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在 Kenvue，我們意識到日常護理的非凡力量。我們以一個多世紀的傳統為基礎，植根於科學，是標誌性品牌的品牌 - 包括您已經熟悉和喜愛的 NEUTRGENA®、AVEENO、TYLENOL®®、LISTERINE®、JOHNSON'S® 和 BAND-AID®。科學是我們的熱情所在;關心就是我們的才能。
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我們的全球團隊由 ~ 22,000 名才華橫溢的員工組成，他們的職場文化中，每個聲音都很重要，每一個貢獻都受到讚賞。 我們熱衷於洞察， 創新並致力於為我們的客戶提供最好的產品。憑藉專業知識和同理心，成為 Kenvuer 意味著每天有能力影響數百萬人。我們以人為本，熱切關懷，以科學贏得信任，以勇氣解決——有絕佳的機會等著您！加入我們，塑造我們和您的未來。有關更多資訊，請按兩下 here.
Role reports to：
Commercial Quality Lead, Ireland位置：
Europe/Middle East/Africa, United Kingdom, Reading, Berkshire工作地點：
混合你會做什麼
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.
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