Digital Compliance Specialist

Digital Compliance Specialist will be a key player in our client’s Digital Compliance Projects in the regulated industries:

This position involves leading Digital compliance and validation activities often working cross-functionally with various department to ensure quality is met using a risk-based approach. If you are an experienced, result-driven leader, with extensive validation experience, this is the role for you! This is a full-time, permanent position in a growing consulting company with a great culture and environment that supports personal and professional growth.

Responsibities

• Development of project plans to support computerized system validation planning
• Development, review and/or approval of specification and verification documents as per CSV lifecycle documentation and deliverables
• Development, support and facilitation of change management process for computer and automation systems
• Analyze and perform assessments using a GAMP risk-based approach for changes on validated computerized systems impacting data integrity, hardware interactions and security, and assign appropriate levels of validation accordingly
• Evaluate testing procedures for continuous monitoring
• Investigate direct compliance issues
• Assess product, compliance, or operational risks and develop  risk management strategies
• Identify compliance issues that require remediation
• Communicate written policies and procedures across the organization
• Collaborate with senior management and the appropriate department heads
• Advise senior management and business partners about implementing compliance programs
• Review continuous monitoring and continuous documentation of systems
• Report compliance violations

Requirements

• B.Sc. in Engineering, Microbiology, Chemistry, Biotechnology or Biochemistry, or related scientific background
• 5-10+ years’ experience in Life Sciences/Regulated Industry compliance
• Project management certification (an asset)
• Lean Six Sigma certification (an asset)
• Strong Compliance experience (quality, CSV, DI, Annex 11, 21 CFR Part 11) in GxP regulated environment
• Excellent written and verbal communications (English and French), and strong interpersonal skills.
• Autonomous and able to work independently
• Confidence and ability to professionally present information to internal and external stakeholders.
• Project coordination/management expertise
• Attention to detail in the planning and monitoring of actions to carry out the tests and resolve the problems encountered
• Excellent problem solving and root cause researching skills

Additional Information

We are an equal opportunity employer.