Manager, RDQ Digital Quality - Norwood, United States - Moderna
Description
The Role:
Reporting to the Associate Director, E_Data (CSV) Quality, located at Moderna in Norwood, MA, the Manager of Digital Quality, applies established knowledge and experience in systems validation and lifecycle.
The Manager should be familiar with global Health Authority Regulations including US FDA, ICH and guidelines (GAMP, Computer Systems Used in Clinical Investigations, etc.) and is responsible for the oversight, review, and approval of GCP/GLP/GVP-related computer system validation activities with a focus on quality support over GcLP internal validation activities of computerized systems/instruments/equipment, research computer systems vendor audits and internal system audits.
The Manager will also partner with R&D to create a quality culture within Moderna, provide business support, process improvements and inspection support as needed.
This position may interact with regulatory agencies and corporate partners during inspections and audits, and it will require travel for auditing vendors.
Here's What You'll Do:
Lead and co-lead internal and vendor computer system audits related to GCP/GLP/GVP systems including but not limited to pre/post audit meetings, agenda, partnering with key stakeholders, review of legal contracts and vendor/internal processes ensuring systems are developed, validated, managed, and controlled based on applicable regulations and guidelines.
Work closely with the Digital Technology department, system owners and business owners to implement new systems/instruments/equipment effectively and efficiently, system upgrades, or system modifications.
Review and approve computerized system, GcLP laboratory instruments, and GcLP equipment-related documents and procedures.
Support regulatory agency inspections as needed.
Participate and actively engage in strategic initiatives which require CSV support.
Provide support and input into the full CSV and SDLC program.
Contribute to the continuing development of a quality culture at Moderna.
Perform other tasks as assigned by the line manager.
Here's What You'll Bring to the Table:
BS/BA with 8 to 10 years of experience or MS with 5 to 8 years of experience in the pharmaceutical/biotech industry with experience in the R&D Computer Systems Validation GCP/GLP/GVP environment.
Demonstrated ability to work in a risk-based CSV environment following the associated regulatory expectations.Knowledge of Software Development Life Cycle (SDLC) principles including planning, analysis, design, development, testing, implementation, and maintenance is required.
Experience and practical understanding of the development and validation of custom GAMP category 5 software, modules, interfaces, and reports is desired.
Practical understanding of GAMP and ERES standards and guidance.
Understanding and familiarity with FDA & European regulatory requirements, guidelines, and recommendations for validation expectations (understanding of regulatory guidelines for other countries a plus), CFR 21 Part 11.
Demonstrated knowledge and/or prior experience in Quality Assurance and oversight of GVP systems such as Argus and Signal Detection.
Outstanding communication skills (verbal and written)
Ability to manage multiple projects in a fast-paced environment.
Ability to collaborate effectively in a dynamic, cross-functional matrix environment.
Ability to make decisions that are guided by policies, procedures, and business plan; receives guidance and oversight from manager.
Relies on experience and judgment to plan and accomplish goals.
Excellent organizational skills and keen attention to detail.
Travel Requirements (as a %)
Travel up to 30% based on business needs.
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:
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.
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 make a request to the Talent Acquisition Partner or contact the Accommodations team at.
(EEO/AAP Employer)
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