Description
This position will assist in providing objective, independent a leading Generic pharmaceutical based in North Dublin is seeking a Global Quality Compliance Manager.Assurance that all global sites are operating in compliance with best practices and regulatory compliance requirements. A primary role of this position is the evaluation and implementation of standardized compliance and quality processes within the companies sites in route to sustainable compliance and all-time inspection readiness.
- Perform independent evaluations of quality systems and practices at the companies sites located around the globe taking into considerations national and international regulations as applicable (FDA, EMEA, TGA, Health Canada, WHO, PIC/S, MHLW, JP).
- Assist in the evaluation of global compliance metrics to determine trends and opportunities for continuous compliance and quality improvement.
- Identify potential problems and coordinate resolution to issues prior to their having an adverse effect on the established business.
- Provide guidance on quality/compliance improvement as needed to assure sites are always prepared for Regulatory Agency inspections.
- Prepare and maintain schedules, meeting agenda, and evaluation reports.
- Prepare executive summaries and reports based on evaluations conducted
- Stay current with industry standards and interpretations of key regulations.
- Efficiently coordinate travel in order to work within budgetary commitments while meeting global quality demands.
- Perform other duties as assigned by Management.
Here are the qualifications required for this position:
- Must possess a sound knowledge of applicable cGMP regulations and expectations sufficient to readily interpret, lead discussion, and provide guidance based on the applicability of the regulations to the subject being evaluated. Must be familiar with all other GXP concepts.
- Ability to read and interpret comprehensive and intricate GMP and research documents. Ability to write evaluation/audit reports and technical correspondence. Ability to work with peers, business contacts, and corporate management in order to communicate moderately complex concepts. Ability to present to groups.
- Must possess excellent communication and negotiating skills. Must be articulate in both written and oral communications including diplomatic discussion of required corrective actions with business partners. Must be able to review, interpret, and discuss governing regulations, precedent interpretations, and current application. Must be adept at independent decision-making. Must be proficient in leading discussions of complex topics and have a working knowledge of Microsoft Office including Word, Excel and Lotus Notes.
- Requires domestic and international travel (approximately 50% of the time).
If you are interested in this great opportunity and have the relevant skill set and experience please contact me Anna Mooney or reply with a up to date CV.