Life Sciences Compliance SME

Overview

Remote
$100,000 - $120,000
Full Time
No Travel Required

Skills

Agile
Incident Management
Management Consulting
Stakeholder Management
Change Management

Job Details

Life Sciences Compliance SME
Indianapolis, IN
Fulltime

Required Qualifications:

  • At least 6 years of Information Technology experience.

  • Strong Quality and compliance experience.

  • Performing on project teams and providing deliverables involving the evaluation of IT quality and GxP issues in an FDA regulated environment

  • Evaluating IT risk issues, including the use of data and technology to provide greater coverage, targeted precision and insight

  • Evaluating IT and business controls, including those relevant to GxP, IT quality and 21 CFR Part 11

  • Understanding of common IT risk domains, including cybersecurity, privacy, disaster recovery, change management and IT operations

  • Understanding of Corrective and Preventive Action (CAPA) issues management in an FDA regulated environment

  • OT System commissioning and Qualification (Radio ligand Therapy or critical dosage forms will be a plus)

  • Experience to MES, QMS (Track wise).

  • PAS/DCS Qualification.

  • ISA95 High level of understanding.

  • OT Security will be a plus.

  • PAS/DCS Integrated with Manufacturing Equipment qualification.

  • Stakeholder management and good executor with required communication.

  • Experience and desire to work in a management consulting environment that requires regular travel.

Preferred Qualifications:

  • Knowledge of Agile/Scrum as required for Validation.

  • Experience and desire to work in a management consulting environment that requires regular travel

  • Planning and Co-ordination skills

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.