Reporting to the Sr. Director, the Associate Director of Global Quality Computer Systems Validation (CSV) will be responsible for collaborating with the Digital group and cross-functional stakeholders to lead and drive support and harmonization of CSV activities. The individual will partner cross-functionally to ensure robust processes and systems are implemented and maintained to govern Global Quality requirements for CSV and ensure QMS system and other applicable GXP systems’ validation deliverables are executed and reviewed in a timely and compliant manner. This individual will have proven validation management experience in a biotech or pharmaceutical development environment and proven experience managing Global Quality Management Systems validation.
Here’s What You’ll Do
Set Global Policy and expectations for Computer Systems Validation
Provide oversight for Global System CSV activities; Provide input into, author, revise in creation, support and maintenance of CSV and IT related SOPs, work instructions, and forms.
Oversee contract validation specialist support
Participate in cross-functional QMS validation project initiative teams
Ensures schedules, and QA deliverables and requirements are met
Represent QA CSV on specific projects, and participate/support the planning, development, and implementation of computer systems validation documentation. Provide input into development of scope, actions and timelines.
Ensure review and audit computerized system validation deliverables according to 21 CFR Part 11, Annex 11 and other regulatory requirements deliverables - such as: user requirements functional requirements, validation plans, IQ/OQ/PQ documentation, risk assessments, test scripts, trace matrix requirements, deviations, validation summary reports, decommissioning reports and system use documentation (system admin, user admin procedures)
Provide leadership and guidance to and collaborate with local, cross-functional teams to accomplish company objectives and team goals including but not limited to on-time completion of system go-lives and enhancements
Lead and Manage continuous improvement efforts for the computerized systems validation program; Identifying opportunities to drive efficiency in GXP Operations
Escalate any issues appropriately to Head of Global Systems and Strategy
Provide support for GxP regulatory inspections as needed, including acting as subject matter expert
Review and approve change control and IT/Digital Change Control records and Periodic Reviews for Computer Systems
Here’s What You’ll Bring to the Table:
Bachelor degree, preferably in Sciences or Engineering with applied Quality industry experience of 10-15 years; 8-10 with MS.
Working knowledge of relevant FDA, EU regulations and ICH standards/guidelines and experience in supporting successful regulatory inspections.
A proven track record of success in implementing and maintaining quality systems and e-systems in a biopharma organization.
Ability to interact effectively with all levels of personnel within the organization.
Proven ability to lead and manage projects/teams of significant scope and complexity, while meeting all deliverables and timelines.
Excellent interpersonal skills using a team-oriented approach to project management and problem solving for complex issue resolution in a scientifically sound and understandable way.
Outstanding communication skills (verbal and written).
Ability to navigate through ambiguity and rapid growth and adapt to change.
Ability to be agile and effectively collaborate in a dynamic, cross-functional matrix environment.
A ‘digital first’ and curious mindset that allows you to constantly learn and challenge the status quo.
VEEVA EDMS/QMS experience, a plus.
Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:
Candidates should be aware that Moderna currently maintains a policy requiring all US-based employees to be fully vaccinated against COVID-19 and receive a booster shot once eligible. Newly hired employees must be vaccinated and boosted prior to their employment start date. Moderna is an equal opportunity employer and will provide a reasonable accommodation to those unable to be vaccinated or receive a booster where it is not an undue hardship to the company to do so as provided under federal, state, and local law.
In over 10 years since its inception, Moderna has transformed from a research-stage company advancing programs in the field of messenger RNA (mRNA), to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across seven modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for rapid clinical and commercial production at scale. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. Most recently, Moderna's capabilities have come together to allow the authorized use and approval of one of the earliest and most effective vaccines against the COVID-19 pandemic.
Moderna's mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and autoimmune diseases. Moderna has been named a top biopharmaceutical employer by Science for the past seven years. To learn more, visit www.modernatx.com.
Moderna is a smoke-free, alcohol-free and drug-free work environment.
Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.#LI-AG1