Loughrea, Loughrea Municipal District, Ireland · On-site
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 inte…
Skills: QA Compliance, Audit Management, Data Integrity, Quality Risk Management, Pharmacovigilance
Loughrea, Loughrea Municipal District, Ireland · On-site
Basic Role Summary: The QC Compliance Officer is responsible for ensuring that all Quality Control laboratory activities comply with applicable regulatory requirements (e.g., EU GMP, FDA, ICH) and internal quality standa…
Skills: Quality Control, Regulatory Compliance, GMP, FDA, ICH
Loughrea, Loughrea Municipal District, Ireland · On-site
Basic Role Summary: This is an opportunity to be part of a dynamic team within the QA function. We are looking for individuals who will support and drive Chanelle Pharma’s vision to be the most valued global provider of …
Skills: Supplier Quality Management, Compliance Documentation, Vendor Performance Management, Risk Assessment, Change Management
United Kingdom · Remote OK
Working closely with the UK Commercial Team, Finance, and Commercial Operations, the UK Pricing & Rebate Executive will play a critical role in supporting commercial performance through robust pricing analysis, rebate ma…
Skills: Pricing Analysis, Rebate Management, Financial Reporting, Data Analysis, Stakeholder Management
Amman, Amman, Jordan · On-site
BASIC SUMMARY: An important role in the QA department, reporting to the QA Compliance Team leader, the Compliance Specialist will be responsible for reviewing and issuing of Product Quality Review and provide a Regulator…
Skills: Organizational Skills, Time Management, Communication Skills, Collaboration, Strategic Decision-making
Loughrea, Loughrea Municipal District, Ireland · On-site
Basic Role Summary: We are a pharmaceutical organisation undertaking a major digital transformation, migrating our core business processes onto SAP (S/4HANA). The Data & Analytics Lead is a pivotal role at the heart of t…
Skills: SAP S/4HANA, Data Governance, Business Intelligence, SAP Analytics Cloud, Power BI
Ballinasloe, Connacht, Ireland · On-site
This is an opportunity to be part of a dynamic team within the warehouse function. We are looking for individuals who will support and drive Chanelle Pharma’s vision to be the most valued provider of high quality, compet…
Skills: Picking and Packing, Cycle Counting, GMP Compliance, Inventory Management, Health and Safety
Loughrea, Loughrea Municipal District, Ireland · On-site
Basic Role Summary: A key role within the QA department, reporting directly to the QA Compliance/Qualified Person, the Validation Officer is responsible for the review and issuance of validation protocols and reports. Th…
Skills: Validation Documentation, Document Control, GMP Compliance, FDA Requirements, Change Control
Loughrea, Loughrea Municipal District, Ireland · On-site
Basic Role Summary: The Technical Trainer designs, delivers, and evaluates technical training programs to ensure employees achieve and maintain the required levels of competence in line with regulatory, quality, and safe…
Skills: Technical Training, GMP Compliance, Data Integrity, Analytical Techniques, HPLC
Sign up with Clera and we'll reach out the moment a role actually fits you — no more spraying applications into the void.
The QA Compliance Team Lead will manage the site's inspection readiness, audit programs, and data integrity initiatives. They are responsible for leading the compliance team, overseeing quality risk management, and ensuring adherence to GMP and pharmacovigilance standards.
Candidates must hold a degree in Quality Assurance, Pharmaceutical Science, or a related life science discipline. A minimum of 5 years of experience in a GMP-regulated QA compliance role, including at least 2 years in a leadership capacity, is required.
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.
Chanelle Pharma is a global pharmaceutical leader in human and animal health. As an end-to-end, fully integrated partner, the company serves B2B, consumers, and wholesale markets, combining development, manufacturing, and commercialisation under one roof. Chanelle delivers reliable services across the full product value chain, provides immediate access to a broad product portfolio, and drives growth through strategic partnerships. With operations in Ireland, the UK, Portugal, and Jordan, the company supplies high-quality, reliable, and affordable products to more than 90 countries, underpinned by a commitment to innovation, sustainability, and differentiated customer value.
Offices: Dublin Road, Loughrea, Co. Galway, IE · Chanelle Medical, Lower Unit 1 High Street, Hungerford, Berkshire RG17 0DN, GB · Amman, JO
Chanelle Pharma is a global pharmaceutical leader in human and animal health. As an end-to-end, fully integrated partner, the company serves B2B, consumers, and wholesale markets, combining development, manufacturing, and commercialisation under one roof. Chanelle delivers reliable services across the full product value chain, provides immediate access to a broad product portfolio, and drives growth through strategic partnerships. With operations in Ireland, the UK, Portugal, and Jordan, the company supplies high-quality, reliable, and affordable products to more than 90 countries, underpinned by a commitment to innovation, sustainability, and differentiated customer value.
Offices: Dublin Road, Loughrea, Co. Galway, IE · Chanelle Medical, Lower Unit 1 High Street, Hungerford, Berkshire RG17 0DN, GB · Amman, JO
