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IT Quality / Validation

Location: Burlington, Massachusetts
Job Category:

Location: Burlington, MA--MAX 117 an BR

Duration: 6+ Months

I put together the following job description for the role Vadim was filling, and I have highlighted critical areas for the current project:

Job Summary (The Role)

Experienced collaborative consultant will serve as the CSV SME to provide compliance and project management expertise as a member of cross-functional teams, and ensure that GxP computerized and automation systems are in full compliance with regulatory requirements, company policies and procedures throughout the full SDLC. This consultant will also collaborate with business partners to maintain and improve CSV compliance.

Responsibilities (List Essential Functions and Duties)

·         Manage project teams, create project plans and task lists to align project stakeholders in delivering compliant validated GxP computerized systems.

·         Ensure delivery of projects within determined schedule, scope, and budget constraints.

·         Change control for internal and external (SaaS) GxP computerized systems.

·         Oversee and review external vendor validation activities and audits.

·         Manage external vendors during projects and ongoing operation phase.

·         Collaborative creation and/or review efforts with System Owners, QA and IT for GxP computerized system deliverables including but not limited to vendor audit plan, vendor audit report, validation plan, risk assessment, impact assessment, installation qualification, operational qualification, performance qualification, protocol summary reports, validation summary report, user requirements, functional specification, design specification, configuration (technical) specification, data migration plan, workflow diagrams and user acceptance test.

·         Revise SOPs


Basic Qualifications

·         A minimum of 10 years of Regulated system experience, preferably in life sciences, biopharma or related industry.

·         Bachelor’s Degree (B.A./B.S.) or equivalent experience.


Preferred Qualifications

·         MBA or other relevant graduate degree preferred.

·         Deep knowledge of GXP compliance as relates to IT governance, 21 CFR part 11, data integrity, and computerized systems validation in SaaS cloud-based environment.

·         Ability to incorporate compliance into scalable policies and procedures, harmonizing requirements across compliance domains as appropriate (Sarbanes Oxley, MA 201, etc.).

·         Experience leading change control processes, system development lifecycles, and a release management cycle for regulated systems.

·         Ability to manage a portfolio of projects, activities and tasks simultaneously and autonomously.

·         Experience with validated ERP systems, eTMF and EDC systems, quality management systems, safety systems, eCTD submission systems and regulatory communication platforms.

·         Strong communication and interpersonal skills.

·         Entrepreneurial, enjoys working in a fast-paced, small-company environment.

·         High levels of organization, attention to detail, and accuracy.

·         Proactively identifies business needs and identifies process or technology solutions.

·         Strong written and verbal communication skills

·         Fosters a collaborative environment and incorporates diverse perspectives in order to manage change effectively.




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