Associate Director, Investigations Excellence & Inspection Readiness

Moderna; Norwood (MA); In loco; USD 143.000 - 257.000; Tempo pieno

Vantaggi offerti da questo lavoro

Healthcare benefits

Fitness & well-being programs

Family planning support

Generous PTO and global recharge days

Savings and investment plans

Location-specific perks

Descrizione del lavoro

Moderna is seeking an Associate Director of Investigations & Operational Performance in Norwood, MA to enhance investigation rigor, CAPA actionability, and overall inspection readiness. You will guide systemic problem solving, risk assessment, and continuous improvement across Manufacturing Ops, QA, and Strategy.

The role emphasizes leading complex investigations, driving CAPA effectiveness, and building organizational capability through coaching and governance.

Competenze

• Experience leading investigations, CAPA, root cause analysis, or operational improvement programs in a GMP environment.
• Experience with GMP inspection readiness.
• Strong understanding of manufacturing operations, quality systems, and continuous improvement methodologies.
• Proven leadership, stakeholder influence, and change-management experience.

Mansioni

• Own and continuously improve investigations across the site to drive learning and systemic improvement.
• Lead cross-functional investigations and systemic problem‑solving across organizations.
• Lead CAPA effectiveness to address systemic issues and improve performance.
• Partner with Operations, Logistics, Quality, and Digital Operations to strengthen performance and reliability.
• Build organizational capability in investigation excellence and root-cause analysis through coaching and training.
• Own site governance processes including Investigation Reviews and CAPA Effectiveness Reviews.
• Use data analytics to identify opportunities for performance improvement and risk reduction.
• Lead the site's continuous Inspection Readiness program with QA.
• Translate regulatory trends into readiness priorities and improvement actions.
• Develop site-wide inspection capability via readiness assessments and simulations.
• Lead a high-performing team of advisors, investigators, and change agents.

Conoscenze

Investigation leadership

CAPA effectiveness

Root cause analysis

Regulatory inspection readiness

Cross-functional collaboration

Stakeholder influence

Change management

Formazione

Bachelor's degree in a technical discipline

Descrizione del lavoro

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.

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.

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.