Associate Director of Technical Operations & Quality Compliance
Our Limerick based Bio-pharmaceutical client are hiring! You will be responsible for the management and leadership of the Technical Operations Quality & Compliance function, providing quality and compliance oversight and support to the Facilities, Engineering and Automation departments under the Site Technical Operations group. Sounds like a role for you?
- Responsible for the management and leadership of the Technical Operations Quality & Compliance team, including supervision, coaching, mentoring to direct reports and other compliance specialists as required
- Working in conjunction with leaders across other Technical Operations functions in all aspect of quality and compliance, in particular the management of quality instances through the quality systems including complex technical investigations, the oversight and performance monitoring of all quality and compliance related critical metrics, the development and delivery of an audit readiness program including the delivery of appropriate technical and regulatory focused training.
- Ensures team compliance with all departmental policies and procedures.
- Interface across the business with Quality Assurance, Manufacturing and other functional areas as part of cross functional investigations, responsible for critical decision making and setting out future in order to remove obstacles, resolve conflicts, and to help facilitate critical decisions pertaining to quality system deliverables.
- Define and implement quality standards, systems, and metrics for maintaining regulatory compliance for Technical Operations commercial operations.
- Continually reassess Facility, Engineering & Automation systems, procedures and processes for adherence to cGMP, Data Integrity regulatory requirements and industry best practices, implement changes/improvements as needed.
- Represent the Facilities department on various topics during regulatory inspections, and coordinate responses to inspection observations as applicable.
- Identify trends in recent regulatory inspections and translate this to recommendations to enhance readiness.
Education and Experience:
- Requires BS/BA in Life Sciences (or other technical/science field)
- Associate Director requires 10+ years experience in Quality Systems/Quality Compliance/Quality Operations role
- Director requires 12+ years in Quality Systems/Quality Compliance/Quality Operations role
- Experience in a Biopharma / pharma or other cGMP environment with 5+ years in a leadership role.
- Excellent technical, people management, analytical, negotiation and influencing skills are required
For further information on this role in please contact Mark Wilson on 0860449473 or email email@example.com
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