Quality Project Lead/Senior Quality Manager - Leeds

UKCA (United Kingdom Conformity Assessment) Localisation Quality Project Lead

Duration 12 Months

Location – Leeds, 5 days on-site required

The Company:

Johnson & Johnson is the world's most comprehensive and broadly-based healthcare Company, touching the lives of nearly a billion people every day. Our Family of Companies throughout the world compete in consumer, pharmaceutical and medical devices & diagnostics markets and have the skills and resources to tackle the world's most pressing health issues.

Position Summary

Accountable for quality deliverables for UKCA localisation project at Beeston Facility Lead.  Localisation is a new process in the Beeston (Leeds) Facility to add supplemental labels onto the DePuy Synthes portfolio designated to be placed on the UK market.  This person will be a strong leader, skilled in delivering results on all quality deliverable such as Validation, Business software, equipment etc.

Responsibilities

• Accountable for overall project management activities within the Quality Workstream
• Ownership of Change Control Activities 
• Ownership of standard operating procedures (SOP) update execution strategy
• Development of new procedures, specifications and quality standards
• Ownership of process validation
• Authoring documents e.g. Validation Plan, Performance Qualification
• Reviewing/approval of documents
• Ownership of overall delivery of ASAPI business software system, working in conjunction with J&J partners in LATAM
• Ownership of Test Method Validation Activities

Requirements

• 5+ Years’ experience in QA processes (desirable) (described above)
• Understanding of UKCA requirements for placing product onto the UK market 
• Project Management experience
• Basic knowledge of Regulatory Affairs 
• Excellent team working skills
• Pro-active approach to achieving success
• Drive to shape an inclusive and equitable working culture
• Eligible to work within the UK on a permanent basis

These can have been proven through education, project work, work experience or life experience.

In Return:

In return for this role you will receive a very competitive hourly rate. A minimum 12 month contract & an opportunity to work with a Global Leader within the Pharmaceutical sector, Johnson & Johnson. 

Things to remember before applying for this role:

• This role is INSIDE IR35. The pay rate for this role will depend on how you are paid (PAYE or Umbrella options).
• We are looking to process the first round of applications within the next 2 working days.
• We do not accept applications via email.

Thank you very much and we look forward to receiving your application. 

If you would like some additional information about the role please contact: Tabitha.crabtree@randstadsourceright.co.uk

Diversity, Equity & Inclusion:

For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson 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”.