Leadership Manager

3 days ago

Sydney, New South Wales, Australia beBeeReliability Full time $100,000 - $150,000

The Role Overview:

This is a key leadership position in our organization, playing a crucial role in ensuring compliance and regulatory adherence.

Key Responsibilities:

  • GxP Compliance & Quality Management:
    • Collaborate with the Account Chief Engineer to ensure engineering services meet GxP requirements and regulatory standards.
  • Asset & Maintenance Management:
    • Implement Asset Management strategy across all sites in alignment with Account Chief Engineer's direction.
  • Technical Leadership & Engineering Operations:
    • Provide daily technical direction to site engineering teams, vendors, and contractors.
  • Client & Stakeholder Engagement:
    • Serve as the primary site-level technical point of contact for stakeholders.
  • Risk Management & Reliability Engineering:
    • Execute reliability engineering strategies to minimize equipment downtime.

Requirements:

- Bachelor's degree in Mechanical, Electrical, or Facilities Engineering

- Demonstrated engineering experience in pharmaceutical or medical device environments

- Strong working knowledge of GxP standards, validation principles, and quality management systems

- Experience managing compliance audits and CAPA investigations in regulated facilities

- Proficiency in CMMS and technical documentation systems

- Proven track record in reliability-centered maintenance and engineering risk mitigation

- Experience supporting ISO 13485, ISO 14644, or similar quality systems

- Strong technical leadership skills with ability to influence across organizational boundaries

- Detail-oriented with focus on compliance and procedural adherence

- Data-driven decision-making and problem-solving skills

- Excellent communication skills with ability to translate technical concepts to various audiences

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