CQ Lead and RP Surgery UK/Ireland in Wokingham

About Surgery

Fuelled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Are you passionate about improving and expanding the possibilities of surgery? Ready to join a team that’s reimagining how we heal? Our Surgery team will give you the chance to deliver surgical technologies and solutions to surgeons and healthcare professionals around the world. Your contributions will help effectively treat some of the world’s most prevalent conditions such as obesity, cardiovascular disease and cancer. Patients are waiting. Your unique talents will help patients on their journey to wellness.

As a CQ Lead And RP Surgery UK/Ireland, under the general direction of the Senior Director Commercial Quality, this position is responsible for establishing and leading Johnson & Johnson's overall quality management framework and quality system for the country/cluster, establishing preventive and corrective actions to mitigate potential or actual non‑compliance risks and ensuring compliance to attain world‑class operational/customer focused capabilities. The overall management responsibilities also require exerting leadership in regional projects and initiatives providing strategic direction to achieve established goals.

The Responsibilities And The Impact YOU Will Have:

• Manage Quality Systems
• Lead the Cluster/Country Commercial Quality organization, including handling, storage, distribution, Level 2 (in-country) customer Service, Technical Service and Repair, and commercial activities, to ensure a proactive approach to quality assurance and quality systems.
• Act as Quality Management Representative as per ISO13485/ISO9001/QMS definition, as applicable.
• Develop appropriate strategic and process performance measures/targets such as delivery service issue management.
• Manage the overall corrective and preventive action (CAPA) and risk management processes.
• Establish and maintain global and local relationships with partnering organizations and regulatory bodies.
• Oversee the management of Standard Operating Procedures, ensuring simplicity, standardization, and education across the cluster/country.
• Ensure compliance to all applicable quality standards and regulatory requirements.
• Ensure troubleshooting and solutions to quality issues through statistical analysis and process excellence tools.
• Ensure timely escalation of Quality or Regulatory Compliance Issues.
• Present case studies and metrics to Cluster/Country Leadership.
• Coordinate/guide execution of internal audit, and external party audit as needed.
• Propose initiatives for quality performance improvement.
• Drive complaint vigilance execution in the countries, where applicable, ensuring the timely closure of product related complaints cases, quality, and immediate escalation.
• Understand current requirements of Regulatory Agencies such as local MOH’s, as well as, of standard organizations such as ISO.
• Ensure compliance with the J&J policies and local regulations at LOC, the local warehouses and distributors, including external partners.
• Liaising with other functional areas as appropriate in the execution of these tasks.
• Establish proper surveillance of the distribution activities (cold chain and loaner kits).
• Effectively work with Cross Segment leadership (functional and commercial) in the deployment and sustainability of initiatives that will support QMS execution and compliance on designated countries.
• Management of Pharmacovigilance and Post Market Surveillance systems within the country/cluster in compliance to local regulations.

Strategy and Planning:

• Develop a common vision and strategy for Quality and Process Improvement.
• Entrench a process improvement culture within the business.
• Implement process management practices, verify/validate project results and advocate further use of Process Excellence to drive business results.
• Embed QMS management principles in the organization, creating cross‑functional process improvement teams who effectively complete improvement projects central to these efforts.
• Engage all company employees in these initiatives, through interactive project coaching/consulting and change management strategies.
• Ability to represent the region in Local, Regional and Global forums, leading functional efforts as required to achieve results.

Relationship Management:

• Partner with the Country/Cluster, Deliver Operations, Regional and Functional Community, Business Leaders, Process Owners and Project Teams.
• Work with external business partners and regulators to build capability and ensure compliance to quality standards.
• Strengthen quality & compliance capability in the organization, through tools like trainings, newsletters, conferences, quality month.

Special Requirements:

• The CQ Lead serves as the Responsible Person (RP), and completes RP activities for Medicinal Products as required for LOC.
• Lead the Consignments and loans management process in EMEA within Commercial Quality EMEA team.

We would love to hear from YOU, if you have the following essential requirements:

• This strategic role requires a diverse business background, preferably with direct experience in multiple J&J segments and Corporate, with specific quality, regulatory and regulatory compliance competencies in the areas of: Sales, Marketing, MAKE, QMS, customer service, distribution and commercial customer interface.
• Experience in positions of increasing responsibility supporting large, multi‑site, global organizations, with broadly based quality management experience.
• Experience with the global demands of the role specifically: multi‑cultural / multi‑country locations and healthcare regulatory requirements.
• Proven success in strategy development and project management across the organization, with measurable, financial, quality and cycle time results.
• Understanding the linkages in quality and regulatory compliance from product development through manufacturing and delivery to customer and health authority.
• Driving alignment on strategy and approach across multiple differing health authority requirements.
• Builds consensus and impacts outcome without always having line authority and is able to negotiate trade off decisions across the organization.
• Inspiring and leading across extremely diverse organizations in terms of size, scope, and experience.
• Compliance experience, large‑scale QMS experience.
• Experience leading risk‑based oversight programs within a segment or Corporate.
• Change management and project management experience.
• Collaborative approach.
• Managing complexity.
• Strong analytical and strategic skills with a bifocal approach – ability to zoom‑in/zoom‑out for strategic and tactical, high‑level and detailed, etc.
• Previous experience interfacing with global regulatory agencies, e.g., FDA, MHRA, TGA, notified bodies, etc, and a history of success and credibility resolving complex regulatory compliance issues.
• Audit Management experience (Health Authorities, Notified Bodies).
• Experienced as audit lead (ISO 9001 and/or ISO 13485 or equivalent).
• Track record of developing people, leading or coaching teams and driving results.
• Recommended experience of Process Excellence.

Education:

• Bachelor’s or Master’s degree in Bioscience, Engineering or Business or equivalent field coupled with relevant business experience in Quality leadership roles, significant years working experience in the Medical Device Industry, Extensive years working experience in quality/regulatory function.

Core Competencies Required For This Role:

• Decisive, organized, and able to lead people within a complex social, cultural and political environment.
• Must have excellent communication skills, able to inspire trust and quickly build credibility within the Quality & Compliance, Supply Chain, and Commercial organizations.
• Strong presentation skills.
• Experience working in a global or regional context would be desired.
• Must have strong collaboration and influence management skills to partner effectively across functions and operating units.
• Proven track record of engaging organization and demonstrating collaboration across the organization at all levels.
• Hands‑on operational orientation.
• Accountability, with a strong desire to commit, be held accountable and be rewarded for delivering results.
• Recognizes and builds support for change.
• Engages in constructive conflict.
• High tolerance for ambiguity in a complex environment.
• Makes the complex clear and easily understood by others.
• Strong relationship development, conflict resolution, and team building instincts, with the ability to build partnerships both internally and externally.
• Makes the customer central to all thinking.
• Ability to fit in well culturally in a complex organization.
• Fluent in local language (for country roles).
• Fluent in English.
• Demonstrates an understanding of AI concepts and frameworks, including awareness of responsible and ethical AI practices, and has experience generating effective prompts to boost efficiency and productivity.

Job location:

• For UK/IRL: UK (Pinewood). Please note that our office will be relocating to central Maidenhead from October 2026. Applicants should ensure that this location is suitable for them.

Preferred Skills:

• Compliance Management
• Continuous Improvement
• Corrective and Preventive Action (CAPA)
• Developing Others
• Fact-Based Decision Making
• Give Feedback
• Inclusive Leadership
• ISO 9001
• Leadership
• Performance Measurement
• Quality Control (QC)
• Quality Management Systems (QMS)
• Quality Processes
• Quality Standards
• Standard Operating Procedure (SOP)
• Team Management