Quality Manager

Commercial Quality Manager 

Location: High Wycombe (Hybrid working)

Duration: 14 months / 20th December 2024

Hours: 40

Pay rate range: Negotiable

Imagine your next project working as a Quality Manager. Acting as the responsible person for import and responsible person on the UK Wholesale Dealer Authorisations and will provide support to the QA Cluster Head in the provision of the Quality Assurance service to all NEu Consumer Cluster business units, DCs and Customer Service locations.

roles and responsibilities

This position is responsible for the oversight and execution of the Quality Management Systems and Compliance at the Consumer UK and Ireland marketing company locations.

This will involve: 

• You will serve as a point of contact to the corresponding Business country operational leads on Quality related matters and will liaise with multiple Quality organisations to drive timely resolution of Quality related issues.

• You will define and implement departmental strategies and services as the business expert on Commercial quality systems and quality management.

• Optimise quality systems and processes and ensure 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.

• Identify opportunities for continuous improvement, consistent with Consumer Health Segment business objectives. 

• Identify significant business issues, prioritises actions, leads and supports improvement opportunities and problem solutions. 

• Maintain an understanding and awareness of current and emerging regulations and the impact to quality practices.

• Plan, 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.

Quality Management

• Support the UK and ROI 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 for Import on the UK wholesaler licence which includes:

  • confirm that products imported into GB from countries on the approved country for import list have been QP certified and batch released prior to receipt into GB

• Act as Responsible Person for the UK wholesaler licence which includes:

  • focusing on the management of authorised 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

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 the department.

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

how to succeed

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.

You will also bring:

• Undergraduate degree in Life Sciences, Engineering, Scientific or Business disciplines.

• To be able to meet requirements to act as MHRA Responsible Person for Import and GDP Responsible Person

• Fluent in English – written and oral

• Organised, and able to leadwork effectively with people within a complex social, cultural, and political environment.

• Excellent communication skills

• 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 a minimum of 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

A new global leader in consumer health is anticipated to arrive in 2023*: Kenvue

Kenvue’s purpose will be clear and inspiring: realise the extraordinary power of everyday care. 

Kenvue will have a bright future thanks to an iconic portfolio of consumer brands that have delivered care, comfort and confidence for generations. With a passion for uncovering real solutions and a fierce dedication to helping others, Kenvue will put the power of care into the hands of people across the world—every generation, every season, every morning

We believe that when people can count on care every day, it not only makes them well; it makes them whole—and empowers them to engage more fully with the people, experiences and world around them.

We can’t wait to share Kenvue‘s new view of care with the world.

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. PAYE & Umbrella options are available. 

Diversity, Equity & Inclusion

For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at KENVUE and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.

We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences. That is why we are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each one of our people feels that they belong and can reach their potential. No matter who they are. Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”.