Commercial Quality Lead & Qualified Person - UK

Commercial Quality Specialist & Qualified Person - UK

What we do

At Kenvue, we realize the extraordinary power of everyday care. Built on over a century of heritage and rooted in science, we’re the house of iconic brands - including NEUTROGENA®, AVEENO®, TYLENOL®, LISTERINE®, JOHNSON’S® and BAND-AID® that you already know and love. Science is our passion; care is our talent.

Who We Are

Our global team is ~ 22,000 brilliant people with a workplace culture where every voice matters, and every contribution is appreciated.  We are passionate about insights, innovation and committed to delivering the best products to our customers. With expertise and empathy, being a Kenvuer means having the power to impact millions of people every day. We put people first, care fiercely, earn trust with science and solve with courage – and have brilliant opportunities waiting for you! Join us in shaping our future–and yours. For more information, click here.

Role reports to:

Commercial Quality Lead, Ireland

Location:

Europe/Middle East/Africa, United Kingdom, Reading, Berkshire

Work Location:

Hybrid

What you will do

Commercial Quality Specialist & Qualified Person - UK
 

Location: Reading, Berkshire with hybrid working

Reports to: Commercial Quality Lead – UK & IE 

Staff role, no direct people management; lateral leadership across the network

The role:

• This position will act as Qualified Person for UK ensuring the batch certification of medicinal products manufactured and/or imported under the UK MIA in accordance with The Human Medicines Regulations 2012 and EU GMP, including Annex 16.and local procedures.

• The position will support regulatory submissions and changes to supply chain by preparing and approving QP declarations.

• Assess proposed changes to MA and provide impact assessment.

• Liaise with RA team to ensure prompt implementation of variations to MA.

• The position maintains understanding and awareness of current and emerging regulations applicable to the Qualified Person role, MIA License and GMP requirements and the impact to quality practices.

• This position is responsible for the oversight and execution of the Quality Management Systems and Compliance at Kenvue, identifying opportunities for continuously improvement, consistent with the company’s business objectives.

• The position implements departmental strategies and serves as a point of contact to the corresponding country operational teams on Quality related matters and will liaise with multiple Quality organizations to drive timely resolution of Quality related issues.

• The position optimizes quality systems and processes and ensures alignment with the worldwide business, applicable local regulations and the quality vision and/or Policy, and provides a measurable impact to quality, cost, and customer value.

• It also identifies significant business issues, prioritizes actions, leads and supports improvement opportunities and problem resolutions.

• The position plans, coordinates, and directs quality assurance programs designed to ensure effective and consistent processes with established standards by performing the following duties personally or with colleagues

Key Responsibilities 

Quality Management

• Batch certification of medicinal products manufactured or imported under the MIA

• Responsible for the maintenance and implementation the local Quality system

• Support the management, escalation, resolution and communication of quality issues

• Responsible for the qualification and approval of quality impacting suppliers

• Maintain and establish Quality Agreements with GxP suppliers as required by the local Quality Management System.

• Collaborate with other departments and functions to provide Quality related input to new projects and concepts

• Responsible for notification of product shortages to the Health Authority according to local regulation

Processes

• Maintain compliant and effective procedures to meet the business needs

• Assist in the local implementation of regional procedures

• Manage effectively all local procedures, work instructions and associated documentation

• Where requested provide input to draft global / regional procedures

• Provide Quality related input to marketing, sales and distribution activities/systems

Repack-Relabel, Co-packing and Warehousing

• Responsible for oversight of products storage and distribution according international and local regulations

• Responsible for defining, designing, and implementing quality requirements for repackaging and relabelling operations according to product owner specifications and local regulations

• Responsible for robust product impact evaluation and execution of product disposition

Quality Management Systems

• Responsible for ensuring the appropriate handling of quality related customer and consumer complaints including track and trend, and mitigation of related issues

• Responsible for ensuring that a change control system is implemented ensuring that any changes affecting the activities under Quality responsibility are appropriately controlled.

• Responsible for management of Quality systems, including NCs/CAPA process and systems, procedures, document management, change control, training management, Quality agreements for the activities that are under the scope of the position.

• Provide input into development projects, approval of artwork changes, management of quality issues and complaints, recalls, interface with official organisations, internal Quality groups, supplier sites and ensure internal quality standards are adhered to.

• Responsible for oversight and management of key Quality System elements, where requested by Cluster Head.

Compliance

• Act as a Quality representative for the Management Reviews.

• Provide support to the successful management of all Health Authority or external agency inspections as well as quality related internal audits (e.g. GRC, BRQC).

• Responsible for the proactive identification and mitigation of compliance risk through internal audits and other compliance programs.

• Support departmental goals and objectives, and business measurements for department.

• Responsible for evaluating the company’s quality and distribution process capabilities against company and industry standards and regulatory expectations.

• Act as Qualified Person named on the UK MIA license, including all required tasks of a Qualified Person

• Responsible for preparing and  hosting MHRA GMP inspections as Qualified Person

What we’re looking for:

• Registered ‘Qualified Person’ in UK (Pharmaceutical)

• Meet the MHRA eligibility criteria to be named on a UK Manufacturer’s Authorisation.

• Strong regulatory knowledge, licence maintenance and issue management

• Proven track record in Continuous Improvement and Quality Systems. 

• Previous experience interfacing with regulatory agencies, and a history of contributing to success in resolving complex regulatory compliance issues.

• Experience in KPI frameworks, QSMR, Change Control, Audits, and CAPA. 

• Knowledge of the manufacture and packaging processes of pharmaceutical products

• Experience with solid and liquid dosage products

• Analytical strength, prioritization, and structured problem-solving. 

• Effective communication and change management skills

• Organization and ability to work in complex and virtual environments

• Strong technical writing and data storytelling skills. 

• Fast risk based decision-making skills

Languages 

Fluent English; additional EMEA languages a plus. 

What’s in it for you

• Competitive Benefit Package        

• Paid Company Holidays, Paid Vacation, Volunteer Time & More!        

• Learning & Development Opportunities        

• Kenvuer Impact Networks        

       

Kenvue is proud to be an Equal Opportunity Employer. All qualified applicants will receive consideration for employment based on merit without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

If you are an individual with a disability, please check our Disability Assistance page for information on how to request an accommodation.