Associate Director, Investigations Excellence & Inspection Readiness

The Role:

The Associate Director of Investigations & Operational Performance is responsible for strengthening Norwoods investigation excellence operational performance and state of inspection readiness. This leader drives rigorous investigation and systemic problem solving strengthens CAPA effectiveness and leads the sites 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 sites 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.

Heres What Youll 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 sites 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 sites 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.
  

Heres What Youll Need:

• Bachelors 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.

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.

Pay & Benefits

At Moderna we believe that when you feel your best you can do your best work. Thats why our benefits and well-being resources are designed to support youat work at home and everywhere in between.

• 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
• Location-specific perks and extras

The salary range for this role is $142500.00 - $256500.00. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An individuals position within the salary range will be based on several factors including but not limited to specific competencies relevant education qualifications certifications experience skills performance and business or organizational needs. The successful candidate may be eligible for an annual discretionary bonus other incentive compensation or equity award subject to company plan eligibility criteria and individual performance.

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 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 persons 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 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 please apply!

Moderna is an E-Verify Employer in the United States. We consider qualified applicants regardless of criminal histories consistent with legal requirements.

Accommodations

Were 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 .

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 applicants 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.

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Required Experience:

Director