Global Operations Leadership Team Accountabilities

• Resource Management:
  • Plan workloads, monitor capacity, and proactively address resource gaps across Hubs and Delivering Offices (DOs).
• Performance Accountability:
  • Drive global team performance against targets in chargeability, utilization, productivity, timeliness, assessment quality, and regulatory compliance.
• Stakeholder & Conflict Resolution:
  • Lead proactive decision-making to resolve operational and technical issues with minimal escalations and delays.
• Technical Guidance & Alignment:
  • Act as the primary technical reference point, ensuring consistent interpretation of regulatory requirements and internal procedures across the team, DOs, and Hubs.
• Performance Culture & Monitoring:
  • Set clear expectations and goals, monitor progress, and implement corrective actions as needed.
  • Conduct annual appraisals for existing staff and 3-month/6-month reviews for new team members.
  • Apply the performance management and disciplinary process as required.
• Business Growth Support:
  • Assist in proposals, client interactions, training, and external engagements to drive operational and financial targets.
• Process & Training Leadership:
  • Lead the development and maintenance of technical procedures, guidance documents, and training materials.
  • Upskill team members and external stakeholders on regulatory and internal requirements.

Key Accountabilities (Critical Focus Areas)

Regulatory Compliance & Assurance

• Ensure full compliance with:
  • SGS NB 1639 procedures
  • Company Code of Integrity, Secrecy, and Non-Disclosure Agreements
  • Applicable medical device regulations (MDR, IVDR, MDD, ISO 13485, etc.)
• Validate technical documentation assessments under relevant conformity assessment schemes.
• Monitor and address regulatory gaps, ensuring timely and accurate compliance.

Team Leadership & Performance

• Perform annual/appraisal reviews for all team members.
• Monitor KPIs (chargeability, utilization, productivity, timeliness, assessment quality) and implement improvement plans.
• Oversee disciplinary actions when required, ensuring fair and consistent application.

Health & Safety Compliance

• Adhere to company health and safety policies in all interactions with colleagues, clients, and external personnel.

Required Skills & Knowledge

Technical Expertise

• In-depth knowledge of:
  • Medical Device QMS systems (ISO 13485)
  • Sterilization techniques (microbial monitoring, packaging integrity, validation)
  • Regulatory frameworks (MDR, IVDR, MDD, UK MDR, ISO 13485 standards)
  • Conformity assessment procedures (NB evaluation criteria)
  • SGS NB 1639 standard and associated Best Practice Guides
• Ability to draft regulatory reports, audit findings, and technical dossiers.
• Experience auditing medical device manufacturers (QMS, sterilization, and technical documentation).
• Cross-functional team leadership skills (preferably in a global, distributed environment).

Soft Skills

• Excellent interpersonal and communication skills to engage with SGS teams, clients, and regulatory bodies.
• Problem-solving and decision-making with a focus on expert-level analysis.
• Training and mentorship skills to develop technical competencies in sterilization.
• Proactive, results-driven mindset with the ability to identify process inefficiencies and propose solutions.

Experience Requirements

Essential

• >10 years in the Medical Device industry, including:
  • ≥5 years in sterile medical device development, manufacturing, or sterilization (specialising in microbial monitoring, packaging integrity, and sterilization validation).
  • 5 years’ experience as an MDR/IVDR Lead Auditor or Product Assessor (Sterilization) within a Notified Body.
• 2+ years in a leadership role, demonstrating:
  • Technical decision-making
  • Expert-level problem-solving
• Experience in competence management, training, or qualification of technical personnel.
• Proven ability to lead or support global/cross-functional teams.

Desirable

• Experience navigating independent authority initiatives (self-motivated, structured approach to work prioritisation).
• Familiarity with SGS internal processes and QMS systems.
• Prior experience in a Notified Body or comparable regulatory environment.
• Training development experience (e.g., technical procedures, regulatory guides, or employee upskilling).
• Professional certifications in sterilization science or medical device compliance (e.g., CE Product Assessor, Lead Auditor diplomas).

Qualifications

• Degree or equivalent certification in:
  • Microbiology (or related studies: Pharmacy, Medicine, Engineering, Biological Sciences).
• Technical Manager – Sterilization candidate must have or previously held:
  • MDR Product Assessor certification
  • MDR Lead Auditor qualification

Preferred Training Background

• Product-specific training (e.g., ISO 13485, ISO 14971, sterilization method standards).
• Directive-specific credentials (e.g., 93/42/EEC, 98/79/EC, Regulation (EU) 2017/745).

Why Join SGS?

✅ Global stability & leadership in the Testing, Inspection & Certification (TIC) industry. ✅ Flexible schedule with hybrid/remote flexibility. ✅ SGS Campus & University for continuous learning opportunities. ✅ Multinational team, collaborating with colleagues across 6 continents. ✅ Comprehensive benefits platform.

At SGS, we champion **innovation, collaboration, and continuous improvement**. Join our **inclusive and supportive** workplace where you can **grow professionally and develop personally**.