- execution of closed loop audit and assessment programs , including Technology Supplier Audit and GxP system Periodic Reviews.
- providing direct support to business segments during global health authority inspections and other third‑party audits related to Technology areas.
- compliance metrics analysis and communication of risk themes to drive systemic actions when appropriate.
- assists in the continuous improvement of the compliance programs, including external regulatory outreach to shape emerging regulations in the areas of technology and innovative healthcare solutions.
- reports to the Head, Med Tech & Emerging Compliance.
- Executes closed loop Supplier Audit and GxP System Periodic Review Programs, including conducting independent audits/reviews, providing independent oversight of audit planning, audit and assessment corrective actions, documenting results, reporting on follow‑up status, escalating critical issues/risk to senior leadership.
- Plan, organize and execute comprehensive audits of GxP software and/or software technology service providers.
- Partners with Technology Quality and Business Quality to execute gap assessments between current practices and new regulatory expectations.
- Works with Quality partners to establish corrective actions to address any identified gaps.
- Leads the resolution of complex situations that arise during execution of closed loop audit and assessment programs.
- Ensure awareness of industry standards, trends and best practices in order to strengthen GxP knowledge.
- Participate in industry and other professional networks to ensure awareness of industry standards, trends and enforcement actions.
- Provide compliance input and final review of formal responses to health authority observations related to Enterprise Quality Compliance.
- Provides compliance subject matter expertise and support to Technology Quality and sector Business Partners related to GxP processes in the end-to‑end technology areas.
- Proactively sense for opportunities and actively participate in compliance program development from the outset.
Requirements
- A minimum of a Bachelor’s or equivalent University degree is required.
- 3+ years of progressive experience in managing all aspects of Quality and Regulatory Compliance in an international, global context, in a regulated healthcare environment.
- Expert knowledge of Quality System regulations, ISO, ICH, PIC/S, and cGMP regulations, including Annex 11, 21 CFR Part 11, Part 210, Part 211 and Part 820, and how these apply to Computer Systems and software medical devices.
- Auditor experience in a regulated industry, preferably HealthCare Industry
- Expert knowledge of IT internal controls, SDLC methodologies, GAMP5, data integrity requirements.
- Experience effectively interfacing with global regulatory agencies, e.g., FDA, MHRA, TGA, notified bodies, etc.
- Experience interpreting regulations and translating regulatory requirements into practical strategies.
- Ability to resolve complex regulatory compliance issues.
- Ability to analyze and interpret regulatory documents.
- Proven experience in driving progress to strategic plans and remaining focused under ambiguous and complex situations.
- Excellent written and oral communication skills, including proven ability to make technical and complex topics clear and easily understood orally and in writing.
- Ability to effectively present information to executive management.
- Ability to lead teams and build strong cross‑functional relationships.
- Ability to influence, negotiate, and build credibility.
- Strong skills in interdependent partnering to facilitate collaboration.
- Audit management and delivery
- Analytical mindset
Core Competencies
Demonstrates expert knowledge of Quality System Regulations, ISO, ICH, and cGMP regulations, with a strong focus on GxP compliance in technology and healthcare. Proven ability to lead audits, manage regulatory compliance issues, and effectively communicate complex regulatory requirements to stakeholders.
Highest-signal resume keywords
- Quality System Regulations
- GxP Compliance
- Regulatory Agency Interaction
- Audit Management
- Data Integrity Requirements
ATS Optimization Keywords
Hard Skills
- GxP System Periodic Review
- Audit Planning
- SDLC Methodologies
- GAMP5
- Regulatory Document Interpretation
- Compliance Metrics Analysis
- Corrective Action Planning
- Risk Communication
- Quality Compliance Management
- Healthcare Regulatory Compliance
Soft Skills
- Excellent Communication Skills
- Influencing and Negotiation
- Cross‑Functional Collaboration
- Analytical Mindset
- Problem Solving
Industry Keywords
- ISO
- ICH
- PIC/S
- CGMP
- FDA
- MHRA
- TGA
- Annex 11
- 21 CFR Part 11
- Part 210