Controlled Document Strategy & Execution Lead

The Role:

This is a strategic leadership role responsible for driving the design, management, and implementation of processes and controlled documents to ensure the organization operates in a proactive state of inspection readiness. The successful candidate will partner closely with the Head of Process Management, Training and Execution, as well as Clinical Compliance and Inspection Readiness, to deliver scalable solutions that strengthen compliance, streamline operations, and enable execution excellence.

The ideal candidate brings deep expertise in controlled document strategy and process management, combined with proven leadership skills to drive organizational transformation in a fast-paced and highly regulated environment. This leader will shape and execute strategy, oversee implementation, and foster a culture of quality, innovation, and continuous improvement across the organization.

Here’s What You’ll Do

Strategic Leadership & Implementation

• Lead the development, optimization, and enterprise-wide implementation of Clinical Development processes, controlled documents, and tools to deliver a prioritized pipeline of procedural improvements.

• Define and execute the controlled document development and rollout workflow, ensuring scalability and alignment with enterprise needs.

• Establish and manage a hybrid strategy framework with vendor partners for SOP list management, ownership, and trial-level implementation.

Process & Compliance Excellence

• Drive end-to-end process improvement for controlled documents in partnership with mPROVE, ensuring seamless intake through execution.

• Conduct SOP and process gap assessments across internal and external stakeholders; lead change management and implementation of solutions.

• Align with Compliance and Quality (QIs, QEs, CAPAs, Inspection Findings) to proactively address risks and strengthen inspection readiness.

Technology & Infrastructure

• Develop and oversee digital solutions (e.g., Smartsheet, validated systems such as Please Review) to track, manage, and mitigate risks associated with controlled document development, training integration, and document versioning.

• Implement standardized controlled document templates and digital tools that enable clear ownership (Moderna/CRO/shared) and ensure audit readiness.

Training Strategy & Execution

• Integrate SOP strategy with training management systems to ensure automated assignment, tracking, and compliance monitoring.

• Partner with training curriculum owners to validate structures, strengthen oversight, and ensure consistency across the enterprise.

Metrics, Reporting & Continuous Improvement

• Define and track KPIs, deliverables, milestones, and timelines for controlled document development and roll-out.

• Analyze systems and processes, providing recommendations for optimization or new solutions to enhance compliance and efficiency.

• Embed a culture of continuous improvement, identifying opportunities to reduce cost and cycle time while maintaining quality and regulatory rigor.

• Provide regular updates through governance forums, leadership reviews, and cross-functional town halls.

Here’s What You’ll Bring to the Table

• BA/BS required; advanced degree preferred (or equivalent experience)

• Minimum of 10 years of experience in the pharmaceutical or biotechnology industry, or in a similiar regulated environment, with demonstrated leadership in training program development, controlled document management and process improvement

• Proven track record of building and leading high-performing teams; experience developing talent into future leaders

• Direct experience with controlled document development within Clinical Development

• Strong knowledge of document management systems and digital workflow tools

• Deep understanding of CROs, third-party vendors, and collaborative operating models

• Solid knowledge of FDA and ICH GCP guidelines and their application to clinical trials

• Exceptional communication and influencing skills; able to engage internal and external stakeholders at all levels

• Proven ability to drive multiple high-impact initiatives in a fast-paced, results-oriented environment

Under Washington State law, Moderna is required to provide a reasonable estimate of the salary range for the jobs covered by this description.  Base compensation for these positions in Washington State range from $142,500 to $256,500. Actual salary determinations will take into account factors such as work location, prior education and experience, job-related knowledge, and demonstrated skills.  Compensation decisions are made on the facts and circumstances of each case.

In addition to base compensation Moderna employees are eligible for a comprehensive incentive compensation package including an annual cash bonus, new hire equity and an annual refresh, 401(k) match, competitive and inclusive medical, dental, and vision coverage options, flexible spending accounts for medical and dependent care, Life, LTD, and STD insurance, paid family leave offerings, including at least 16 weeks of 100% paid parental leave, adoption, surrogacy, and family-planning benefits, generous paid time off, including:

•    Vacation, sick time, and observed Company-wide holidays

•    Paid volunteer time to participate within your community

•    Discretionary winter holiday shut down

•    Paid 4-week sabbatical after 5 years, and every 3 years after

Pay & Benefits

At Moderna, we believe that when you feel your best, you can do your best work.  That’s why our US benefits and global well-being resources are designed to support you—at work, at home, and everywhere in between.

• Best-in-class healthcare coverage, 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 investment opportunities 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. 

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. 

Our Working Model 

As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. 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. 

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, 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

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 [email protected]. 

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.

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