An exciting opportunity has arisen for a seasoned Quality Systems Manager to join a global leader in its field to develop design and validation strategies for new and existing products. Using a broad understanding of the business and working knowledge of functions within it, the successful candidate will provide inspiration and leadership to project teams developing and implementing strategies on significant global projects as well as new product introductions. This role requires a working technical skill as well as significant leadership experience.Responsibilities
- Recruits, trains, motivates and manages the performance of technical and operational quality professionals in line with divisional and personal objectives.
- Provide leadership, inspiration, and direction to project teams delivering design, development, and validation of new and existing products, processes, facilities, utilities, equipment, materials and software in line with business needs and maintaining compliance with the division/corporate policies/worldwide quality and regulatory standards.
- Project manage quality systems improvement program by leading cross-site/functional teams against the project schedule and budgets.
- Lead the training and document control process ensuring cross-site/divisional alignment as well as compliance with the division/corporate policies/worldwide quality and regulatory standards.
- Represent the site as a generalist for internal/external auditors and regulatory bodies for any matter relating to quality or audit response.
- Establish, implement and maintain the effectiveness of the quality system on-site in accordance with ADC divisional requirements and applicable regulations. This includes compliance to FDA, QSR, ISO13485, EU IVD, FireSafetyHealth regulations, UK employment authorities and other regulatory bodies.
- Create, implement and maintain site validation plan to ensure compliance. This involves interfacing across all site departments including R&D, Operations, Technical & QA Management to set strategic direction on the validation approach for the process, software systems, facilities, utilities, equipment, cleaning and test methods.
- Maintain process expertise in the department for all 7 disciples of the validation (Process, Software, Facilities, Utilities, Equipment, Cleaning and Test Method).
- Manage the review and approval of all validation packages on-site such that all quality records comply with regulatory requirements.
- Manage EHS within the department taking action to minimise hazards and risk.
- Set and manage team budget and financial performance for the technical quality organisation of $6 million.
- Collaborate across the site to ensure cross plant consistency in the manufacturing process.
What we offer
- Educated at degree level preferable MSc in a related field, technology, quality or engineering discipline.
- Demonstratable experience in design and validation.
- Demonstratable leadership experience both direct and indirect.
- A natural leader who is passionate about developing processes and people.
- Competitive Salary
- Attractive benefits package