Job description
The Role:Moderna is seeking a Manager to support Quality on The Floor (OTF) team as we ramp. This team provides oversight of manufacturing activities and Facilities at Moderna Inc. This position will be based in our cGMP Manufacturing site in Norwood, MA and will directly support the growing Personalized Medicine Program at the Norwood, MA site. The main responsibility for this position will be to provide additional support and guidance to the QA OTF by scheduling or providing training, provide quality oversight of manufacturing and Facilities, with a focus on deviations, change controls, CAPAs, and method qualifications/validations as needed. This position will support metrics establishment, shift change, Tier development, and other communications as required for QA OTF ramp up. This position will be both tactical and strategic as we work to onboard new employees and ramp the manufacturing process. Strong decision-making skills and independent thinking will be paramount for candidate success. The individual will work closely with leadership team, managers, specialists, and others from Manufacturing, Quality Control, Quality, and Facility teams.
Here’s What You’ll Do:
Establish/support key metrics for QA OTF and QA for QC.
Support and provide guidance on shift change, tier development, and other communications throughout the team.
Support scheduling and tracking training for new QA OTF employees as well as guidance on improvements to training.
Spearhead skills assessment of QA OTF and QA for QC team.
Provide additional support for quality on-the-floor managers and specialists including provide support of manufacturing, reviewing documentation, and providing real-time support of manufacturing issues change overs, as needed.
Support quality decisions that may impact operations, ensuring appropriate escalation.
Identify risks and communicate gaps for quality and GMP process/systems.
Reviews and approves facility alarms, facility work order requests, and return-to-service documentation.
Supports and provides guidance for deviations and change controls
Authors and reviews SOPs, policies to ensure compliance and adherence to regulations/cGMP operations.
Collaborate with Manufacturing to resolve equipment and process issues
Provide guidance and support for internal audits and external audits from customers and health authorities.
Practice safe work habits and adhere to Moderna’s safety procedures and guidelines.
Here’s What You’ll Bring to the Table:
BS with 8+ years of experience, or a Master’s level degree with at least 6 years’ experience in the pharmaceutical/biotech industry.
Highly organized with a focus on details.
Experience in metric development/tracking/automation 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
- 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!
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.
-
laviolettawines.com.au is the go-to platform for job seekers looking for the best job postings from around the web. With a focus on quality, the platform guarantees that all job postings are from reliable sources and are up-to-date. It also offers a variety of tools to help users find the perfect job for them, such as searching by location and filtering by industry. Furthermore, laviolettawines.com.au provides helpful resources like resume tips and career advice to give job seekers an edge in their search. With its commitment to quality and user-friendliness, laviolettawines.com.au is the ideal place to find your next job.