Associate Director, R&D Quality

ModernaTX

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profile Job Location:

Cambridge, MA - USA

profile Monthly Salary: $ 142500 - 256500
Posted on: 30+ days ago
Vacancies: 1 Vacancy

Job Summary

The Role:

We are seeking a highly motivated and experienced Associate Director to join Research & Development Quality with a focus on vendor quality. The role owns Quality Agreements (drafting through periodic review) manages vendor quality metrics and governance and plans/leads riskbased audits with durable CAPA followthrough. The successful candidate will strengthen inspection readiness harmonize processes and job aids and enable datadriven oversight of vendors in a fastmoving environment.

Heres What Youll Do:

  • Own the lifecycle of Quality Agreements (scope drafting/redlining execution periodic review and change control).

  • Establish and maintain a vendor quality metrics framework dashboards and governance cadence; trend and escalate risks.

  • Lead and/or oversee riskbased vendor audits (GCP/GLP/GCLP as applicable); plan conduct report and verify CAPA effectiveness.

  • Partner with stakeholders to prioritize and qualify/approve vendors.

  • Lead or contribute to crossfunctional teams with Procurement and Legal to align MSAs/SOWs with Quality Agreements.

  • Author or update SOPs work instructions and job aids to harmonize vendor quality processes across RDQ&C.

  • Utilize quality systems (e.g. Veeva QMS/QualityDocs eTMF issue/deviation management) to manage agreements audit records and performance.

  • Provide training and coaching to study and functional teams on vendor quality obligations and audit/inspection behaviors.

  • Collaborate cross-functionally to enhance vendor oversight practices and foster continuous improvement.

  • Ability to travel 1030% (domestic and international).

Heres What Youll Bring to the Table:

  • Bachelors degree in life sciences or related field required.

  • 8 years of experience in R&D Quality Quality Assurance or related discipline within the pharmaceutical/biotech industry

  • Proven track record drafting and negotiating Quality Agreements with Legal/Procurement and external partners.

  • Demonstrated experience planning/leading GxP audits and driving effective CAPAs to closure.

  • Strong working knowledge of ICH E6 (R2/R3) GCP/GLP/GCLP data integrity principles and 21 CFR Part 11/EU Annex 11.

  • Comfort with quality systems and metrics (e.g. Veeva reporting/visualization tools); concise executiveready communication.

  • Excellent stakeholder management and influence skills; ability to operate in a fastpaced highgrowth environment.

  • Preferred: vendor oversight across clinical and nonclinical domains (e.g. CROs central/specialty labs eClinical/data platforms).

Pay & Benefits

At Moderna we believe that when you feel your best you can do your best work. Thats why our US benefits and global well-being resources are designed to support youat 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 $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.

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 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

The Role:We are seeking a highly motivated and experienced Associate Director to join Research & Development Quality with a focus on vendor quality. The role owns Quality Agreements (drafting through periodic review) manages vendor quality metrics and governance and plans/leads riskbased audits with...
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Key Skills

  • Laboratory Experience
  • Vendor Management
  • Design Controls
  • C/C++
  • FDA Regulations
  • Intellectual Property Law
  • ISO 13485
  • Research Experience
  • SolidWorks
  • Research & Development
  • Internet Of Things
  • Product Development

About Company

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Learn how we’re changing the world of medicine. Discover career opportunities, our product pipeline, and browse media resources. Meet Moderna.

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