- Perform all activities including audit preparation, conduct, presentation, and timely reporting of audit findings, and evaluation of CAPAs.
- Present observations to auditees and prepare a written audit report.
- Participate in post-audit meetings to discuss unresolved issues with Senior Management.
- Identify and report systematic issues beyond the individual audit findings as well as opportunities for process improvements.
- Support regulatory agency inspections and vendor audits as needed.
- Participate in compliance projects and initiatives.
- Perform other tasks as assigned by line manager.
- Travel up to 30% may be required.
- Additional duties as may be assigned from time to time.
- A miniumum of a BS / BA with 5 to 8 years of experience in Biotech, Pharmaceutial or Clinical Research organization in the GCP environment is required.
- Understanding and familiarity with FDA & European regulatory requirements, guidelines, and recommendations GCP (understanding of regulatory guidelines for other countries a plus).
- Practical knowledge of GCP related audits activities and business standards.
- Expertise with business office applications, word processing and spreadsheets.
- Demonstrated knowledge and/or prior experience in Quality Assurance.
- Ability to work both independently and in a team environment.
- Excellent analytical, problem solving and decision-making skills in a complex, fast-paced, and changing environment.
- Excellent communication and presentation skills, both verbal and written.
- Ability to influence and negotiate effective solutions, excellent interpersonal skills.
- Ability to manage multiple projects in a fast-paced environment.
- A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.
- 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
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senior specialist, clinical quality - Cambridge, MA, United States - Moderna, Inc.
Description
The RoleIn this role, you will function as an internal auditor and will provide clinical quality support related to GCP global regulation and guidelines to Clinical and Research and Development teams. Additionally, the Senior Specialist/Specialist applies established knowledge and experience with GCP regulations, guidelines and local legislation to the auditing process to identify compliance issues associated the with conduct of clinical trials. The appointee will also be responsible to partner with study teams to create a quality culture within Moderna to help reach a sustained state of inspection readiness.
Here's What You'll Do
Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world.
By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.
We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.
As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute and make a meaningful impact.
If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit to learn more about our current opportunities.
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. We're 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 contact the Accommodations team at (EEO/AAP Employer)
