Moderna is seeking a Manager of Quality Assurance Technical Inquiries for a position based at their Norwood, MA facility. The individual in this role will be responsible for developing and managing a program for inquiries received at Moderna. This individual will work with customers, Commercial Operations, Technical Development, Regulatory Affairs and MS&T to support general inquiries that are processed through the quality compliance group. This individual will support quality systems and governance, initiate investigations, follow up with internal and external stakeholders and drive continuous GMP improvement in the general inquiry management process. The successful candidate must have experience in a medical device, biotech or pharmaceutical GXP environment.
Reporting to the Senior Manager of global product quality complaints, this person will be responsible for developing and will be accountable for managing general inquiries that are outside the scope of standard complaint handling activities.
Heres What Youll Do:
Develop and manage a program to receive and respond to general inquiries that are not considered customer complaints.
Build and manage a team that will review, assess, and summarize issues, to understand requests and triage those requests to various stakeholders within the organization.
Serve as the inquiry group manager and engage in escalation activities commensurate with the issues; product risk assessments (e.g., Health Hazard Evaluations), quality holds and market action.
Provide guidance as requested and serve as a CAPA team leader for issues pertaining to general inquiries.
Follow-up with customers to gather information required for robust inquiry summaries and responses.
Develop responses to regulatory agencies, health authorities, market authorization holders and any other customers requiring formal responses to inquiries.
Maintain professional communications with internal and external customers to gain insight into each event.
Serve as liaison between various groups within Moderna to ensure voice of customer is being received by the appropriate stakeholders.
Work with stakeholders to ensure customer needs and response requirements are being addressed.
Apply sound, systematic, problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
Proactively analyze trends so appropriate actions may be implemented to resolve quality issues.
Lead and partner with cross-site and cross-functional associates in the pursuit of continuous improvement.
Assess investigations for adequacy and completeness and provide guidance and subject matter expertise to manufacturing regarding investigation results
Lead and complete projects as assigned.
Support internal and external audit activities as necessary.
Complete mandatory training by established due dates and always maintain training compliance.
Maintain and follow departmental processes and systems to ensure regulatory compliance.
Heres What Youll Bring to the Table:
Bachelors degree in a life science
Minimum 5-8 years experience within the biotechnology, medical device, or pharmaceutical industry.
Ability to write technical investigation summaries for multiple audiences
Excellent communication skills, both written and verbal.
Problem solving skills
Highly organized with strong attention to detail
Proficient is MS Word, Excel, Visio, and PowerPoint
Ability to prioritize workload and effective time management
Available to travel 20%
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 email@example.com. (EEO/AAP Employer)