Reporting to the Senior Director, Global Quality Systems and Standards is responsible to setting, coordinating, and overseeing the performance of the Global GxP Training and Personnel Qualification Quality System within the Global Quality Organization. Working in collaboration with Moderna University, Global and Local GxP teams and stakeholders, ensuring that the Training and Personnel Qualification function is maintained in a compliant and effective manner, considering:
- Global GxP regulations and industry standards
- Adult learning principles and effective modalities
- Experience in design of educational content and learning plan design
- Digitalization plans and opportunities
- Resources, strategy, and mid and long-term projections
The incumbent will leverage proven human performance improvement methodologies, leading team and cross-functional initiatives achieving sustainable and measurable quality and business results.
The candidate will be an integral partner to Moderna's innovative technology platform as we continue to integrate automation and digital technology into everything we do. Here's What You'll Do:
Here's What You'll Bring to the Table:
- Lead Global Quality Training Network projects, ensuring strong connection between the Global Quality team and stakeholders. Lead improvement efforts for prioritized processes and support other initiatives as required
- Act as a key GxP representative to Moderna University
- Interact with system/process/operations owners, to help define and document required content, role-based learning requirements
- Own required GxP learning framework from onboarding, through qualification and re-qualification.
- Serve as project manager and mentor, providing guidance to Global Quality Training Network and Relevant Expert Networks, Global Quality members and relevant teams.
- Demonstrates leadership and acts as a change agent, constructively challenging to generate open minded thinking
- Apply change management methods to ensure effective execution of the training and personnel qualification system, and to promote a quality culture and mindset of continuous improvement
- Build, maintain and leverage relationships across the matrix to identify opportunities for process improvement and facilitate the implementation and continuous monitoring of the training and personnel qualification system, staying up to date on developments in regulations, and best practices
- Interface with key stakeholders, sponsors, and other senior management to confirm system/project sponsorship/support, strategic alignment, report progress, recognize achievements, and drive decision for significant issues and risks.
- Performs other administrative/managerial duties as required.
Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:
- Bachelor's Degree in Chemistry, Biology or a related scientific discipline, or equivalent work experience
- MS or equivalent and 5 - 7 years of experience, or a Bachelor level degree or equivalent and 8 - 10 years' experience in the pharmaceutical/biotech industry
- Minimum of 3 years of experience in GxP training and education or equivalent
- 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!
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.