Compliance Manager
We are seeking a seasoned Compliance Manager with a strong background in Quality Management and internal auditing to lead our established GMP manufacturing facility.
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.