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Senior Manager, Data QC, Clinical Biomarker Laboratory
4 months ago
The Role:
The Clinical Biomarker Laboratory group at Moderna is seeking a Senior Manager to serve as a point of contact to support quality control activities associated with the growth of clinical phase studies run within the GCLP/ GLP regulated biomarker laboratory. The Data QC senior manager will provide quality support and guidance related to laboratory activities and will play an integral role in the identification and management of quality issues with support from the compliance group. This role has responsibilities for leading the quality control initiatives and enforcing procedures for the upholding of quality standards toward excellence.
This position reports to the Associate Director for GxP Lab Compliance at the Clinical Biomarker Laboratory (CBL) teams and is a part of Moderna's Clinical Assays and Supply Logistics group. This position is required to be on-site 5 days a week.
Here's What You'll Do:
* Develop analytical quality data standards related to GLP/ICH/ GCP in accordance with existing SOPs across clinical studies and in collaboration with Laboratory Operations lead and scientific leaders at CBL.
* Responsible for gathering Quality data required to establish metrics and generate insights and daily oversight of the Data Quality procedures in place.
* Evaluate performance, risks, and alignment with current regulatory expectations.
* Serve as a cross-functional lead for key initiatives relating to Quality metrics and reporting.
* Collaborate with study personnel to ensure documentation review and corrections are complete throughout regulated studies and during QA audits.
* Act as Document Coordinator to track version changes of controlled documents, and distribution and training of new versions.
* Assist with maintaining the master schedule.
* Assist with development or revisions of SOPs
* Lead Quality analytics processes and develops analysis procedure and reporting mechanisms to improve GxP compliance.
* Support QC review/approval of clinical data generated from biomarker assays through analytical and cell-based assay methods.
* Participate in review of protocols, methods, reports, batch records and related GLP/GcLP source documents to actively manage data and documents by using various software like Excel, LabVantage LIMS (Laboratory Information Management System) database, and Veeva for clinical phase studies.
* Produce training manuals for the scientific and technical staff to ensure best practices are implemented.
* Collaborate with QA team and other functions towards the continued evolution of the Quality Management System (QMS) and execution of risk-based management solutions.
* Coordinate with internal and external groups to identify appropriate solutions to improve on clinical data analysis and
* Operate at a consistent and exemplary level of efficiency, producing high quality and accurate results, in a fast-paced environment.
Here's What You'll Bring to the Table:
* Bachelor's / Master's/ PhD degree in Pharmaceutical Sciences or related industry with strong background in quality data analytics
* 4 to 8 years of relevant clinical laboratory experience in pharmaceutical industry or CROs
* Knowledge in various lab-based techniques such as immunoassays, cell-based assays, cytometry, and other platforms for the investigation of biomarkers in clinical phase studies.
* Knowledge of Bioanalytical, cytometry method validation for Industry is preferred.
* Knowledge of data management tools, and data integrity requirements such as with QC review of LIMS/ ELN/ LES system, RYZE, CDISC standard and data collection formats.
* Prior experience in Developing and maintaining study-specific data management documentation such as CRF Specifications, Data Management Plan, and Data Cleaning Plan documentation is preferred.
* Previous experience in working in GxP or CAP/ CLIA, GLP regulated laboratory is highly preferred.
* Hands-on experience and knowledge of quality systems and regulatory requirements (21 CRF Part 11/58)
* Previous experience in Lab management and Digital Automation are preferred.
* Proficiency with Microsoft Office Suite (Outlook, Excel, Word, etc.). Proficiency with statistical analysis methodologies is a plus.
* Attention to detail, organizational ability, judgement, team player attitude and effective communication skills.
* Demonstrated ability of multi-tasking
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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