Quality Operations Process & Compliance DirectorLocation: Cork | Role: Permanent Details:The Quality Operations Process and Compliance Director will be responsible for coordination and execution of Quality Operations (QO) Process Compliance within a leading Global Pharma Company.
This role will be a key driver for the organization's Quality vision, executing quality objectives, metrics, and operating mechanisms at a global level across sites and functions.
You will report directly to the Executive Quality Operations.
Essential ResponsibilitiesDrive priority Quality/Compliance programs and projects across the sites ensuring consistent project delivery and standardized process deployment.Influence the Quality Operations Leadership Team to drive ownership of Product Quality and Compliance with local site and functional teams.Drive the QO Lean and Digital journey ensuring successful and timely system deployments.Support and provide technical assistance for Supply Chain Capacity Programs for both internal growth and integration of new collaborations and partnerships.Own the Quality Lean Culture and be accountable for driving critical KPIs and Product Quality improvements to enhance patient safety.Accountable for each of the metrics for the business (i.e., complaint investigation, internal audit score, product quality, employee engagement, etc.)
and management review process.ExperienceBachelor's degree with significant business experience in QA roles in the Pharmaceutical or Medical Device industries.Demonstrated experience with applying classic Quality tools.Experience interfacing with global regulatory agencies and governmental regulators.Proven ability to lead teams across sites.Ability to detect trends or shifts in requirements and adjust internal priorities and actions accordingly.Strong influencing and advocacy skills to effectively argue positions within the business context.Strong project management and prioritization skills, with the ability to manage multiple tasks and priorities effectively.Ability to guide change with global, cross-functional teams.Proven ability to drive operational excellence.Knowledge of and exposure to manufacturing or engineering processes.
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