, the Senior Manager of R&D Quality 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 Senior 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 Senior Manager will be responsible for establishing and maintaining the clinical process audit program. The Senior 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
Here’s What You’ll Bring to the Table
BS/BA, MS or PhD and a minimum of 10, 8, 6 years’ experience, respectively, in Biotech, Pharma or Clinical Research Organization.
Preferred Qualifications (qualifications particular to the role)
Working knowledge of relevant Good Clinical Practices (GCP) and applicable regulations/guidelines. (e.g. ICH E6, 21 CFR Parts 50, 54, 56, and 312).
Working knowledge of combination products and medical device regulations/legislation (including but not limited to ISO 14155, ISO 13485, applicable FDA and EU regulations including MDR)
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.
Travel Requirements 30%
Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:
About Moderna
In over 10 years since its inception, Moderna has transformed from a research-stage company advancing programs in the field of messenger RNA (mRNA), to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across seven modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for rapid clinical and commercial production at scale. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. Most recently, Moderna’s capabilities have come together to allow the authorized use and approval of one of the earliest and most effective vaccines against the COVID-19 pandemic.
Moderna’s mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and autoimmune diseases. Moderna has been named a top biopharmaceutical employer by Science for the past seven years. To learn more, visit (url removed).
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.
Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is an E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.
Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. We’re focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to contribute their best.
Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the Talent Acquisition Partner or contact the Accommodations team at (url removed). (EEO/AAP Employer)
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