Director, Clinical Quality - Drug Product

Moderna; Norwood (MA); On-site; USD 120,000 - 160,000; Full time

Job summary

A leading company in biotechnology is seeking a Director of Clinical Quality to oversee Drug Product manufacturing in Norwood, Massachusetts. The successful candidate will provide quality leadership and ensure compliance with regulatory requirements while also developing the team's capabilities. This role involves significant interaction with regulatory bodies and requires strong expertise in quality systems management. The position allows some telecommuting and requires minimal travel.

Benefits

Best-in-class healthcare coverage

Holistic well-being resources

Generous paid time off

Family planning benefits

Qualifications

• 8+ years of experience in quality assurance roles in biotech.
• Experience with regulatory compliance (FDA, EMA, TGA).
• Proven ability to lead quality assurance plans.

Responsibilities

• Provide quality leadership for cGMP Drug Product manufacturing.
• Oversee QA operations including batch record review and deviations.
• Engage with regulatory authorities to ensure compliance.

Skills

Quality leadership

Compliance management

Risk management

Root cause analysis

Operational Excellence

Education

Master’s degree in Biology or related field

Tools

Veeva Systems

Audit Utopia

Kneat Solutions

Maximo

Job description

The Role:

ModernaTX, Inc. seeks a Director, Clinical Quality - Drug Product for its Norwood, Massachusetts location.

Here’s What You’ll Do:

• Provide Quality leadership to the internal manufacturing of current Good Manufacturing Practices (cGMP) Drug Product for use in clinical trials.

• Maintain responsibility for a Quality Assurance (QA) organization overseeing formulation, filling, visual inspection, packaging, and labeling in addition to product disposition.

• Serve as a member of site governance and work with cross-functional leadership to build compliant and phase-appropriate processes.

• Lead the QA Operations team for Clinical Good Manufacturing Practices (GMP) Drug Product manufacturing.

• Lead QA on-floor support, batch record review, deviation management, change management, specifications, and product disposition as well as ownership of the Sterility Assurance program.

• Build and develop organizational capabilities to robustly support sterile drug product manufacturing, visual inspectional, and packaging.

• Provide leadership, guidance, and coaching for the multi-level organization to maintain an engaged and productive workforce.

• Ensure the Quality System, specifications, processes and objectives for the development, manufacture, release, and distribution of cGMP clinical drug product are aligned with global regulatory requirements and implemented, maintained, and understood.

• Engage in site governance as an active and influential leader to ensure product quality and compliance, as well as delivering on the site objectives.

• Develop short and long-term plans, in collaboration with business partners, to achieve both quality and business objectives.

• Develop and monitor key quality performance indicators to proactively identify and address quality system or product issues and ensure its continuing stability, effectiveness, and improvement.

• Champion Operational Excellence in all aspects of total quality management through a well-trained workforce, streamlined business processes, and appropriate structured quality operations.

• Interface directly with Food and Drug Administration (FDA), European Medicines Agency (EMA), Therapeutic Goods Administration (TGA), Health Canada, and other regulatory authorities, external partner audits, and Qualified Persons (QPs) to ensure the company is appropriately represented in matters related to compliance and quality.

• Develop resource strategies, allocate budget, staff, tools, and specialized support necessary for efficient operations.

• May telecommute 2 days per month.

• Position requires up to 5% domestic and international travel, fully reimbursed.

Here’s What You’ll Bring to the Table:

Minimum requirements:

• Requires a Master’s degree, or foreign equivalent, in Biology, Molecular Biology or related field and 8 years of experience in the position offered or as Director of Quality Systems, Director of Quality Assurance, Director of Aseptic Processing, Sterility Assurance Manager/Associate, or related position within biotechnology manufacturing.

• 8 years of experience must include:

  • Ensuring compliance with FDA, European Medicines Agency, Therapeutic Goods Administration, and Health Canada regulations;

  • Internal Audits, quality metrics and reporting, risk management, deviations, and Corrective and Preventative Actions (CAPA) management;

  • Quality Management Systems (including Veeva Systems, Audit Utopia, Kneat Solutions and Maximo);

  • Conducting root cause analysis, implementing CAPAs, and issue management;

  • Aseptic processing and sterility assurance; and

  • Building and maintaining quality assurance plans with action execution and health checks for biotechnology manufacturing sites.

• May telecommute 2 days per month.

• Position requires up to 5% domestic and international travel, fully reimbursed.

Apply at https://modernatx.wd1.myworkdayjobs.com/en-US/M_tx (Job ID: R17905) or email resume and cover letter to [e-mail] with subject line: R17905.

#DNI

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 a suite of voluntary benefit programs to support your unique needs
• A holistic approach to well-being, with access to fitness, mindfulness, and mental health support
• Lifestyle Spending Accounts to personalize your well-being journey
• Family planning and adoption benefits
• Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown
• Savings and investment opportunities
• Location-specific perks and extras

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 [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.

#LI-NB1

-