We Make Life More Rewarding and Dignified
Job Summary
A member of the global Quality Leadership Team, this position will provide Quality leadership for the Ostomy, Continence Care, Distribution and Supplier/Contract Manufacturing Quality Teams to achieve business objectives. They will strive for a dynamic Culture of Quality to continuously improve our products, processes and Quality Management System (QMS) to best fulfill our Mission and Vision and make life more rewarding and dignified for the people who use our products.
Key Responsibilities
* Provide Quality Assurance leadership to the facilities Quality Managers at our Global operation locations as well as Distribution Quality, Supplier Quality and Contract Manufacturing groups.
* Responsible for ensuring quality assurance related processes and products are compliant with all applicable regulatory requirements and standards.
* Responsible for the oversight, measuring (KPIs) performance and continuous improvement of the processes within responsibility
* Drives continuous improvements initiatives to the highest standards of quality assurance, quality control and supplier management for world class products.
* Collaborate with manufacturing & Plant Quality Assurance Manager(s) to ensure achievement of existing quality levels of manufactured products and seek methods to continually improve quality outcomes including leading on cost of quality initiatives.
* Drives cross site standardization of similar processes and test methods related to quality operations when appropriate and in compliance with regulatory requirements.
* Develops risk-based sampling strategies aligned with regulatory requirements,
* In conjunction with QLT, develops and executes an overall strategy for QA function ensuring communication to key stakeholders for alignment.
* Fosters a Culture of Quality within the team and cross functionally.
* Ensures appropriate support is provided during internal and external audits/inspections.
* Responsible for maintaining professional development plans and coaching of all direct reports including annual goal setting.
* Makes decisions with respect to product quality in consultation with key stakeholders.
* As part of Hollister's Global Quality Leadership Team (QLT), the position holder will attend QLT meetings as required .
* Develops and advises on the continuous improvement of quality system processes and procedures. Maintains a healthy quality system for sites of responsibility.
* Built effective communications at all levels while displaying active listening skills.
* Leverages leadership in change management and risk assessment for process / product changes.
* Advises and participates in IT solutions for quality system improvements.
* Ensures training is provided pertaining to good manufacturing practices (FDA, ISO and MDSAP countries)
* Where required, acts as liaison with all regulatory agencies including FDA, HPRA and notified body NSAI as needed.
* Responsible for achieving competency in all identified skill requirements outlined in associated training profile for position.
* Performs other duties and tasks as assigned.
Essential Functions of the Role:
Communication/Leadership
* Management of Talent Development and Employee Engagement
* Budget Management
* Strategic Planning and Deployment
* Ability to interface with a computer for a long period of time
* Public speaking requirements
* Constant utilization of listening skills, both person to person and over the phone
Work Experience Requirements:
* Number of Overall Years Necessary: 12-15
* Minimum of 8 years' experience in a Regulated industry with Demonstrated Quality Assurance leadership, preferably in the medical device industry. Plant experience in a Quality management role required. Corporate experience in a senior management leadership role with domestic/international plant responsibility preferred. Experience handling facility regulatory inspections (i.e. FDA, notified body) preferred.
Education Requirements:
* Bachelor's /Third Level degree in Quality/Science/Engineering or a related discipline is required.
* Advanced degree is desirable.
Specialized Skills/Technical Knowledge:
* Extensive experience working in Medical Devices.