Commercial Quality Manager, UK RP and RPi
Location: London, Greater London GB
Job Number: 17568
External Description:
Commercial Quality Manager, UK RP and RPi (maternity cover)
Location: High Wycombe, UK -
Duration: 14 months
Hours: 22.5 hours per week / 3.5 days per week
This position is responsible for the oversight and execution of the Quality Management Systems and Compliance at the Consumer UK marketing company location.
The position serves as a point of contact to the corresponding Business country operational leads on Quality related matters and will liaise with multiple Quality organizations to drive timely resolution of Quality related issues.
The position defines and implements departmental strategies and services as the business expert on Commercial quality systems and quality management.
The position optimizes quality systems and processes and ensures alignment with the worldwide business, applicable local regulations & Kenvue standards, the quality vision and/or Policy, and provides a measurable impact to quality, cost, and customer value.
The position identifies opportunities for continuously improvement, consistent with Consumer Health Segment business objectives.
The position identifies significant business issues, prioritizes actions, leads and supports improvement opportunities and problem solutions.
The position maintains understanding and awareness of current and emerging regulations and the impact to quality practices.
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.
This position will act as the Responsible Person and Responsible Person for importation (RPi) on the UK Wholesale Dealer Authorisation and will provide support to the QA Cluster Head in the provision of the Quality Assurance service to the UK business and to all other NEu Consumer Cluster business units, DCs and Customer Service locations, when requested.
roles and responsibilities
Quality Management
- Support the UK business units in terms of quality management and the resolution and communication of quality issues
- Responsible for establishing Quality Agreements with quality impacting business suppliers.
- Responsible for the qualification and approval of quality impacting business suppliers managed by the marketing companies
- Responsible for the maintenance and implementation the local Quality system
- Collaborate with other departments and functions to provide QA input to new projects and concepts
Processes
- Maintain compliant and effective procedures to meet the business needs
- Assist in the implementation of regional procedures
- Manage effectively all local procedures, work instructions and associated documentation
- Where requested provide input to draft global / regional procedures
- Provide QA input to sales and distribution activities/systems
Repack-Relabel, Co-packing and Warehousing
- Responsible for oversight of Consumer 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
- Responsible for robust product impact evaluation and execution of product disposition.
- Act as Responsible Person and RPi for the UK wholesaler dealer authorization which includes:
- focusing on the management of authorized activities and the accuracy and quality of records
- ensuring that initial and continuous training programmes are implemented and maintained
- coordinating and promptly performing any recall operations for medicinal products
- ensuring that relevant customer and consumer complaints are dealt with efficiently
- ensuring that suppliers and customers are approved
- approving any subcontracted activities that may impact GDP
- ensuring that self-inspections are performed at appropriate intervals following a prearranged programme and necessary corrective measures are put in place
- keeping appropriate records of any delegated duties
- deciding on the final disposition of returned, rejected, recalled or falsified products
- approving any returns to saleable stock
- ensuring that any additional requirements imposed on certain products by national law are adhered to
- maintain competence in GDP through regular trainings (internal/external)
- ensure that regular GDP trainings are provided to appropriate roles
- Act as Responsible Person for Importation on the UK wholesaler dealer authorization
- implement a system to confirm that medicinal products have been imported from countries on an approved list and that the required QP certification has taken place.
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 NEu Management Reviews.
- Provide support to the successful management of all Health Authority or external agency inspections as well as quality related inspections.
- Responsible for the proactive identification and mitigation of compliance risk through internal audits and other compliance programs.
- Accountable and responsible for timely and accurate metrics and reports per Kenvue policies.
- 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.
how to succeed
- To be able to meet requirements to act as MHRA GDP Responsible Person
- Fluent in English – written and oral
- Undergraduate degree in Life Sciences, Engineering, Scientific or Business disciplines.
- This role requires a diverse business background, preferably with direct experience in Consumer Health OTC/Mass and/or Pharma sectors, with specific quality, regulatory and regulatory compliance competencies in the areas of customer service, distribution, and commercial customer interface. Experience in positions of increasing responsibility, with broadly based quality management experience. Experience with the global demands of the role, specifically: healthcare regulatory requirements.
Proven success in:
- Quality and Compliance management, with customer and business focus.
- Quality improvement programs, risk reduction projects, added value solutions.
- Compliance experience, QMS experience.
- Change management and project management experience.
- Strong presentation skills.
- Issue remediation experience.
- Collaborative approach.
- Managing complexity.
- Analytical skills - ability to zoom-in/zoom-out for tactical, high-level and detailed views.
- Previous experience interfacing with regulatory agencies and a history of success and credibility resolving complex regulatory compliance issues.
benefits
This role offers a very competitive hourly rate. This contract will run for 14 months
you are welcome here
Kenvue is working to create an inclusive environment where diverse backgrounds, perspectives, and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are.
About Kenvue
At Kenvue, we realise 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. Our global team is made by 22,000 diverse and brilliant people, passionate about insights, innovation and committed to deliver the best products to our customers. With expertise and empathy, being a Kenvuer means to have the power to impact life of 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
application process
We are looking to process the first round of applications within the next 2 working days.
We do not accept applications via email. The pay rate for this role will depend on how you are paid.
Diversity, Equity & Inclusion
Kenvue is proud to be an Equal Opportunity Employer. All qualified applicants will receive
consideration for employment based on business needs, job requirements, and individual qualifications, without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, protected veteran status, or any other legally protected characteristic, and will not be discriminated against on the basis of disability.
Job Number: KVUE2JP00000429
Community / Marketing Title: Commercial Quality Manager, UK RP and RPi
Location_formattedLocationLong: London, Greater London GB