Job Summary
CQ Lead & RP – Surgery UK & Ireland (Pinewood – relocating to Maidenhead from October2026). This role reports to the Senior Director Commercial Quality and oversees Johnson & Johnson’s quality management framework across multiple European regions.
Responsibilities
* Establish and lead the quality management framework and QMS for the UK & Ireland cluster and associated regions.
* Ensure execution of QMS requirements in line with local regulations, corporate policies and segment procedures.
* Act as Quality Management Representative (ISO13485/ISO9001) and manage CAPA, risk management and corrective actions.
* Develop and monitor strategic and process performance measures/targets and deliver metrics to leadership.
* Oversee the management of SOPs, ensuring simplicity, standardization and education across the cluster/country.
* Serve as a key business partner for quality and process improvement, applying statistical analysis and process excellence tools.
* Lead internal and external audit activities and coordinate the management review process.
* Drive complaint vigilance and timely field action execution, ensuring product‑related complaint closures.
* Liaise with regulatory agencies and ensure compliance with local and EU MDR requirements.
* Manage pharmacovigilance and post‑market surveillance within the country/cluster.
* Facilitate strategic planning and embed QMS management principles across the organization.
* Lead cross‑functional process improvement teams and advocate process excellence.
* Provide leadership during regional projects and initiatives, representing the region in global forums.
* Ensure proper surveillance of distribution activities (cold chain, loaner kits) and partner with cross‑segment leadership.
* Represent the cluster in local, regional and global quality committees.
Qualifications
* Bachelor’s or Master’s degree in bioscience, engineering, business or equivalent.
* Minimum 8–10years of quality, regulatory or compliance experience in the medical device or pharmaceutical industry.
* Proven experience with ISO 9001, ISO 13485 and QMS implementation across multiple regions.
* Strong knowledge of international regulatory frameworks (FDA, MHRA, EMA, etc.) and experience interfacing with health authorities.
* Demonstrated success in leading CAPA, risk‑based oversight and audit management.
* Experience in change management, process improvement and project management on a multi‑site, global scale.
* Excellent communication, presentation and stakeholder engagement skills.
* Fluency in English; local language proficiency if required.
* Strong analytical ability and strategic thinking.
Required Skills
* Compliance Management
* Continuous Improvement
* Corrective and Preventive Action (CAPA)
* DevOps in Quality Management Systems (QMS)
* Standard Operating Procedure (SOP) Development
* Team Management
* ISO 9001
* Performance Measurement
Preferred Skills
* Inclusive Leadership
* Development and Coaching
* Fact‑Based Decision Making
* AI Ethics and Prompt Generation
#J-18808-Ljbffr