Associate Director, Investigations Excellence & Inspection Readiness

Moderna Therapeutics; Norwood (MA); On-site; USD 143,000 - 257,000; Full time

Benefits offered by this job

Healthcare

Well-being programs

Family planning benefits

Generous paid time off

Retirement savings plan

Job summary

Moderna Therapeutics in Norwood, MA seeks an Associate Director of Investigations & Operational Performance to strengthen investigation excellence, CAPA effectiveness, and state of inspection readiness across the site. This leadership role partners with Quality, Manufacturing Operations, Logistics, and Strategy to drive systemic improvements.

The role requires a technical degree and 10+ years in biopharma/quality/operational excellence with GMP experience, and a proven record in leading

Qualifications

• Bachelor's degree in a technical discipline required.
• 10+ years biopharmaceutical, manufacturing, quality, or operational excellence experience preferred.
• Experience leading investigations, CAPA, root cause analysis, or operational improvement in GMP environment.

Responsibilities

• Own and improve investigations across the site to drive learning and systemic improvement.
• Lead complex, cross-functional investigations and systemic problem-solving efforts.
• Lead CAPA effectiveness to address systemic issues and reduce risk.
• Partner with operations, quality, and strategy teams to improve reliability and performance.
• Build capability in investigation excellence, root cause analysis, and standardized practices.
• Own site governance processes including Investigation Reviews and CAPA Effectiveness Reviews.
• Use data and trends to identify opportunities for performance improvement and risk reduction.
• Lead the site's continuous Inspection Readiness program with QA alignment.
• Translate regulatory intelligence and inspection trends into proactive readiness actions.
• Develop site-wide inspection capability through assessments and simulations.
• Lead a high-performing team serving as trusted investigators and change agents.

Skills

Investigations leadership

CAPA management

Root cause analysis

Quality systems

Regulatory compliance

Change management

Education

Bachelor's degree in a technical discipline

Job description

The Role:

The Associate Director of Investigations & Operational Performance is responsible for strengthening Norwood's investigation excellence, operational performance, and state of inspection readiness. This leader drives rigorous investigation and systemic problem solving, strengthens CAPA effectiveness, and leads the site's continuous Inspection Readiness program to improve reliability, compliance, and organizational effectiveness across the site. This leader transforms investigations, operational issues, performance trends, regulatory intelligence, and emerging risks into proactive actions and sustainable improvements. The role ensures systemic causes are identified and addressed, recurring issues are prevented, and inspection risks are anticipated and mitigated before they impact site performance or regulatory readiness. Reporting to the Sr. Director of Operations, the Associate Director of Investigations & Operational Performance partners closely with Manufacturing Operations, Logistics, Quality Control, Quality Assurance, Manufacturing Technology & Digital Operations, and Strategy & Intelligent Operations to strengthen quality management systems, improve site performance, and maintain a continuous state of inspection readiness across operations. Success in this role is measured by the site's ability to prevent recurrence, improve operational performance, and sustain inspection readiness through effective investigations, CAPAs, risk management, and proactive identification and remediation of systemic weaknesses.

Here’s What You’ll Do:

• Own and continuously improve the effectiveness, quality, consistency, and rigor of investigations across the site, ensuring investigations drive meaningful learning and systemic improvement and recurrence prevention rather than administrative closure.
• Lead complex, cross-functional investigations and systemic problem-solving efforts that span multiple organizations.
• Lead the site's approach to CAPA effectiveness by ensuring corrective and preventive actions address systemic issues, reduce risk, improve performance, and deliver sustainable results.
• Partner with Manufacturing Operations, Logistics, Manufacturing Support, Quality, Manufacturing Technology & Digital Operations, DNA, and Strategy & Intelligent Operations to improve reliability, prevent recurrence, and strengthen operational performance.
• Build organizational capability in investigation excellence, root cause analysis, and systemic problem solving through coaching, training, mentoring, and standardization of best practices.
• Own and improve site governance processes including Investigation Reviews, CAPA Effectiveness Reviews, Recurrence Reduction Reviews, Site Learning Reviews, Operational Risk Reviews, and Management System Health Reviews.
• Act as a site leader using data, trend analysis, and operational insights to identify opportunities for performance improvement, risk reduction, operational simplification, and increased organizational effectiveness.
• Lead the site's continuous Inspection Readiness program in partnership with Quality Assurance, adapting the program based on regulatory intelligence, site risks, and evolving business needs.
• Translate regulatory intelligence, inspection trends, and site risks into proactive readiness priorities, assessments, and improvement actions that strengthen compliance and reduce inspection risk.
• Build site-wide inspection capability through routine readiness assessments, inspection simulations, coaching, and preparation of leaders and subject matter experts to effectively support regulatory inspections.
• Build and lead a high-performing team capable of serving as trusted advisors, investigators, problem solvers, and change agents across the Norwood organization.

Here’s What You’ll Need:

• Bachelor's degree in a technical discipline.
• 10+ years of biopharmaceutical, manufacturing, quality, technical operations, or operational excellence experience.
• Experience leading investigations, CAPA, root cause analysis, or operational improvement programs in a GMP environment.
• Experience with GMP inspection readiness.
• Direct inspection experience preferred.
• Strong understanding of manufacturing operations, quality systems, and continuous improvement methodologies.
• Proven leadership, stakeholder influence, and change management experience.

Pay & Benefits

The salary range for this role is $142,500.00 - $256,500.00.

• Competitive healthcare, plus voluntary benefit programs to support your unique needs
• A holistic approach to well-being, with access to fitness, mindfulness, and mental health support
• Family planning benefits, including fertility, adoption, and surrogacy support
• Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown
• Savings and investments to help you plan for the future

Our Working Model

As we build our company, we have always believed that an in-person culture is critical to our success. This role is 100% onsite, reflecting the importance of being physically present to support the work, collaborate closely with colleagues, and contribute to our site-based operations. Working onsite enables real-time collaboration, strong team connections, direct mentorship, and the hands-on partnership needed to deliver our mission.

Join us in shaping a world where every interaction is an opportunity to learn, contribute, and make a meaningful impact. Moderna is a smoke-free, alcohol-free, and drug-free work environment.

About Moderna

Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world. By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities. We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S. If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities.

Equal Opportunities

Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, Moderna is an E-Verify Employer in the United States. We consider qualified applicants regardless of criminal histories, consistent with legal requirements.

Accommodations

We’re focused on attracting, retaining, developing, and advancing our employees. By cultivating a workplace that values diverse experiences, backgrounds, and ideas, we create an environment where every employee can contribute their best. Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations team at [e-mail].

Export Control Notice

This position may involve access to technology or data that is subject to U.S. export control laws, including the Export Administration Regulations (EAR). As such, employment is contingent upon the applicant’s ability to access export-controlled information in accordance with U.S. law. Due to the nature of the work and regulatory requirements, only individuals who qualify as U.S. persons (citizens, permanent residents, asylees, or refugees) are eligible for this position. For this role Moderna is unable to sponsor non-U.S. persons to apply for an export control license.

Our Mission and Vision

At Moderna we are pioneering the development of a new class of drugs made of messenger RNA (mRNA). This novel drug platform builds on the discovery that modified mRNA can direct the body’s cellular machinery to produce nearly any protein of interest, from native proteins to antibodies and other entirely novel protein constructs that can have therapeutic activity inside and outside of cells. We have a clear mission to propel the field of mRNA science forward and deliver new medicines to patients and a unique vision for how to achieve this mission.

Our Mission: To deliver on the promise of transformative messenger RNA (mRNA) science to bring new medicines to patients. Our Vision: To unlock the potential of mRNA by establishing an ecosystem of teams and partners that will work together to develop the broadest possible array of drugs, across diverse therapeutic areas and routes of administration, for serious diseases that are not treatable today.