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.

 

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. That’s why our benefits and well-being resources are designed to support you—at 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 $142,500.00 - $256,500.00. 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 individual’s 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.