Associate Director, Clinical GMP Quality Systems and Compliance

The Role:
This role is an exciting opportunity to be a part of the Quality Assurance organization within the Clinical site at Moderna cGMP clinical manufacturing facilities in Norwood and Burlington, MA. As the company grows, the Quality Assurance Department is also growing and is looking for talented individuals with a strong Quality Culture and ability to adapt to a fast-paced environment. This role will focus on the audits (internal and external) and partner/collaboration management across the clinical portfolio as well as supporting other compliance activities enhance compliance at the Norwood and Burlington Clinical sites.

We work collaboratively as a team, we boldly strive for excellence, we are constantly curious and committed to ongoing learning and improvement, and we are relentless in our pursuit of having the highest level of Quality products.

Heres What Youll Do:

• Partner cross functionally to maintain a company culture that embraces compliance and recognizes that compliance is a collective responsibility of all company employees

• Lead and grow a team to support audits and partner management needs for a growing clinical GMP site.

• Provide leadership, guidance and coaching for all direct reports to maintain an engaged and productive workforce

• Continue to improve Modernas overall Quality Management System (QMS) and quality manual, policies and procedures while keeping them current with emerging and changing regulations, guidance documents and current industry best practices and expectations.

• Manage Internal Audit program through facilitation and participation

• Participate in supporting 3rd party audits including partner audits and Health Authority Inspections

• Support partner and collaboration programs with respect to authoring quality agreements, attending partner CMC meetings as the Quality representative and managing quality notifications, as needed.

• Monitor audit outcomes and audit findings to ensure timely CAPA follow-up, escalating as required

• Drive site to inspection readiness and continuous improvement

• Support, as needed, 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.

• Provide compliance guidance and training through various methods including formal and informal presentations and trainings

• Support stake holders in developing and implementing corrective and preventative actions as needed, communicating any critical compliance risks to senior management

• Support the establishment and reporting of quality metrics for GMP related functional areas

• Identify opportunities for quality system improvements

• Work collaboratively with the digital team on the GXP integrated digital landscape to support eDOC, eQMS, and LMS systems.

Heres What Youll Bring to the Table:

• Requires a bachelors or Masters degree (engineering or scientific discipline)

• Quality assurance experience in pharmaceutical industry providing Quality Assurance oversight 8-10 with BS degree, 7- 8 years of experience with MS degree or 5-7 years experience with PhD

• Ability to translate complex issues into a meaningful set of recommendations

• Demonstrated knowledge of cGMPs in a manufacturing environment

• Strong independent judgement and decision-making abilities

• Demonstrated problem detection and problem resolution skills

• Demonstrated leadership skills

• Ability to take initiative and work independently with minimal oversight

• Must possess demonstrated organizational skills

• Must possess excellent verbal and written

Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:

• Highly competitive and inclusive medical, dental and vision coverage options
• Flexible Spending Accounts for medical expenses and dependent care expenses
• Lifestyle Spending Account funds to help you engage in personal enrichment and self-care activities
• Family care benefits, including subsidized back-up care options and on-demand tutoring
• Free premium access to fitness, nutrition, and mindfulness classes
• Exclusive preferred pricing on Peloton fitness equipment
• Adoption and family-planning benefits
• Dedicated care coordination support for our LGBTQ+ community
• Generous paid time off, including:
  Vacation, sick time and holidays
  Volunteer time to participate within your community
  Discretionary year-end shutdown
  Paid sabbatical after 5 years; every 3 years thereafter
• Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents
• 401k match and Financial Planning tools
• Moderna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit options
• Complimentary concierge service including home services research, travel booking, and entertainment requests
• Free parking or subsidized commuter passes
• Location-specific perks and extras!

Candidates should be aware that Moderna currently maintains a policy requiring all US-based employees to be fully vaccinated against COVID-19 and receive a booster shot once eligible. Newly hired employees must be vaccinated and boosted prior to their employment start date. Moderna is an equal opportunity employer and will provide a reasonable accommodation to those unable to be vaccinated or receive a booster where it is not an undue hardship to the company to do so as provided under federal, state, and local law.

About Moderna

In over 10 years since its inception, Moderna has transformed from a research-stage company advancing programs in the field of messenger RNA (mRNA), to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across seven modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for rapid clinical and commercial production at scale. 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 and approval 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 autoimmune diseases. Moderna has been named a top biopharmaceutical employer by Science for the past seven 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 persons 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.

-