Associate Director/Director Inspection Management
- BBBH784495 Jun 09, 2021 Competitive
An Associate Director/Director is required to lead Inspection Management in a global Biopharmaceutical company based in Limerick.
This stand alone role sits on a Global team and reports directly to the Executive Director of Quality.
This individual will provide support during regulatory inspections and internal audits. The successful candidate will also work to ensure that all identified content is organized, current and readily accessible in the event of an inspection or audit purposes. Additionally, the individual will work with department leaders to build an inspection readiness capability across the organization.
The role can be broken down into Inspection Readiness and Execution. A typical day in each area might include the following:
- Benchmark leading practices and recommend improvements to make the site inspection-ready at all times.
- Maintain and organize inspection readiness content, including building and maintaining a content repository, to ensure quick access to materials in the event of inspection or audit.
- Build and implement tools to improve inspection readiness.
- Identify trends in recent regulatory inspections and translate this to recommendations to enhance readiness.
- Work closely with other regulatory compliance teams to close gaps and improve inspection readiness capabilities.
- Liaison with regulatory bodies, partners and key suppliers on audit, regulatory, and quality related matters and to provide guidance and advice to partners, suppliers and internal associates on regulatory and quality matters.
- Respond to incoming inquiries during inspections and audits and ensure timely and accurate responses.
- Ensure marketed products are in compliance with global regulatory and guidance requirements primarily US and secondarily EU.
- Define and implement quality standards, systems, and metrics for maintaining regulatory compliance for clinical and commercial operations.
- Interfaces with customer/partner quality organizations.
- Participates on internal committees/teams, as required.
- Provides advice and direction to other company departments on quality and regulatory issues.
- BA/BS degree in a relevant discipline
- As an Associate Director level you must have at least 10 years of relevant experience and for Director level 12 years of relevant experience. The majority of this experience needs to be within the Biotechnology field.
Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.
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