Moderna Therapeutics Inc. Looking for Director, Global Quality Assurance for Quality Control at Cambridge, Massachusetts Full Time

The Role

Reporting to the Executive Director, Clinical and Development Quality, the Sr. Director/Director of Global Quality Assurance for Quality Control (QC), based in Norwood, MA, you will be responsible for ensuring the highest standards of quality and compliance across our global testing laboratories both internal and external for commercial and clinical operations. You will oversee all aspects of quality assurance related to quality control testing and transfer activities, implementing, and maintaining robust quality systems, and driving continuous improvement initiatives. Your leadership will be crucial in maintaining regulatory compliance, maintaining inspection readiness of the laboratories, and fostering a culture of quality throughout the organization.

This role requires domestic and international travel (minimum 20% but will often be higher based on business needs).

Here’s What You’ll Do:

• Quality oversight for testing and stability program strategy and requirements for internal and external QC testing for Analytical Chemistry, Bioassay, and Microbiology functions in support of raw material, in-process, drug substance, and finished product for overall day to day testing operations of mRNA products

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

• Quality oversight for QC laboratory investigations, change controls, deviations including resolution of Out of Specifications (OOS) and Out of Trends (OOT) observations, and CAPAs for relevant QC operations and ensure knowledge sharing across the QC laboratory network.

• Monitor key quality system metrics, process indicators, and overall health of the cGMP Quality Management System (QMS) to proactively identify and address quality systems or testing issues and ensure its continuing stability, effectiveness, and improvement.

• Review and approve analytical methods, specifications, and validation protocols to ensure their suitability for release testing and stability studies.

• Collaborate with supply chain and manufacturing teams to address quality related issues, investigations, and deviations when necessary.

• Provide QA support as a subject matter expert for internal and external testing sites and product related inspections (e.g., Pre-Licensing Inspection (PLI) and periodic cGMP inspections).

• Support CMC deliverables including content authoring and review of Quality owned sections for INDs/IMPDs, BLAs/MAAs and Health Authority information requests and communications and ensure robust analytical control strategy and holistic data package for supporting regulatory filings.

• Supports the development of people within the facility and has ultimate responsibility for laboratory full compliance with all statutory, regulatory and Moderna requirements

• Assures the appropriate management of all activities related to continuous improvement, Technology and Digital Strategy, business processes, Quality Culture, and people development

• Contributes to the growth and profitability of the Company, by ensuring safety, quality, compliance, productivity, and cost effectiveness

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

• Bachelor’s degree with 15-20 years of experience in progressive multi-functional leadership roles with a preference for that experience to have been in the biotechnology or vaccines companies.

• Excellent analytical, problem-solving, and decision-making skills.

• Quality Assurance, quality control operations, analytical development, and analytical transfer experience preferred.

• Comprehensive knowledge of global cGMP regulations, guidance, and industry standards.

• Superior customer service mindset with excellent interpersonal and communication skills

• Biased to reduce complexity and create simple and organized data systems

• Desire and interest to leverage new technology and innovative information management tools

• Demonstrated problem detection and problem resolution skills

• Demonstrated people leadership skills with a passion for talent development.

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!

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 (url removed).

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

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 proud to be an equal opportunity workplace and is an affirmative action employer.

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 an E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.

Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. We’re focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to 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 make a request to the Talent Acquisition Partner or contact the Accommodations team at (url removed). (EEO/AAP Employer)

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