Compliance and Governance Lead
2 weeks ago
TN Ireland is seeking an experienced Compliance and Governance Lead to join their team. As a key member of the organization, you will be responsible for ensuring the highest quality standards are met in our analytical testing processes.
Key Responsibilities- Develop and implement effective compliance strategies to ensure adherence to regulatory requirements.
- Lead the sourcing strategy for External QC, selecting contract laboratories for commercial testing, secondary transfers, business continuity management, and external network review.
- Design and deliver performance management and governance across the contract laboratory network.
- Maintain the Global QC Risk Register process, identifying and mitigating risks associated with contract laboratory performance.
- Support the preparation for Notification to Management meetings.
- Investigate significant issues affecting External QC, including root cause analysis, risk assessment, analytical technical support, and compliance support.
- Lead audit readiness for External QC, including preparation of audit content, data packs, storyboards, presenting to auditors, preparing team members to present to auditors and supporting audits.
Qualifications:
- Bachelor's degree or equivalent in Biological Sciences, Chemistry, or other biotechnical science.
- Minimum 10 years of laboratory experience in a GMP environment.
- Proven ability to work in a matrixed organization.
- In-depth understanding of current regulatory requirements for QC, including QC testing, data integrity, supplier management, method transfer.
- Knowledge of business and management principles involved in resource allocation and financial management.
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