In this role, the Quality Control Compliance Training Manager will be responsible for oversight of the QC training programs for the Moderna Norwood labs. The successful candidate will be required to work with a broad team including various QA departments, all QC internal departments, Analytical Sciences & Technology and more. Accordingly, this position will be expected to work in a highly collaborative, cross-functional manner and provide training oversight and guidance to the broader QC department.
Heres What Youll Do
Provide management and oversight of the QC training programs, including maintaining and revising training curricula, creating training content and materials, implementing training plans and ensuring appropriate assignments are made based on roles.
Manage QC on-the-job training content and assignment of appropriate qualified trainers; create new on-the-job training materials as identified and required.
Own and implement proactive, corrective or preventative actions related to QC training.
Own, investigate and/or participate in deviations related to training; assist with deviations by providing QC training records or other training materials as required.
Identify areas of training gaps and needs, and lead all QC training project initiatives, ensuring on time completion.
Track and report on QC training metrics, identifying areas for improvements and propose and implement action plans.
Oversee and provide performance management of direct reports as assigned.
Revise QC SOPs, forms, work instructions and other documentation as required to ensure clarity of procedures, appropriate level of instructions and compliance to regulatory requirements.
Represent QC Training in cross-functional meetings and provide input and collaboration as required.
Perform various document reviews as the QC Training stakeholder, as assigned.
Accept, complete, and report on special assignments within the agreed upon timeframe as assigned.
Perform all job functions with adherence to all relevant procedures, GxP, cGMP and associated regulatory requirements.
Heres What Youll Need (Minimum Qualifications)
5-8+ years of QC and/or QA experience in a pharmaceutical cGMP setting.
B.S. degree in relevant scientific discipline.
Excellent technical writing skills and experience authoring deviations, investigations, and procedures in a cGMP setting.
Knowledge of relevant and current FDA, EU, ICH guidelines and regulations.
Excellent ability to communicate in a scientifically sound and understandable manner.
Demonstrated ability to prioritize, manage and complete multiple projects and tasks in a fast-paced environment effectively and independently.
Ability to collaborate effectively in a dynamic, cross-functional matrix environment.
Ability to navigate through ambiguity and rapid growth and adapt to change.
Heres What Youll Bring to the Table (Preferred Qualifications)
MS in a relevant scientific discipline with 3-5+ years QC and/or QA experience in a pharmaceutical cGMP setting.
Previous experience in a laboratory compliance function within QC or QA.
A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.
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 year-end shutdown
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!
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. Were 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 firstname.lastname@example.org. (EEO/AAP Employer)