Junior ‘Qualified Person’ & Commercial Quality Specialist

Junior ‘Qualified Person’ & Commercial Quality Specialist

Was wir tun

Bei Kenvue erkennen wir die außergewöhnliche Kraft der täglichen Pflege. Aufbauend auf über einem Jahrhundert Tradition und verwurzelt in der Wissenschaft, sind wir das Haus der ikonischen Marken - darunter NEUTROGENA®, AVEENO®, TYLENOL,® LISTERINE®, JOHNSON'S® und BAND-AID®, die Sie bereits kennen und lieben. Wissenschaft ist unsere Leidenschaft; Fürsorge ist unser Talent.

Wer wir sind

Unser globales Team besteht aus ~ 22.000 brillanten Mitarbeitern mit einer Arbeitsplatzkultur, in der jede Stimme zählt und jeder Beitrag geschätzt wird. Wir sind leidenschaftlich an Erkenntnissen interessiert, Innovation und dem Engagement, unseren Kunden die besten Produkte zu liefern. Mit Fachwissen und Einfühlungsvermögen bedeutet ein Kenvuer zu sein, die Macht zu haben, jeden Tag Millionen von Menschen zu beeinflussen. Wir stellen den Menschen an die erste Stelle, kümmern uns leidenschaftlich, gewinnen Vertrauen in der Wissenschaft und lösen Lösungen mit Mut – und haben brillante Möglichkeiten, die auf Sie warten! Gestalten Sie mit uns unsere Zukunft – und Ihre. Für weitere Informationen, klicken Sie auf hier.

Rollenberichte an:

Commercial Quality Manager - Iberia

Standort:

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

Arbeitsort:

Hybrid

Was Sie tun werden

This role is able to offer a positive work life balance and flexible/hybrid working. It may also be suitable for a newly certified ‘QP’ .

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. This position will also act as Responsible Person back-up to the current Responsible Person for the UK market.

• 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. It also supports departmental goals and objectives, and business measurements for department.

Key Responsibilities 

Quality Management

• Batch certification of medicinal products manufactured and/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, including maintaining the required associated documentation such as Quality Agreements

• 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.

• Oversight of products supply chain

Processes

• Maintain compliant and effective procedures to meet the business needs

• Assist in the local implementation of regional procedures

• Develop, update, review and approve 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

• Approve Finished Good Specifications

• Preparing data collection, reviewing and approving PQRs.

Repack-Relabel, Co-packing and Warehousing

• Oversight of products storage and distribution according international and local regulations

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

• Evaluating product impact and execution of product disposition when applicable

Quality Management Systems

• Responsible for management of Quality systems, including Nonconformances and CAPA process and systems, Procedural documents, document management, Change Control, Training management, Supplier and Customer management and qualification.

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

• Provide input into development projects, approval of artwork changes, management of quality issues and complaints, product 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

• Preparing and attending Quality 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.

• 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

• Act as backup Responsible Person named on the WDA UK License

• Responsible for preparing and hosting MHRA inspections

What we’re looking for:

Qualifications 

• Registered Qualified Person in UK

• Registered Responsible Person in UK

• 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. 

Competencies 

• Knowledge of the manufacture and packaging processes of pharmaceutical products

• Experience with solid and liquid dosage products

• Experience with matrix organisation Strategic Quality Management with business outcome focus. 

• 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.

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