Associate Director, Quality Strategies

**The Role**:
Reporting to the Sr. Director of Quality Strategies, R&D Quality (RDQ), located at the Moderna Office in Melbourne, Australia, the Associate Director, Quality Strategies, will be a key contributor in growing and shaping Moderna’s global R&D Quality Program (GCP/GLP/GVP/CSV) in the APAC region. Primarily focusing on Clinical Quality, the Associate Director will contribute to building R&D Quality’s presence in the region, aid in the establishment and execution of Quality Strategies and Plans in support of Moderna’s R&D activities in the region, support local/regional Health Authorities Inspections (e.g., TGA, PMDA, etc.) and provide regional oversight of the R&D Quality audit program (e.g., Site/Study/Vendor/Process Audits) partnering with RDQ Program Leads. This role will also support the other R&D Quality GxP disciplines (GVP, GLP, and CSV) including proactive Quality support, identification and conduct of audits, support of Health Authority Inspections and contributions to Regulatory Intelligence activities. The appointee will proactively partner with local R&D operational functions and 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 R&D Quality strategies for the support of global R&D activities in the region.

Proactively partner with members of the regional Research and Development organizations to support the successful and compliant execution of R&D activities within the region.

Develop and/or provide input in the development of RDQ Quality Audit Schedules and Annual Audit Plans.

Provide strategic direction for the regional program for audits (e.g., Site/Study/Vendor/Process Audits) that integrates into the global R&D Quality program and manage the program utilizing an innovative, risk-based approach.

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.

Proactively identify and report systematic issues as well as opportunities for process improvements.

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

Participate in Regulatory Authority inspections (GCP, GVP, GLP) within the region including inspection preparation training and support; actively support during the inspection and provide input and review of responses to inspection observations and regulatory agency questions resulting from inspections.

Contribute to the R&D Quality Regulatory Intelligence program

Contribute to the R&D Quality Newsletter

Participate in compliance projects and initiatives.

Serve as a trainer and mentor to junior auditors.

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 Clinical QA in a global environment.

Strong knowledge of relevant GCP regulations, guidelines and local/regional legislation.

Working knowledge of relevant GVP regulations, guidelines and local/regional legislation is preferred.

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.

Moderna offers personalized benefit programs and well-being resources as unique as our global workforce so employees can do their best work.

We recognize and appreciate your diverse needs and interests and do our best to support you at work and at home with:
Quality healthcare and insurance benefits
Lifestyle Spending Accounts to create your own pathway to well-being
Free premium access to fitness, nutrition, and mindfulness classes
Family planning and adoption benefits
Generous paid time off, including vacation, bank holidays, volunteer days, sabbatical, and a discretionary winter break
Educational resources
Savings and investments
Location-specific perks