Senior Director of Quality and Compliance

1 week ago

Cork, Cork, Ireland beBeeCompliance Full time €90,000 - €110,000
Job Title:

Director of Quality and Compliance

Job Description

The Director of Quality and Compliance will play a critical role in ensuring the highest standards of product quality and regulatory compliance at our state-of-the-art manufacturing facility.

This leadership position will be responsible for developing, designing, and maintaining quality and regulatory compliance across all aspects of our business, including electronic systems, data integrity, and GxP computerized systems.

The selected candidate will work closely with cross-functional teams to ensure that all systems meet global regulatory expectations and are aligned with corporate and regulatory standards.

Key Responsibilities
  • Implement Global CS and DI Quality Standards
  • Provide Quality Direction and Governance for QA-owned e-systems
  • Develop and Maintain Quality Assurance Procedures, Policies, and Systems
  • Conduct Routine Self-Inspections and Monitoring Assessments
  • Participate in IT and Quality Organizations
  • Perform and Support Data Flow Mapping for Production, Analytical, and Site-wide Processes
  • Ensure Accurate Documentation of Quality Records, Validation Activities, and System-related Compliance Data
  • Oversee System Change Control, Deviation Management, CAPA, and System Periodic Review Processes
  • Investigate and Address Deviations, Non-Conformities, and CAPA to Maintain Quality
  • Develop and Implement Comprehensive Data Governance Frameworks
  • Lead Data Mapping and Flow Assessments Across Lab, Manufacturing, and Support Functions
  • Collaborate with Data Owners and Functional Teams to Establish and Monitor Data Integrity KPIs
  • Perform Risk Assessments and Inspections to Identify and Mitigate Data Integrity Vulnerabilities
  • Provide QA Oversight for Manufacturing (MES, DeltaV, DCS), Laboratory (LIMS, ELN, and Benchtop Instruments) and Logistics Systems (SAP, EWM etc.)
  • Ensure Systems are Qualified, Validated, and Remain in a Compliant State per Regulatory Expectations
  • Support Automation Initiatives and Integration with Enterprise Systems
  • Review and Approve System Validation Documents
Requirements

Education:

A bachelor's or advanced degree in Science, Engineering, Computer Science, Quality or a related discipline is required. Advanced degrees (e.g., MSc, PhD) are desirable.

Experience:

10+ years with leadership in quality, compliance, data governance, and lab systems validation and quality assurance is required.

Skills:

Strong working knowledge of FDA, EMA, HPRA, MHRA, and other regulatory authorities for data integrity, CSV, Quality Risk Management (QRM) and biopharmaceutical regulatory requirements is required.

Deep understanding of lab systems such as LIMS, CDS, ELN, and instrument software validation is required.

Proficiency with validation frameworks (e.g., GAMP 5), risk management, and audit readiness is required.

Exceptional communication, cross-functional leadership, and decision-making abilities are required.

Benefits

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form for further assistance.

Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

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