- Ensure the Quality Systems adhere to tight internal standard and including the Local / International regulatory bodies.
- Identify leading practices and recommend improvements to continuously improve compliance profile.
- Identify Trends in recent regulatory inspections and translate this to recommendations to enhance readiness.
- Work closely with other compliance teams to close gaps, improve practices and maintain compliance.
- Define and implement quality standards, systems and metrics for maintaining regulatory compliance for operations.
- Interface with Customers/partner quality organisations as required.
- Participates on internal committees/teams as required.
- Provides advice and direction to other company departments on quality issues.
- Provide support during inspections and audits.
Education and Experience:
- Honours Degree BS/BA in Life sciences or B. Eng. in Mechanical or Biomedical engineering (or equivalent), Master's degree a plus
- Min 8+ years of relevant progressive experience in QA within the Pharma / Biopharma Industry and some experience working with Global Regulatory Agencies.
- Proven experience leading teams of people in achieving company goals.
Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.
BY APPLYING FOR THIS ROLE YOU ARE AGREEING TO OUR TERMS OF SERVICE WHICH TOGETHER WITH OUR PRIVACY STATEMENT GOVERN YOUR USE OF MORGAN MCKINLEY SERVICES.