Commercial Quality Head

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. Learn more at jnj.com.

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.

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About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https://www.jnj.com/innovative-medicine

Johnson & Johnson, Janssen Cilag is recruiting for a Commercial Quality Head, located in High Wycombe – UK.

The position serves as cluster lead of quality and compliance and oversees the Market Authorisation Holder requirements for licensed products in the UK and Ireland. 

As a Commercial Quality Head:

The Commercial Quality Head UK is responsible for the implementation and maintenance of a Quality Management System for pre and post marketing regulated activities and ensures in collaboration with the various leads of regulated functions (e.g. local safety officer (PV), Head of Regulatory, Medical affairs, etc) that the implementation meets the requirements of J&J Innovative Medicine Quality Policy and that all applicable and global, regional and local regulations are met.

The Commercial Quality Head UK maintains the Commercial Quality processes and systems to ensure the daily availability of high-quality products and services in the UK and Ireland markets.

The responsibilities and the impact YOU will have:  

Define and implement the UK and Ireland LOC quality strategy in line with regional Commercial Quality and local business strategies

• Identify and lead strategic and tactical continuous improvement opportunities. Carry out strategic planning on a continuous basis.
• Provide leadership, oversight and strategic guidance for significant regulatory compliance issues across the operating companies.

Proactively partner with commercial and other LOC functions to ensure quality aspects of new launches, delisting and divestures are managed appropriately.

 2.      Lead risk management and quality oversight

• Develop and drive improvement in the Quality System specifically Quality System Management Review, CAPA, Internal Audit, Escalation, Trending, Risk Management, Quality Planning and Failure Investigation.
• Serve as LOC lead on de-risking programs gathering appropriate input to ensure commercial business risks are being addressed and mitigated.
• Report metrics, key performance indicators. Work with LOCs to develop recovery plans, provide guidance and oversight to ensure recovery plan commitments are delivered.

3.      Maintain a compliant quality management system

·      Deliver the Quality System Management Review for UK and Ireland, providing in-depth analysis of quality data.

·      Obtain and maintain the required certificates, licenses and quality agreements for the local operating companies.

·      Accountable for in country product release by acting as or appointing a ‘Responsible Person for importation’.

·      Act as or ensure availability of a ‘Responsible Person’ on wholesale dealer authorizations.

• Perform quality system due diligence and integration activities as required by the business
• Partner on the formulation of responses to JJRC and regulatory agencies to address QMS related observations. Collaborate on the identification and implementation of corrective actions. Ensure effective and timely completion of all corrective actions and related commitments.
• Standardize and leverage compliance policies, practices and metrics across the LOCs in alignment with cross sector best practice and enterprise standards. 
• Ensure emerging regulatory requirements are addressed in a proactive and effective manner. Maintain current knowledge of regulatory changes through industry publications, seminars, professional affiliation and industry meetings.  
• Responsible for the compliant complaint management process and any other activities that ensure product quality requirements are met.

4.      Engage and collaborate with relevant stakeholders to meet Commercial Quality and business objectives

• Responsible for the compliant complaint management process and any other activities that ensure product quality requirements are met.

·       Establish effective collaborations with other quality departments such as R&D Quality, External Quality and Supply Chain Quality to ensure reliable product supply that meets regulations.

·       Work with functional partners (Local Medical Safety, Regulatory Affairs, Customer Service, Regional Demand & Supply) to ensure alignment of quality initiatives with strategic business direction.

• Responsible for the compliant complaint management process and any other activities that ensure product quality requirements are met.

·       Identify and sponsor local initiatives/projects to increase compliance and to reduce the impact of non-quality non-conformance.

·       Engage actively with external regulatory authorities, including performing lead and support roles as required for UK and Ireland LOCs during Internal Audits, JJRC Audits and external inspections

5.      Lead the Commercial Quality team in UK and Ireland

• Ensure effective recruitment/organizational development and succession planning for all direct reports.
• Perform financial planning and overall budget management.

·      Deliver results by inspiring and mobilizing people and teams while adhering to the values of the Johnson & Johnson Credo.

·      Empower the team to act with speed, agility, and accountability.

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

 Education:

• Bachelor's degree in life science or engineering, Master's degree is preferred.

Experience and Skills:

Required:

• Extensive experience in a highly regulated industry, including pharmaceuticals or medical devices.
• People leadership experience, preferably in an Emerging Markets context.
• Excellent communication and influencing skills.
• Applying digital tools and capabilities to optimize business processes.

Please note that our office will be relocating to central Maidenhead from October 2026. Applicants should ensure that this location is suitable for them.

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