Sr. Manager, Clinical Laboratory
3 weeks ago
Moderna is seeking a highly motivated and experienced Senior Manager of Laboratory Compliance to join our Clinical Biomarker Laboratory team. In this role, you will ensure our laboratories comply with GLP/GCLP guidelines and other applicable regulatory requirements, supporting the development, implementation, and maintenance of processes and procedures that uphold the integrity and quality of laboratory data. Effective communication is key to success, requiring excellent verbal and written skills to engage with diverse stakeholders.
The role will be responsible for driving compliance efforts to meet regulatory checkpoints across multiple laboratory and functional areas including governance document management, SOP writing, training program development, and data integrity. The candidate will support the laboratory teams emphasizing end-to-end laboratory operations. The Senior Manager for Laboratory Compliance will develop strong and efficient business relationship with cross-functional teams including the Clinical Biomarkers Laboratory team, partner laboratories within the Moderna CASL team, Research and Development Quality, Digital Solutions, and Facility Management.
The position reports to the Associate Director, Laboratory Compliance, Clinical Biomarker Laboratory at the Moderna Norwood, Massachusetts campus. On-site attendance is mandatory, as this is not a remote position.
Here's What You'll Do
- Lead the oversight and collaboration with interdisciplinary teams to ensure prompt documentation and effective management of non-conformances including root cause analysis and the resolution of Quality Events (QE).
- Guarantee that Corrective and Preventive Actions (CAPAs) are meticulously documented and implemented promptly by the scientific staff ensuring adherence to quality standards.
- Spearhead the internal audit program conducting comprehensive reviews of laboratory procedures and practices to identify areas for enhancement.
- Drive continuous improvement initiatives within the laboratory team fostering a culture of excellence and compliance.
- Actively participate in and provide robust support during external laboratory audits and regulatory inspections ensuring compliance with all relevant standards.
- Oversee the local development and implementation of strategies to centralize document storage encompassing both electronic and physical records management.
- Ensure the integrity and accessibility of staff training records keeping them current and in compliance with regulatory requirements.
- Assist in the creation and revision of SOPs providing critical review and constructive feedback on procedures developed by the team.
- Lead the scientific team in maintaining laboratory and study documentation in strict accordance with ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, and additional attributes of Complete, Consistent, Enduring, and Available) ensuring readiness for archiving and audit processes.
- Compile and analyze Quality metrics translating data into actionable insights to inform decision-making.
- Recommend and implement changes to processes procedures and training programs to continuously improve quality and compliance standards.
Here's What You'll Need (Minimum Qualifications)
- Minimum of 5 years of relevant experience in a regulated laboratory environment, with 2 years of supervisory or management experience within drug development at a pharmaceutical, biotech, or CRO.
- Master's/Bachelor's degree in a scientific discipline such as Biology, Chemistry, or a related field.
- Knowledge in clinical sciences and technology is required.
- Extensive experience in laboratory operations and compliance within a regulated environment (e.g., CLIA, CAP, GCLP).
- Proven track record of leading quality initiatives and internal audits.
- Strong understanding of regulatory requirements and quality management systems.
Here's What You'll Bring to the Table (Preferred Qualifications)
- Exceptional leadership skills and the ability to drive cross-functional collaboration.
- Excellent communication skills, both written and verbal, with the ability to influence and engage stakeholders at all levels.
- Previous experience leading, reviewing, and managing governance documents, access, and archiving to vault highly preferred.
- Meticulous attention to detail, organizational ability, clinical judgment, and good communication skills.
- High proficiency in MS PowerPoint and MS Project, excellent writing skills, organizational skills, and attention to detail.
- A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.
- This position is site-based, requiring you to be at Moderna's site full-time. This position is not eligible for remote work.
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
About Moderna
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 modernatx.com/careers 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 leavesandaccommodations@modernatx.com. (EEO/AAP Employer)
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