Location: Cork Role: Permanent

Details:

Quality Operations Process and Compliance Director with a leading Global Pharma Company. As part of a Global team the Quality Operations (QO) Process and Compliance Director will be responsible for coordination and execution of QO Operating Process Compliance. This role will be a key driver for organisations Quality vision and to execute at a global level across sites and functions quality objectives, metrics and operating mechanisms. You will report directly to the Executive Quality Operations.


Job Description

Essential Responsibilities

Drive priority Quality/Compliance programs and projects across the sites ensuring consistent project delivery and standardised process deployment;
Influences 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 support for Supply Chain Capacity Programs for both internal growth and integration of new collaborations and partnerships;
Owns the Quality Lean Culture and is accountable for driving critical KPIs and Product Quality improvements to improve 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.

Experience

Bachelor's degree and significant business experience in QA roles in the Pharmaceutical or Medical Device industries;
Demonstrated experience with applying classic Quality tools
Experience interfacing global regulatory agencies and governmental regulators;
Demonstrated ability to lead teams across sites;
Ability to detect trends or shifts in requirements and align or shift the internal priorities and actions accordingly;
Influencing/advocacy-able to determine a position and argue it effectively within the business context;
Strong project management and prioritization skills, ability to effectively manage multiple tasks and priorities;
Strong ability to guide change with global, cross-functional teams;
Proven ability to drive operational excellence;
Knowledge of and exposure to manufacturing or engineering processes.