Job description
The Role:Reporting to the Vice President, PCV Quality Assurance, the Director, Quality Assurance Global PCV Distribution will be responsible for providing Quality Assurance (QA) oversight of Moderna’s Personalized Cancer Vaccine (PCV) distribution release and cold chain operations globally. The individual will primarily work with: supply chain logistics, clinical drug supply operations, manufacturing operations, digital, internal quality assurance and third-party logistics service providers to support the distribution and delivery of Moderna’s PCV drug product. This individual will ensure release controls including regional release and QP certification in Europe and UK, oversight of third-party distributors, cold chain and temperature excursion monitoring are designed to support compliant and efficient delivery of Moderna’s PCV drug product into the clinical supply chain globally. Similarly, this individual will provide strategic guidance on necessary quality elements needed to support a global commercial supply chain for PCV. Experience in drug product secondary labeling, barcoding, and distribution systems in a clinical and commercial environment is a plus. The successful candidate must have experience in a biotech or pharmaceutical GXP environment.
Here’s What You’ll Do:
Oversee quality release controls for PCV drug product distribution globally
Provide quality management of third-party distribution and logistics vendors
Manage the temperature excursion process and support data-based product impact assessments
Develop and update procedures to support PCV distribution and cold chain operations
Maintain and leverage distribution release metrics as well as vendor-based deviations to improve processes
Provide project management oversight and support for QP releases and other country
Implement quality assurance solutions to reinforce Moderna’s PCV cold chain
Drive improvements to help avoid cold chain deviations and improve deviation processing
Record and track metrics for key quality performance indicators for cross-functional visibility
Manage Clinical PCV distribution release timelines and Provide updates to internal and external customers on a regular basis
Provide strategic guidance and help implementation of a compliant and efficient commercial supply chain for PCV
Here’s What You’ll Bring to the Table:
Bachelor degree, relevant industry experience of 15-20 years; 10-15 with MS.
Working knowledge of relevant FDA, EU regulations and ICH standards/guidelines and experience in supporting successful regulatory inspections.
Knowledge in distribution controls, risk management, and quality system requirements.
Working knowledge of global distribution and release for biologic products including QP requirements.
Experience in management or application of quality systems and e-systems in a biopharma organization.
Experience in computerized systems, automation, labeling and ERP systems in the biotechnology industry is a plus.
Ability to interact effectively with all levels of personnel within the organization.
Proven ability to lead and manage projects/teams of significant scope and complexity in a matrix environment meeting timelines and quality requirements.
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).
Ability to navigate through ambiguity and rapid growth and adapt to change.
Ability to be agile and effectively collaborate in a dynamic, cross-functional matrix environment.
A ‘digital first’ and curious mindset that allows you to constantly learn and challenge the status quo.
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
- D iscretionary year-end shutdown
- Paid sabbatical after 5 years; every 3 years thereafter
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 www.modernatx.com.
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 leavesandaccommodations@modernatx.com. (EEO/AAP Employer) #LI-AG1
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