Director, Quality Control Operations

The Role:

Moderna is seeking a Director of Quality Control (QC) Operations based at our Moderna Technical Center (MTC) state of the art cGMP Manufacturing Facility in Norwood, MA to oversee the testing for Chemistry, Bioassay, Microbiology, and Stability functions in support of Modernas mRNA Personalized Cancer Vaccine. This critical leadership role will manage a QC organization focused exclusively on an exciting personalized clinical program and drive the implementation and maintenance of end-to-end sample management, testing, and COA generation leveraging digitally-integrated methods and laboratory systems in accordance with cGMP requirements. The QC Director will lead a talented team of laboratory professionals and oversee performance management, mentoring and career development. They will have the opportunity to collaborate closely with our network of QC laboratories internally and around the globe, Technical Development, Digital/IT, QA, Manufacturing, CMC Program Management, and Regulatory organizations to provide strategic direction and guidance on world class robust and efficient QC programs, systems, policies and standards, data analysis and trending in support of clinical and commercial manufacturing activities. This position will be expected to work in a highly collaborative, cross functional team environment, and provide expert knowledge to the development, implementation, and maintenance of systems and activities, support sites in regulatory and third party inspections, and provide technical support for specification and method development and troubleshooting and laboratory out of trend (OOT) and out of specification (OOS) investigations.

Heres What Youll Do:

• Responsible for strategic planning, capacity analysis, resource allocation and oversee day to day operations of the MTC QC Clinical cGMP Laboratories for a personalized medicine program

• Assists in development of appropriate standard operating procedures, laboratory data collection and documentation systems and training of personnel to ensure cGMP compliance.

• Ensure QC framework processes and policies/standards are established, implemented, audited, and continuously improved for the enterprise to ensure cGMP compliance with global regulations.

• Oversee QC data analytics, monitoring and trending for release and stability programs.

• Manages QC laboratory investigations, change controls, deviations, and CAPAs for relevant QC operations

• Works with Digital/IT to continually strengthen data integrity across the analytical chemistry and bioassay and laboratories

• Provide QC technical support for internal and external testing sites and product related inspections (e.g. Pre-Licensing Inspection (PLI) and periodic cGMP inspections).

• Support Annual Product Quality Review (APQR) activities and Regulatory filings.

• Owner of and drives optimization of laboratory processes and systems (e.g in-process and release testing programs, raw materials, EM, LIMS, Stability program, reference standard program, retain program, critical reagents program); drives compliance at both internal and external laboratories to meet and exceed all Moderna standards and global regulatory requirements.

• Development and implementation of QC performance metrics to monitor the health of systems, drive proactive identification of risk and compliance issues, and manage prioritization of transformational and continuous improvement activities to ensure delivery of scientifically sound and efficient QC methods.

• Provides technical QC support to manufacturing and quality during manufacturing and/or QC investigations.

Heres What Youll Bring to the Table:

• Bachelors degree with a minimum of 15-20 years of quality experience in the biotechnology or pharmaceutical industries with 5+ years experience leading global QMS; 10-15 years with a MS. Advanced degree preferred.

• Experience with personalized medicine, cell and gene therapies preferred

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.

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