Associate Director, R&D Quality

The Role:
Reporting to the Sr. Director of Clinical Quality Assurance (Clinical QA), R&D Quality, located at the Moderna Headquarters in Cambridge, MA, the Associate Director, Clinical QA, will be a key contributor, growing and shaping Moderna’s GCP audit program. The Associate Director, will contribute to building a highly functioning team of GCP auditors, aid in the establishment of Annual Audit Plans in support of Moderna’s clinical trial activities, ensuring compliance with Health Authorities Regulations (e.g., FDA, EMA, etc.) and will be responsible for management of an audit program (e.g., Site/Study Audits, Systems Audits). The appointee will 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 organizations to support the successful and compliant execution of clinical trials.

• Develop and/or provide input in the development of Annual Audit Plans and study-specific audit plans.

• Lead complex audits including planning, execution and reporting, and provide guidance to Moderna staff to ensure the proposed corrective actions received from the auditees are appropriate.

• Provide leadership to interdisciplinary audit teams for complex systems/process audits.

• Identify and report systematic issues beyond the individual audit findings as well as opportunities for process improvements.

• Independently perform all activities including audit preparation, conduct, presentation, and timely reporting of audit findings, and evaluation of CAPAs.

• Present observations to auditees and prepare a written audit report.

• Participate in post-audit meetings to discuss unresolved issues with Senior Management.

• Manage for cause, critical and/or complex quality issues independently.

• Provide education, guidance and/or training for GCP functional areas and clinical operations teams.

• Participate in regulatory authority inspections, as necessary, including support prior to and during the inspection, and provide input and review of responses to inspection observations and regulatory agency questions resulting from inspections.

• Participate in compliance projects and initiatives.

• Serve as a trainer and mentor to junior auditors.

• Participate in developing a program for audits (e.g., Site/Study audits, System/Process audits) and manage the program utilizing an innovative, risk-based approach.

• Contribute to the continuing development of a quality culture at Moderna.

Here’s What You’ll Bring to the Table:

• BS/BA, MS or PhD and a minimum of 12, 10, 9 years’ experience, respectively, in Biotech, Pharma or Clinical Research Organization.

• 10+ years experience in a Clinical QA in an international environment.

• Strong knowledge of relevant FDA, EU, ICH GCP guidelines, and GCP regulations.

• Knowledge of relevant FDA, EU, ICH Pharmacovigilance guidelines and regulations an advantage.

• Experience working with CROs, vendors, and relationship management preferred.

• Excellent auditing skills and ability to communicate significant observations to Principal Investigators, Senior Scientists, etc., in a sound and factual manner.

• Strong interpersonal skills and ability to provide training and mentoring to auditor trainees and junior staff.

• Strong leadership skills with ability to effectively organize and execute tasks.

• Ability to work both independently and in a team environment.

• Excellent analytical, problem solving and decision-making skills in a complex, fast-paced, and changing environment.

• Excellent communication and presentation skills, both verbal and written.

• Ability to influence and negotiate effective solutions, excellent interpersonal skills.

• Ability to manage multiple projects in a fast-paced environment.

• Ability to collaborate effectively in a dynamic, cross-functional matrix environment.

Here’s What We’ll Bring to the Table:

• On-site subsidized cafeteria or catered lunches
• Company-provided iPhone
• Free parking, monthly subway pass or a subsidized commuter rail pass
• Free annual corporate membership to Bluebikes
• Highly competitive healthcare coverage including: medical offered through BCBS (HMO/PPO), dental, and vision offered through VSP
• Flexible Spending Accounts for medical expenses and dependent care expenses
• 16 weeks of 100% paid parental leave for all new parents
• 16 weeks 100% paid family caregiver leave
• 20 weeks 100% paid medical leave
• Eligible for “Moderna Month” (one month paid sabbatical after five years of service and eligible for additional one month paid sabbatical every 3 years thereafter)
• Adoption assistance and discounts to local childcare centers, as well as access to care.com
• 401k (traditional and Roth offered) with 50% match on first 6% deferred. Match is vested immediately
• A suite of Moderna paid insurance coverage, including: life insurance, short-term and long-term disability
• Voluntary legal assistance plan
• 15 days’ vacation and 7 sick days per year, in addition to a discretionary winter shut down and 11 company paid holidays (includes 2 floating holidays)

Candidates should be aware that Moderna currently maintains a policy requiring all US-based employees to be fully vaccinated against COVID-19. Newly hired employees must be vaccinated prior to their employment start date. Moderna is an equal opportunity employer and will provide a reasonable accommodation to those unable to be vaccinated where it is not an undue hardship to the company to do so as provided under federal, state, and local law.

About Moderna

In 10 years since its inception, Moderna has transformed from a science 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 six modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for both clinical and commercial production at scale and at unprecedented speed. 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 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 auto-immune 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.