Quality Operations Process and Compliance Director
Job Summary:
In this key leadership role, the Quality Operations Process and Compliance Director will coordinate and execute quality operations processes across global sites and functions. This position is responsible for driving priority quality and compliance programs, influencing the Quality Operations Leadership Team, and overseeing the Quality Lean Culture.
Key Responsibilities:
* Drive priority Quality/Compliance programs and projects across sites to ensure consistent project delivery and standardised 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 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.
Requirements:
* Bachelor's degree in a relevant field 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.