Associate Director Quality Strategies - Clinical Quality

The Role

In this role, reporting to the Director of R&D Clinical Quality, you will: (i)  Serve as a key contributor to Moderna's R&D Quality Function by being an integral part of a highly effective team of GCP quality professionals; (ii) Provide proactive compliance guidance related to global GCP regulations and guidelines through robust Quality Program Management, Issue Management, and CAPA Management; (iii) Conduct audits, investigations, and associated CAPAs, utilizing established knowledge and experience with GCP regulations, guidelines, and local legislation to identify compliance issues in the conduct of clinical trials.  Furthermore, the Associate Director will be responsible for implementing programs and tools that proactively promote adherence to GCP regulations and guidelines. The appointee will also collaborate with study teams and business partners to establish a quality culture within Moderna and achieve a sustained state of inspection readiness.

Here’s What You’ll Do

• Contribute to the development of GCP clinical quality assurance strategies for the support of global clinical trials.

• Enhance the Issue Management and CAPA Management programs to eliminate redundancies and create a more streamlined process.

• Work in conjunction with the Director of R&D Quality on serious breach cases and research scientific misconduct incidents, ensuring that investigations, corrective and preventive actions, and documentation meet regulatory standards and demonstrate appropriate sponsor oversight.

• Plan, conduct, and report on GCP compliance of investigator sites, studies, systems, and vendors as needed, collaborating with Moderna staff to ensure that auditees' proposed corrective actions are suitable and carried out.

• Collaborate closely with members of the Clinical and Research Development teams to facilitate the successful and compliant execution of clinical trials.

• Act as the R&D Quality representative on program teams, offering proactive advice on clinical study matters to help maintain a continuous state of inspection readiness.

• Provide proactive guidance on complex issues to clinical team members.

• Participate in regulatory authority inspections as required and contribute to the preparation and review of responses to inspection findings and questions from regulatory agencies.

• Serve as a trainer and mentor to auditor trainees.

• Participate in compliance projects and initiatives.

• 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 Need (Minimum Qualifications)

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

• 10+ years’ experience in Clinical QA in a global environment.

Here’s What You’ll Bring to the Table (Preferred Qualifications)

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

• Knowledge of relevant FDA, EU, ICH 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. 

• A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.

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, nu