Moderna is seeking a Supervisor, Clinical Quality Operations to lead a team of QA Associates/Specialist responsible for quality oversight of Clinical Drug Product operations based at Moderna's Norwood location. This position is part of Moderna's Quality Assurance team responsible for ensuring quality oversight of our mRNA platform in Clinical Drug Product manufacturing. The main responsibility is to provide real time quality leadership and, on the floor, operational support for the clinical manufacturing team. The successful candidate will have experience in quality oversight or manufacturing experience in early stage clinical and commercial products. Strong decision-making skills and independent thinking will be paramount for candidate success. Candidate will interact fluidly with site management in Manufacturing, and cross-functionally within the Quality organization.
This is a 10-hour shift, Sunday - Wednesday (with a 7-8am EST start time)
Here's What You'll Do:
Manage Moderna's Clinical Quality team responsible for providing on-the-floor support of manufacturing, reviewing documentation, and providing real-time support of manufacturing issues.
Make quality decisions that may impact operations, ensuring appropriate escalation.
Coordinate training, professional development and growth of the Clinical Quality Assurance team.
Monitor process operations to ensure compliance with procedures and specifications.
Demonstrate knowledge of standard manufacturing compliance, quality disposition, quality system review.
Identify risks and communicate gaps for quality and GMP process/systems
Enforce adherence to current good manufacturing practices, standard operating procedures, and manufacturing documentation.
Partners with manufacturing and support management teams to focus on site initiatives.
Oversee and perform review of executed electronic and paper batch record documentation.
Practice safe work habits and adhere to Moderna's safety procedures and guidelines.
Utilize knowledge to improve operational efficiency.
Collaborate and lead effectively in a dynamic, cross-functional matrix environment.
Here's What You'll Bring to the Table:
Minimum of 6 years of experience in a GMP manufacturing environment, preferably within Quality, with a Bachelor's Degree in Life Science; and at least 1-year leading teams.
Working knowledge of relevant FDA, EU, ICH guidelines and regulations.
Experience working with aseptic fill and finish of vials preferred.
Auditing experience is a plus.
Excellent judgment and ability to communicate complex issues in an understandable way.
Outstanding communication skills (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 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.
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. #LI-PL1 -