Commercial Quality Senior Specialist Surgery - UK in Reading

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

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.

We are searching for a Commercial Quality Senior Specialist within Surgery in the UK, who will be responsible for carrying out Commercial Quality activities to support the SURGERY organization in developing and maintaining an effective Quality Management System (QMS) for the UK/Ireland Local Operating Company (LOC).

The responsibilities and the impact YOU will have:

• Ensure compliance to all applicable quality standards & regulatory requirements in UK/Ireland LOCs and associated Distribution Centers.
• Drive simplification & standardization of QMS in line with J&J/ Surgery strategies & initiatives.
• Own, track and conduct non-conformances and CAPA investigations and document in the appropriate systems using approved tools.
• Establish and implement corrective & preventive actions to mitigate potential or remediate actual non-conformances.
• Perform Internal audits as per the UK/Irl or EMEA schedule.
• Embed QMS principles in the organization & drive continuous improvement.
• Work to the requirements of European and national Medical Device, Medicinal Product where applicable.
• Ability to work alone but part of a virtual team.
• Support site audits (e.g. from regulatory bodies, corporate audit teams etc.).
• Be an EMEA Subject Matter Expert to support the CQ EMEA team as required.
• Manage & lead change control activities as applicable.
• Manage/implement the Supplier/Distributor/POLO approval and monitoring program including supplier audits, as applicable.
• Create inputs for management review process and quality planning.
• Lead and/or participate in quality/compliance/regulatory projects.
• Manage/implement the Training Program, as applicable.

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

• B.Sc. in a Life Science or Engineering subject preferred.
• Experience in a primarily quality role within a high regulated environment (preferably Pharmaceutical or Medical Device) with knowledge of healthcare regulations.
• Experience of working with competent authorities and other regulators – preferred.

Core competencies required for this role:

• Excellent written and oral English communication skills.
• Good collaboration skills and ability to work independently with internal partners.
• Demonstrate Leadership behaviours expected by J&J Credo and Leadership Principals.
• Good System & Computer knowledge (Excel, Word, PowerPoint, Outlook, J&J systems).
• Customer focus for both internal and external customers.
• Integrity and Credo-based Actions - The ability to build trust.
• Results and Performance Driven- The ability to deliver business results and solutions.
• Collaboration and Teaming- The ability to work well across functions and groups.
• Positive attitude, well organized with attention to details.
• Have a sense of urgency.
• Demonstrates a digital mindset and interest in leveraging technology, data, and automation to drive process optimisation and innovation.
• Promote a proactive compliance driven culture of quality based on the 5 quality principles.
• Ensure timely and consistent escalation of events.

This is what awaits YOU at J&J: This is an opportunity to work with a ground-breaking biomedicine operation and to be a member of a Johnson & Johnson company, with an excellent record in employee continuous professional development and business improvement. We are passionate about our work; we play vital roles across a range of professional disciplines, and care deeply about our customers and communities. At Johnson & Johnson, our culture enables dynamic and impactful careers.

Whether you’re one of the people who already work here, or you’re considering joining the team, we offer:

• An opportunity to be part of a global market leader.
• A dynamic and inspiring working environment.
• Opportunities to work on challenging projects and assignments.
• Possibilities for further personal and professional development/education.
• Excellent benefits.