Associate Director QA Compliance

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Associate Director, QA Compliance

Our Client are looking to recruit a QA Compliance - Associate Director, who will play a lead role in our quality team on site.

This role will manage a team of Quality Assurance Specialists and Senior Specialists. They will be responsible for all people aspects, such as coaching, talent development, recruitment and performance management.

This position is critical to ensure sustainable compliance of site processes, procedures and systems with our Manufacturing Division requirements and regulatory requirements and expectations.

The successful candidate will manage the following activities:

* Serve as primary contact for regulatory agency inspectors. Lead the development of responses, CAPA implementation and effectiveness checks.

* Manage the site auditing program.

* Ensure recalls are executed as decided and appropriate agencies and contacts are notified in accordance with defined procedures.

* Ensure that all regulatory commitments and related reporting are generated and submitted to the appropriate department or Regulatory Authority in accordance with established procedures.

* Verify data and information in regulatory submissions and regulatory responses for quality, integrity and accuracy.

* Manage site quality agreements with external and internal partners in line with established procedures. Contribute to the creation of quality agreements for multiple sites or on global level for such quality agreements that are relevant for the site.

* Ensure that a system is in place to manage CAPA activities including generation, investigation, documentation, implementation, verification, closure, effectiveness, and trending.

* Ensure that a system is in place to manage complaints handling and investigations and ensure its effectiveness.

* Oversee and manage all data integrity activities of the site.

Education:

* Third level qualification (Degree) in a Science or Technical related discipline

* Project Management qualification such as, Project Management Professional.

* Evidence of Continuous Professional Development.

* Preference for Lean Six Sigma Green Belt

Experience:

* Minimum of 10 years' experience in the FDA and/or EU regulated pharmaceutical environment; preferably in a manufacturing site in quality and/or manufacturing roles, which includes significant leadership roles with experience in a front-line supervisory role in operations environment.

* Demonstrated in-depth knowledge of global health authority regulations and quality and compliance requirements with the ability to effectively communicate these requirements.

* Knowledgeable in Industry Best Practices for quality and compliance related topics.

* Strong collaboration and cross-functional leadership skills to drive continuous improvement and promote knowledge sharing and implementation of best practices across the site and Compliance functions on global and local level.

* Proven ability to effectively initiate and drive change across the site.

* Strong verbal and written communication skills, project management skills.

* Demonstrated ability to influence areas not under direct control to achieve objectives and effectively communicate challenging goals and objectives.

* Demonstrated ability to make and act on decisions while balancing speed, quality and risk.

* Ability to provide innovative ideas to improve quality and compliance that create value including seeking new information and external insights.

If you are interested in applying for this position please call Aoife on 01-6455251