The Opportunity:

In this position you will be responsible for leading Data Integrity Programs and Strategy at the Group level. An Expert in DI regarding implementation of processes, procedures and practices to assure alignment with regulatory expectations. This position will also be responsible for leading Data Integrity activities, and monitoring of quality issues to assure reliability and health of the Quality System elements, as well as identifying events or trends that require investigation and improvement.

KEY RESPONSIBILITIES:

• Together with Sr. Quality Management develop strategic direction and approach for Data Integrity.
• Develop a detailed tactical plan for Data Integrity implementation
• Ensure fostering of Data Integrity awareness and culture at all levels of the company
• Define and rollout Data Integrity SOPs and supporting tools
• Develop governance and establish cross-functional DI community. Lead and work cross-functionally to understand, prioritize and mitigate DI risks. Lead the remediation of data integrity gaps and manage the ongoing status/progress reporting;
• Proactively contribute in a hands-on fashion to the timely investigation and resolution of DI problems;
• Support investigations, reviews and audits related to DI;
• Performs data integrity gap assessments for paper-based and computerized systems processes in production, R&D, IT and quality control as required
• Support regulatory inspections and responses to observations, including preparatory activities for upcoming inspections, related to DI;
• Collaborate, mentor with and train other team members in all departments to ensure Data Integrity is understood and embedded within the organization.
• Ensures compliance with quality system(s) and SOPs implemented
• Ensures compliance with international (US FDA, MHRA, EMA) regulations.
• Works with the group to roll out industry best practices (e.g. ISPE, PDA, etc.).
• Help to develop the Group Data Integrity strategy, in cooperation with site representatives creates the site specific data integrity plans, in adequacy with the phase and activities of the respective entities (QC, R&D, Manufacturing).

COMPETENCIES:

• Experience as an SME during EMA/FDA inspection is required;
• Extensive knowledge of cGMP’s is required with specific knowledge of Data Integrity and industry best practice
• Experience with data and computer technologies incl. databases, either integrated or standalone, in a QC/Production/IT environment preferred;
• A proven track record of influencing management, resolving complex compliance issues, and delivering on business results is preferred;
• Excellent communication (verbal and written), leadership, influencing & negotiating and collaboration skills in a fast-paced project environment are essential;
• Strong decision making and analytical skills and the ability to manage multiple projects at the same time is required;
• Ability to network and communicate with various functions and strong business acumen.
• Ability to travel (<10%), this position will be located in Loughrea, Galway
• Excellent knowledge of GMP requirements and pharmaceutical laws and regulations related to pharmaceuticals, especially in an EMA/FDA regulated environment.
• Strong organizational and project management skills
• Strong leadership, influencing and communication skills
• Ability to work adapt to the company and local culture
• Experience in Quality Systems Management

QUALIFICATIONS:

• University degree in Science or a related discipline.
• Minimum 10 years of pharma/biopharma industry experience
• 5 years in Quality Assurance within a cGMP manufacturing environment, EMA or FDA regulated.
• At least 3 years of management and or project management experience.