Moderna is seeking a Manager, Quality Control Technical Support based at their Norwood, MA site. This position reports to the Director of Quality Control. This individual will be a crucial member of the Quality Control team, contributing to the development and performance of Quality Control (QC) methods, systems, policies, processes, procedures and controls as they relate to QC testing of raw materials, intermediates, drug substances, and drug products at both the Norwood site and supporting testing performed at CMO and CTLs.
Heres What Youll Do:
Review executed QC test records for product release, including the investigation and resolution of deviations, OOS and OOT observations.
Supports internal and external teams to Investigate and resolve issues related to assay failures, system deficiencies, deviations, and equipment / assay troubleshooting.
Manage CAPAs and Change Control efforts within the department
Support raw material onboarding assessments
Responsible for approval of document reviews, periodic reviews and documentation revisions as needed.
Authors Equipment and Method SOPs, Instrument Qualification documentation, Computer system validation documents and method lifecycle documents.
Lead continuous improvements of quality systems (procedures and systems) to improve organization effectiveness, quality assurance compliance, and regulatory and other requirements
Leads team to identify and mitigate risks to meeting QC milestones and goals.
Assist in Quality Metric review processes, assess data for adverse trends, develop solutions and oversee implementation.
Coordinate training, professional development and growth of the QC staff.
Prepare, provide and manage schedules for testing.
Participate in and partner with the Digital team to expand and optimize the use of the LIMS (LabVantage) system.
Provide guidance and support to the QC team for compliance issues. Support preparation, management and response to compliance audits.
Establish and maintain a safe laboratory working environment
Heres What Youll Bring to the Table:
Bachelors degree in relevant scientific discipline with minimum 8 years in a GMP QC laboratory setting, preferable in Microbiology and/or Bioassay testing.
Demonstrated proficiency with Quality System Records, Deviations, Change Controls and CAPAs
Previous supervisory experience is required, including testing scheduling and lab project management.
Strong knowledge of general laboratory operations, method acquisition, qualification.
Strong technical writing skills
Demonstrated knowledge of method transfers and qualification/validation
Proficiency with Microsoft Office Programs
Familiarity with electronic databases (e.g. LIMS, SAP, LMS) and QC operations
Strong written and oral communication skills as well as organizational skills
Knowledge of industry standards and guidelines, experience supporting compliance audits.
Demonstrated ability to work effectively under established guidelines and instructions
Ability to collaborate effectively in a dynamic, cross-functional matrix environment.
Knowledge of relevant and current FDA, EU, USP, ICH guidelines and regulations.
Ability to efficiently prioritize and complete multiple projects and tasks in a fast-paced environment.
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 persons 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.