Associate Director, Quality Systems Corporate and Development Quality
Biopharmaceutical company focused on improving patients’ lives by identifying, developing, acquiring and commercialising differentiated and accessible medicines that address unmet medical needs.
The company has a portfolio of medicines through its orphan and inflammation groups. The company’s global headquarters are in Dublin, Ireland. The company also has offices in the US and Europe.
This position is responsible for the implementation and maintenance of the corporate quality systems, including controlled document management, learning management, change management, deviation management and corrective and preventive action (CAPA) management. Additionally, oversight of the product complaint system is included in the responsibility.
The position involves interaction with colleagues at all levels of management as well as external service providers and contract resources. The individual is expected to exhibit strong compliance values and organizational leadership. The individual will be a leader within the Corporate Quality department, which provides direction and support to business through a comprehensive Quality System.
This position will provide strong leadership and strategic direction to our quality organization as well as building the quality culture within the company.
- Ensures functional budgets and resource targets are assessed and managed to enable departmental targets to be achieved.
- Establish and manage Quality Management System to ensure visibility to quality and compliance to:
- Veeva Systems, Veeva Vault, QMS, VMS
- Oversight of the electronic document control and training systems
- Quality Management Reviews
- Collection and reporting of quality metrics
- Administer as BSO electronic Quality Systems, such as Veeva, ComplianceWire
- Provide guidance, interpretation and information pertaining to current GMPs to apply updates to the Quality System
- Monitor and inform others of changes to established quality systems standards, regulations and guidance. Provide consultancy on related quality/compliance/regulatory issues.
- Host inspections/audits, as assigned.
- Ensure appropriate responses and resolutions to quality system related inspection/audit findings are agreed and implemented.
- Establish and monitor global compliance processes (CAPA, Deviations, Field Actions, Change Control)
- Provide long range strategic planning of Quality System related activities
Qualifications and Skills Required:
- At least ten years experience in a quality role within a pharmaceutical development or manufacturing setting is required. A bachelor’s degree in Pharmaceutical Sciences, Chemistry, Biology, Engineering or related scientific discipline is expected. An advanced degree is desirable.
- Minimum of three years direct management level experience is necessary.
- Areas of expertise: Quality, Compliance, GxP, Regulatory.
- Working knowledge of drug development processes and associated FDA/EMA/ICH regulations and guidelines.
- Demonstrated ability to define and implement procedures which ensure compliance to GxPs (particularly GMP, GDP, GCP and GVP).
- Ability to travel approximately 20% on average, including trips abroad.
For immediate consideration apply with an up to date CV. Not sure yet? No CV ready? Get in touch for more info.
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