Assures quality products and processes, and Quality Standard Compliance by establishing, enforcing and maintaining quality MAP and compliant QMS. Establishes and maintains a permanent improvement process of the QA Organization and of the Quality System. Ensures the full compliance of QA activities with FDA, QSR, ISO 13485, Corporate Policies and other quality system requirements. Management of QA staff, and be the Management Quality representative inside and outside the plant (Competent Authorities / Notified Bodies, etc). Be an active and effective part of the Management team of the Site.
Under direct supervision of the Senior Director of Quality Assurance & Compliance (Europe) and with a dotted line to the Plant Manager, in the Ireland Site
- Ensure that all aspects of the operational business in the site comply with cGMP legal and regulatory requirements as well as Group Quality Manual and Policies.
- Provides direction, management support and leadership for QA/FDA remediation plans to insure compliance with FDA, QSR, ISO 13485, Corporate Policies and other quality system requirements.
- Ensure that compliance and quality risks are understood and are always integral part of business decisions.
- Establish and follow QA training program for the whole site.
- Support and supervise QA upgrade projects, harmonisation and ensure compliance with current standards.
- Implement a supplier QA program for the suppliers and sub-contractors associated with the Ireland products, including performing & co-ordination of supplier audits.
- Manage, support and supervise quality projects and ensure that quality problems and technical matters are resolved consistent with global standards.
- Liaises with Operations, PD, and others departments to prospectively plan QA support for project milestones.
- Organize and conduct external Inspections (FDA , Corporate) and follow their remediation plan.
- Strong project management skills, including the ability to prioritize, balance, and manage multiple efforts with strong results/goal orientation.
- Proactive, analytical and predictive mind-set to
- Ensure timely and complete site reporting, including relevant KPI and indicators.
- Drive continuous improvement and efficiency initiatives in Quality operations.
- Carry out other tasks or responsibilities as directed, to continuously improve Quality Assurance within the Company.
- Manage QA budgets.
- Revision of existing product documentation as required.
- Create Technical Bulletins, Label designs and Product User guides as required.
- Minimum BSc, preferably Master’s Degree in a scientific or engineering discipline or equivalent with 8-10 years’ experience or more in the medical device or pharmaceutical industry, strong analytical skills, exceptional writing and interpersonal relationship skills.
- Demonstrated knowledge of EU regulations, FDA regulations, ISO 9001, ISO 13485:2003, CMDR, Medical Device Directive Regulation (93/42EEC) and other National and International regulations and standards.
- Demonstrate ability to increase value delivered by team through Performance management and successful challenging of underperformance.
- Strong project Management skills with a proven track record of successful execution of major programs
- Strong Leadership skills with a tested and proven desire to motivate individuals, and hold team members accountable for performance.
- Experience in Process Excellence tools is highly desirable
- Excellent communication skills (verbal and written) in particular clearly communicating any changes in corporate requirements and financial analysis and the ability to build and maintain relationships at all levels in the organization
- Demonstrated planning excellence, developing action items that lead toward the accomplishment of long term goals by balancing short and long term objectives.
- Problem Solving - takes an energetic and proactive approach to anticipating and preventing problems. Uses sound reasoning to arrive at conclusions and put permanent fixes in place.
- Attention to detail to ensure accuracy and consistency of key plant data.
- People Management – demonstrated ability to motivate team to achieve Plant goals and promote professional development.