Reporting to the Director, Quality Systems and Compliance this person will be responsible for cGMP compliance of process, facility, utilities, equipment, method and computer system validation and will be accountable for their execution across a Moderna execution team (internal site). The role is responsible for overseeing the review and approval of all validation records and documentation (i.e. equipment qualification, cleaning validation, and computer system validation) are compliant with in-house specifications/standards/procedures and Good Manufacturing Practices.
This role will support the growing Personalized Cancer Therapy Program at the Norwood, MA site.
Here's What You'll Do:
Here's What You'll Bring to the Table:
- Responsible for maintaining Validation procedures to ensure compliance with site polices, regulatory guidelines, and industry best practices.
- Manage teams responsible for providing Quality review and approval of commissioning, qualification, and validation activities.
- Provide leadership, guidance, and coaching for all direct reports to maintain an engaged and productive workforce
- Responsible for the review/approval of design and commissioning documentation, validation protocols (including associated discrepancies), reports and support records to certify compliance with specifications and procedures; ensures timely resolution of documentation, compliance, and quality system issues.
- Reviews and assists in investigating deviations related to manufacturing process equipment, utilities, automation, computer systems, validation, methods and laboratory instruments.
- Responsible for performing change control assessments and reviewing/approving change control implementation plans for process, equipment, utilities, method and computer system validation.
- Participates in continuous quality system improvements and supports implementing improvements in the GMP Validation and Change Control Programs.
Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:
- B.S. degree (engineering or scientific discipline) with at least 6 years' experience in QA Validation in the pharmaceutical industry or related fields; 5-8 years' with MS, 0-2 with phD
- 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 winter shut down
• 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 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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