Are you an experienced Compliance Manager with a strong background in Quality Management and internal auditing? Do you have the leadership and influencing skills to drive compliance in a dynamic, regulated manufacturing environment?
I am seeking a tenured Compliance Manager to join our established GMP manufacturing facility. In this critical role, you will lead internal audit programs, assess quality system compliance, and influence key stakeholders to ensure regulatory alignment and operational excellence.
Key Responsibilities:
- Lead Internal Audit Programs: Develop, plan, and execute internal audits to assess compliance with regulatory and corporate quality system requirements.
- Influence and Partner with Stakeholders: Engage with cross-functional teams, senior management, and regulatory agencies to drive a culture of compliance.
- Regulatory Readiness: Facilitate external inspections from regulatory bodies (e.g., FDA, BSI) and manage the response process to findings.
- Strategic Compliance Oversight: Communicate compliance status through Quality System Review meetings and provide insights for continuous improvement.
- Quality Leadership: Provide direction to quality teams, ensuring adherence to policies and procedures while fostering a proactive compliance culture.
- Training & Development: Identify gaps in compliance knowledge and contribute to the creation of effective quality tools and training materials.
- Process Improvement: Identify and implement more effective audit tools, methodologies, and corrective action strategies.
Qualifications & Experience:
- Minimum of 6+ years in quality, compliance, or auditing within a regulated manufacturing environment (GMP preferred).
- Auditing Expertise: Demonstrated experience in conducting internal audits, assessing compliance risks, and implementing corrective actions.
- Influencing & Leadership: Strong ability to influence, engage, and partner with senior management and cross-functional teams.
- Regulatory Knowledge: In-depth understanding of GMP, FDA, BSI, and other relevant regulatory frameworks.
- Strategic Thinking: Ability to anticipate compliance trends, drive proactive improvements, and align activities with corporate objectives.
- Problem-Solving & Decision-Making: Strong analytical skills to assess complex compliance issues and make informed decisions.
This is a great opportunity to shape and enhance the compliance culture of a well-established GMP facility and work in a dynamic environment with a team of quality and regulatory professionals.
If you are a compliance-driven professional with strong auditing skills and the ability to influence and drive change, I would love to hear from you. If you would like to find out more about this role please click the 'Apply Now' button below or reach out to Kellie on 021 2300 300.
