Manager of Regulatory Excellence

1 week ago

Sydney, New South Wales, Australia beBeeCompliance Full time $110,000 - $130,000

We are committed to improving patient outcomes and making a positive impact on the world. Our compliance team plays a crucial role in ensuring seamless operations at our manufacturing plant and QA department.

The Role of Compliance Manager

As a key member of our team, you will be responsible for leading and managing compliance teams to deliver anticipated outcomes within required timelines.

Key Responsibilities
  • Manage and lead compliance teams to ensure regulatory standards and policies are met.
  • Guarantee that internal audits are accessible and effectively executed according to global quality policies and procedures.
  • Adhere to quality training matrices and relevant regulatory standards.
  • Maintain required licenses and certificates for our plant.
  • Coordinate supplier quality programs to align with global quality policies and regulatory requirements.
  • Manage corporate and external audits, providing timely responses and completing actions.
Requirements
  • Tertiary qualifications in science, engineering, pharmacy, or related fields.
  • Demonstrated application of good manufacturing practices (GMP) in a pharmaceutical manufacturing environment is highly desirable.
  • Proven experience in leading teams and implementing projects.
  • Understanding of build control principles and techniques.
  • Experience with Minitab and project management software.
  • Proficient computer skills, including statistical analysis, spreadsheets, word processing, and project management.
  • Prior working knowledge of Baxter-specific computer systems.
  • A keen eye for detail and ability to accurately document data and information.
  • Excellent verbal and written communication skills.
  • Ability to negotiate and collaborate effectively as part of a team.
  • High level of initiative and energy.

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