Job Description

The Role:
Reporting to the Sr Director, Global Quality Compliance, the Director of the Global Audit Program will be responsible for global quality audit program. The individual will be responsible for developing, approving, monitoring, and maintaining the global audit schedule for all Moderna manufactures, entities, service providers and suppliers. Additionally, the individual we ensure a robust audit process is established that is risk based and predicative in identifying compliance risk.

The individual will ensure comprehensive practices are implemented across Moderna’s global quality compliance program that will certify audit outcomes, responses and associated CAPA’s. In collaboration with the key stakeholders, the team will implement and a establish a life cycle of continuous improvement. The individual will also maintain a certified auditor program.

The successful candidate must have experience in a biotech or pharmaceutical development environment and knowledge of cGMP quality systems. This position will be located in Norwood, MA.

Here’s What You’ll Do:
Manage all aspects of the audit lifecycle: scheduling, planning, issuing agendas, executing, issuing reports, evaluating responses, requesting clarification, issuing CAPA, and closing

Incorporate sound risk management principles for the establishment of the annual audit schedule.

Develop and maintain updates to annual global audit schedule

Ensure that the audit agenda is risk-based and has the appropriate internal and/or external subject matter experts as part of the audit team.

Perform internal audits for Moderna affiliates and sites

Work directly with auditees to ensure completion of correct CAPA to address compliance concerns identified during audits

Identify compliance risks and escalate issues to appropriate levels of management for resolution

Develop and report trends based on internal / external regulatory observations to better focus the scope of audits

Manage auditors that support the audit program and ensure that they have the required skills, training and procedural qualification requirements

Drive consistency with audit report observation classification, status and overall risk

Participate in the development, implementation and maintenance of procedures and templates to assist the evaluation and audit process

Assist with the development and manage the auditor qualification, training requirements and develop effective auditing tools

Create, publish, and maintain metrics that measure the health and effectiveness of the audit program

Identify and drive program improvements.

Here’s What You’ll Bring to the Table:
Bachelor degree, preferably in Sciences or Engineering with applied Quality industry experience. BS with 8-10 years of experience or MS with 5-8 years experience in a pharmaceutical or biotechnology company.

Exceptional knowledge in product regulatory requirements

In-depth working knowledge of US and worldwide GxP regulations

Ability to build positive relationships to foster a collaborative approach to proactive compliance activities

Ability to prioritize multiple priorities, projects, and team members, as well as adapt to changing business needs

Excellent communication skills; including technical writing and presentation skills

Demonstrated teamwork and mediation skills; ability to work through conflicting situations

Ability to broker a strategic position after taking feedback from multiple sources

Experience driving decision making

Ability to succinctly communicate level of risk, priority, or impact to the business

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 and extras!

The benefits offered may vary depending on the nature of your employment with Moderna and the country where you work.

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 www.modernatx.com .

Moderna is a smoke-free, alcohol-free and drug-free work environment.

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