Associate Director, Quality Systems and Compliance External QA at Moderna Therapeutics in Norwood, Massachusetts

Job Description:

The Role:

Reporting to the Sr. Director of US External Quality Assurance , the Associate Director Quality Systems and Compliance will be responsible for leading implementation of quality system processes and operations to ensure Moderna exceeds the highest level of compliance while monitoring the health of the Quality Management System (QMS) for continuous improvement in support of the US external organization. The Associate Director will participate in internal, supplier quality and health authority audits, support document control, training and records management and assist in building a culture of quality at the site and oversee Moderna's QMS in support contract testing and manufacturing facilities and overall US operations for Moderna clinical and commercial products.

Here's What You'll Do:

• Support implementation and management of Moderna's overall Quality Management System (QMS) and quality manual, policies and procedures for the international organization and ensure continuous improvement while keeping it current with emerging and changing regulations, guidance documents and current industry best practices and expectations.




• Lead Compliance governance activities such as but not limited to Quality Management Review and regional and local Change Control Review Boards.




• Oversee the performance of Moderna's QMS monitoring the state of control through metrics and key performance indicators for Moderna's international organization and CMOs.




• Perform audits in support of the internal and supplier quality audit programs and support and/or host third party/regulatory inspection programs.




• Implement practices in document and records control, management, and retention to ensure robust training, compliance, data integrity, and continuous improvement for the rapidly expanding GXP international environment.




• Manage the performance and effectiveness of the quality system programs such as risk management, change management, discrepancy and CAPA management, training, documentation and records management, and data integrity.




• Work collaboratively with the digital team on the GXP integrated digital landscape to support all e-systems, the utilization of data to accelerate and inform process and system performance and value stream roadmaps for long range planning.




• Provide cross functional quality leadership and act as a GXP compliance subject matter expert on technical matters involving product examination, testing and disposition, quality investigations, validation, data integrity, and in business matters involving facility and laboratory operations.




• This role requires limited travel.

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

• BS in a scientific or engineering discipline with at least 12 years' experience in pharmaceutical / biotech industry within Quality Assurance or Quality (Assurance) exposure




• Working knowledge of relevant EU and global regulations and ICH, ISPE, ASTM standards/guidelines and experience in leading successful regulatory international inspections.




• Extensive experience developing and managing a Quality Management System in a GMP setting and preferably experience in GCP, GLP, GVP, GDP.




• Experience in computerized systems, automation, operations and manufacturing and testing within biotechnology industry.




• Excellent interpersonal skills using a team-oriented approach to project management and problem solving for complex issue resolution in a scientifically sound and understandable way.




• Outstanding communication skills (verbal and written) to all employee levels, executive leadership and external partners, suppliers, third parties, and industry organizations.




• Ability to conceptualize, analyze, plan and manage multiple projects in a fast-paced environment.




• Ability to be agile and effectively collaborate in a dynamic, cross-functional matrix environment.




• Ability to navigate through ambiguity and rapid growth and adapt to change.

Here's What We'll Bring to the Table:

• On-site subsidized cafeteria or catered lunches


• Company-provided iPhone


• Free parking, monthly subway pass or a subsidized commuter rail pass


• Free annual corporate membership to Bluebikes


• Highly competitive healthcare coverage including: medical offered through BCBS (HMO/PPO), dental, and vision offered through VSP


• Flexible Spending Accounts for medical expenses and dependent care expenses


• 16 weeks of 100% paid parental leave for all new parents


• 16 weeks 100% paid family caregiver leave


• 20 weeks 100% paid medical leave


• Eligible for "Moderna Month" (one month paid sabbatical after five years of service and eligible for additional one month paid sabbatical every 3 years thereafter)


• Adoption assistance and discounts to local childcare centers, as well as access to care.com


• 401k (traditional and Roth offered) with 50% match on first 6% deferred. Match is vested immediately


• A suite of Moderna paid insurance coverage, including: life insurance, short-term and long-term disability


• Voluntary legal assistance plan


• 15 days' vacation and 7 sick days per year, in addition to a discretionary winter shut down and 11 company paid holidays (includes 2 floating holidays)

About Moderna:

In 10 years since its inception, Moderna has transformed from a science research-stage company advancing programs in the promising-but-still-unproven field of messenger RNA (mRNA), to an enterprise with its first medicine having treated millions of people, a diverse clinical portfolio of vaccines and therapeutics across six modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for both clinical and commercial production at scale and at unprecedented speed. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. Most recently, Moderna's capabilities have come together to allow the authorized use of one of the earliest and most-effective vaccines against the COVID-19 pandemic.

Moderna's mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and auto-immune diseases. Today, 24 development programs are underway across these therapeutic areas, with 13 programs having entered the clinic. Moderna has been named a top biopharmaceutical employer by Science for the past six years. To learn more, visit www.modernatx.com.

Moderna is a smoke-free, alcohol-free and drug-free work environment.

Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

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