Science & Research Jobs in Loughrea, Ireland (Now Hiring) — 17 open

Basic Role Summary:

To lead the QA Compliance function, ensuring the site maintains a state of inspection readiness and complies with all applicable regulatory requirements. This role oversees audit management, data integrity programs, quality risk management, pharmacovigilance quality assurance, and the internal self-inspection program.

Location: Onsite at our facility in Loughrea.

As our QA Compliance Team Lead, your key responsibilities will be as follows:

• Lead and develop the QA Compliance team to ensure high performance and engagement.

• Allocate resources and prioritize compliance activities to meet business and regulatory objectives.

• Maintain a state of readiness for regulatory inspections and customer audits.

• Plan, coordinate, and manage internal audits and external inspections, including preparation, hosting, and follow-up.

• Ensure timely closure of audit findings and CAPAs.

• Oversee implementation and monitoring of data integrity programs across all systems and processes.

• Ensure compliance with ALCOA+ principles and regulatory expectations for electronic and paper records.

• Lead the site’s quality risk management program, ensuring risk assessments are performed and documented appropriately.

• Provide guidance on risk-based decision-making and mitigation strategies.

• Ensure compliance with pharmacovigilance requirements and support audits related to PV activities.

• Collaborate with relevant stakeholders to maintain PV quality systems.

• Manage the site’s self-inspection program, including scheduling, execution, and reporting.

• Drive continuous improvement based on findings and trends.

• Identify opportunities to enhance compliance processes and implement best practices.

• Monitor regulatory changes and update compliance programs accordingly.

Qualifications and Experience:

• Degree in Quality Assurance, Pharmaceutical Science, Life Sciences, or related discipline.

• 5+ years in a QA compliance role within a GMP-regulated environment, with at least 2 years in a leadership position.

• Experience in audit management, data integrity, and risk management.

Skills and Competencies:

• Strong knowledge of GMP and regulatory requirements.

• Excellent organizational and leadership skills.

• Effective communication and stakeholder management.

• Ability to motivate and guide a team toward achieving compliance objectives.

• Commitment to maintaining high standards of regulatory compliance.

• Skilled in identifying and mitigating compliance risks.

• Ensures accuracy and completeness in documentation and processes.

• Works effectively across departments and with external stakeholders.

Applicants from diverse backgrounds, including those returning after a career break or with transferable skills from non-traditional career paths, are encouraged to apply. We value varied experiences and are committed to fostering an inclusive environment that supports individuals with disabilities.