Manager, Digital Quality Validation, R&D Quality

The Role

In this role, you will apply established knowledge and experience in computer systems vendor audits, systems validation, and lifecycle.  The Manager should be familiar with global Health Authority Regulations including US FDA, ICH and GAMP guidelines and is responsible for leading/co-leading computer system vendor and internal audits, and the oversight, review, and approval of internal GCP/GLP/GVP related computer system validation activities as needed. 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 meeting, 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.

• Manage audit related observations and CAPAs.

• Work closely with Digital Technology department, system owners and business owners to implement new systems, system upgrades or modifications effectively and efficiently.

• Participate in the change control program for modifications to qualified systems.

• Deliver strategy solutions to computer systems validation based on Moderna’s processes, industry guidance and regulations.

• Review and approve computerized system and validation 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.

• Travel expectations up to 30%.

• Additional duties as may be assigned from time to time.

Here’s What You’ll Need (Minimum Qualifications)

• BS/BA with 10 to 12 years of experience or MS with 8 to 10 years of experience in 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) principals 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 required.

• Validation of Artificial Intelligence (AI) computerized systems and processes is desired.

• Experience and proficiency with CSV audit for Research (GCP, GLP, GVP) computerized systems 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.

• Expertise with business office applications, word processing and spreadsheets.

• Demonstrated knowledge and/or prior experience in Quality Assurance.

• 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.

• This role is based in our new LEED-certified HQ in Cambridge, MA and is expected to be in office 70% of the time with flexibility to work from home up to 30%.

Here’s What You’ll Bring to the Table (Preferred Qualifications)

• BS/BA with 8 to 10 years of experience or MS with 5 to 8 years of experience in 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.