Job details
Job type full-time
Full job description
The srQuality specialist – it quality assurance, regulatory affairs and compliance (qarac) is responsible for performing an independent quality review and approval of validation/qualification documentation and assisting with the management of compliance programs for audits, periodic reviews, capa and deviations in alignment with company policies and government regulations.
The ideal candidate will have proven background with developing and maintaining it compliance programs in a gxp regulated environment, exhibit strong planning and organizational skills, provide excellent leadership, negotiation and mediation skills, and a demonstrated ability to work with all levels of the organization.
How will you make an impact?
You will contribute as a member of the it corporate solutions and integrations, quality assurance, regulatory and compliance (csi-qarac) team developing corporate compliance policies, procedures and programsYou will provide quality compliance guidance to the members of the csi-qarac team and build excellent business partnerships with corporate it, business quality and it organizations.
What will you do?
Review and approve computer system validation, infrastructure qualification, and change control activities (planning, documentation, testing, reports, etc.) for regulated global it systems.
Collaborate with peers in designing and maintaining quality systems for deviations, capa, training, and change management programs.
Collaborate with it qarac management, global quality, it partners and internal/external auditors on initiatives to drive compliance across the network.
Collaborate with peers in both it and the business groups to support regulatory and client audits.
Lead/actively participate in the it vendor/supplier qualification and management program.
Provide ongoing support for multiple quality-related technologies meeting agreed service level agreements and following it best practices and change management procedures.
Assist with the authoring and document management of corporate it standard operating procedures (sops).
Assist with the management of the training program and record management for global it staff.
Develop and implement team training for corporate it that meets regulatory requirements for gxp environments at scale.
Identify and deliver quality system metrics and report results to management.
Embody thermo fisher’s 4i values: integrity, innovation, intensity, and involvement.
Comply with company’s global it policies & procedures.
Perform all other related duties as assigned.
How will you get there?
Experience:
6+ years of experience working as a quality assurance representative in a fast-paced, large company gxp regulated environment.
Minimum of 3 years of experience working in a computer system validation or it quality assurance role.
Experience with qualification, validation, change control, auditing, periodic reviews, capa and deviation resolution/management.
Functional understanding of it infrastructure including basic networking, server operating systems, and active directory group policy objects.
Education:
Bachelor’s or master’s degree in life sciences, computer science, it, information systems management, or related field.
An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
Knowledge, skills, abilities
Knowledge with quality and it frameworks, approaches, tools, methodologies (i.e., gamp, iso, itil, sdlc, computer software assurance (csa) etc.)
Proven affinity and understanding of quality, regulatory and compliance best practices.
Must have an advanced understanding of the validation and qualification lifecycle and all applicable phases including planning, testing, reporting and change control.
Able to analyze and propose solutions for compliance issues and deviations.
Able to manage multiple priorities, projects, deliverables, and stakeholders.
Proven ability to work in an fda regulated (gxp), fast-paced, large company environment.
Able to work in a multi-disciplinary and geographically dispersed team.
Excellent interpersonal, verbal and written communication skills at all levels of the organization.
Experience in the use of application lifecycle management (alm) or other automated testing tools is desirable.
Knowledge of the agile software development processes is desired but not required.
