Sr. Manager, R&D Quality, Clinical Quality
Located in Cambridge, MA and 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 should have a solid knowledge of medical device and combination products, 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 with a focus on combination products/medical devices.
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.
Perform other tasks as assigned by line manager.
Contribute in the continuing development of a quality culture at Moderna.
Here’s What You’ll Bring to the Table:
BS/BA, or MS and a minimum of 10 or 5 years experience, respectively, in Biotech, Pharma, Medical Device, or Clinical Research Organization.
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.
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.
Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:
- Highly competitive and inclusive medical, dental and vision coverage options
- Flexible Spending Accounts for medical expenses and dependent care expenses
- Lifestyle Spending Account funds to help you engage in personal enrichment and self-care activities
- Family care benefits, including subsidized back-up care options and on-demand tutoring
- Free premium access to fitness, nutrition, and mindfulness classes
- Exclusive preferred pricing on Peloton fitness equipment
- Adoption and family-planning benefits
- Dedicated care coordination support for our LGBTQ+ community
- Generous paid time off, including:
• Vacation, sick time and holidays
• Volunteer time to participate within your community
• Discretionary winter shut down
• Paid sabbatical after 5 years; every 3 years thereafter
- Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents
- 401k match and Financial Planning tools
- Moderna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit options
- Complimentary concierge service including home services research, travel booking, and entertainment requests
- Free parking or subsidized commuter passes
- Location-specific perks and extras!
Candidates should be aware that Moderna currently maintains a policy requiring all US-based employees to be fully vaccinated against COVID-19 and receive a booster shot once eligible. Newly hired employees must be vaccinated and boosted prior to their employment start date. Moderna is an equal opportunity employer and will provide a reasonable accommodation to those unable to be vaccinated or receive a booster where it is not an undue hardship to the company to do so as provided under federal, state, and local law.
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 www.modernatx.com.
Moderna is a smoke-free, alcohol-free and drug-free work environment.
Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.#LI-LG1