Posted in Engineering 22 days ago.
This job brought to you by Professional Diversity Network, Inc
Type: Full Time
Location: Research Triangle Park, North Carolina
SummaryAs part of the IT Quality team, this Quality Analyst will deliver technically robust and compliant GxP computerized systems (CS) that withstand audits, both internal and external.Job DescriptionAs part of the IT Quality team, this Quality Analyst will deliver technically robust and compliant GxP computerized systems (CS) that withstand audits, both internal and external. The Sr. IT Quality Analyst is expected to have working-level knowledge of CS at the enterprise level, including the quality systems supporting it (i.e., change management, exceptions management, risk management). Foundational and executable regulatory expectations for CS. Works with peers locally and globally, when necessary to ensure practices are consistent with requirements and expectations set forth within the governing QMS. May support health authority inspections as a Quality SME within the space.
The Sr. Associate II, IT Quality will also be responsible for:
Driving the deployment of new or modified GxP systems through review and approval of life cycle deliverables in compliance with the governing regulations and procedures.
Working with senior members of the team, representing ITQ on cross-functional teams in support of SDLC activities for GxP applications - either enterprise platforms or functional specific applications.
Performing and managing all supporting quality related activities associated with computerized systems including periodic reviews, exception management (deviation / CAPA), change management, risk management, etc. for assigned systems in alignment with noted KPIs.
Supporting all Global Quality initiatives, including Data Integrity, Computerized Systems and IT QMS implementation / remediation.
Performing all assigned and required trainings to maintain 100% compliance.
Support GxP audit readiness activitiesQualificationsA minimum of ten (10) years related experience and/or training with 5 years in a CSV / Quality role. Background in Lifesciences and/or Pharma/Biotech industries. Additionally:
* Experience supporting implementation of computerized systems within a GxP environment either as a CSV and/or Quality lead.
* Understanding of key compliance components as it relates to computer systems validation
* Ability to complete complex tasks independently
* Ability to interpret regulatory guidance (GxP) and Biogen policies and procedures into executable and defendable lifecycle documentation
* Knowledge of respective regulations governing computer systems and controls such as 21 CFR Part 11, Annex 11, MHRA's data integrity guidance, etc.
* Understanding of risk-based methodologies as it relates to CSV and general Quality practices
* Experience supporting health authority inspections, a plusEducationBachelor's degree in Life Sciences, Engineering or IT related discipline with relevant experienceAll individuals deserve the right to achieve their full potential. Accordingly, our company welcomes all job applicants, and we strive to provide all employees with equal opportunity for advancement. We will not tolerate any form of discrimination or harassment based on an individual's sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information, or any other basis protected by local government agencies or law.As an employer of choice, we strive to:Provide attractive employment opportunities for diverse candidates at all levels and in all segments of our organizationPursue and maintain relationships with sources of diverse candidates, community organizations, and academic institutionsComply with both the letter and the spirit of all applicable laws and regulations relating to nondiscrimination and affirmative action in employmentVEVRAA Federal ContractorWe Request Priority Protected Veteran and Disabled Referrals for all of our locations