Quality Assurance Manager

Microbiological Quality & Sterility Assurance Manager 

Location: Leeds, UK 

Duration: 12 months 

Hours: 37

This role falls outside IR35

Imagine your next project working with DePuy Synthes where you will be responsible for end-to-end implementation of contamination control and sterility assurance policies and strategies for the DePuy Synthes Leeds manufacturing site and will assure that Business Unit/Franchise Global Orthopaedics programs are aligned with the overall J&J Sterility Assurance programs.

roles and responsibilities

The Microbiological Quality & Sterility Assurance Manager will serve as the Leeds DePuy Synthes technical leader in the areas of contamination control, sterilisation, reprocessing and microbiology. They manage a team to support product development and product manufacturing activities. They ensure the execution of the strategic and tactical direction by the team through the application of technical knowledge and expertise in contamination control, sterilisation processing and industrial microbiology. This position is responsible for compliance to applicable Quality Regulations and standards.

This also includes:

• R&D 

  • provide technical leadership on contamination control and sterility assurance for new product development

  • ensure contamination control and sterility assurance support for product development teams, prioritising projects with product development and ensuring support during the product development cycle.

  • apply best practices in the selection, investigation and validation of sterilisation methodologies in accordance with applicable regulations and standards

  • ensure design changes meet contamination control and sterility assurance requirements

  • support due diligence on contamination control and sterility assurance for acquisitions and new product licensing

  • provide support in the development of design history files and regulatory submissions to ensure compliance to applicable regulations and standards internationally

  • provide expertise in the development of processing instructions for use and associated validation for the cleaning, disinfection and sterilisation of non-sterile or reusable devices

• Plan 

  • participate in the development and selection of new Business Unit/Franchise manufacturing operations (to include manufacturing sites and facility investments, contract sterilisation & laboratories, and third-party manufacturers)

  • Support business and product line expansions and acquisitions as required. 

• Source 

  • participate in Business Unit/Franchise due diligence for sterile, non-sterile or microbiologically controlled manufactured products, and provide technical SME support for integration into J&J

  • provide technical SME support for procurement activities that relate to sterile, non- sterile or microbiologically controlled products that are externally manufactured

  • provide input in the design of new manufacturing processes, controlled environments and packaging from a microbiological, terminal sterilisation and reprocessing standpoint

  • provide input for the design of Business Unit/Franchise critical water and air systems and the design of controlled environments and cleanliness control strategies

• Make 

  • provide technical leadership on contamination control and sterility assurance at Business Unit/Franchise manufacturing facilities

  • maintain knowledge of best practices, standards and guidance in sterilisation, processing and environmental monitoring. Ensure Business Unit/Franchise policies and procedures are maintained to ensure compliance.

  • develop and maintain Business Unit/Franchise or facility-specific guidelines and standards for contamination control and sterility assurance in accordance with franchise, corporate and applicable international standards

  • ensure process changes meet contamination control and sterility assurance requirements

  • manages and dispositions microbiological or contamination control CAPAs and non- conformances, including root cause identification and corrective action implantation within agreed timelines

  • supports technical assessments of third party manufacturers, sterilisation contractors, external laboratories and other applicable suppliers.

  • provide leadership and support during facility audits

  • maintain close involvement/alignment with the local Sterilisation Execution organisation to support the release of sterile product, and addressing any issues that might arise during the execution of the sterilisation processes

  • Support wider manufacturing engagement with external manufacturers to ensure J&J best practices are being adhered to

• Deliver 

  • customer engagement and support, monitoring trends in Customer needs with feedback to Management

• Internal Influencing 

  • interacts with business leaders to ensure objectives and project prioritisation meet business needs. Interacts with their peers in sterility assurance to utilise resources and ensure best practices across facilities.

  • Provide training and mentorship to J&J MQSA personnel on the Leeds site in sterilisation best practices within irradiation and Gas modalities 

• Sterilisation Supply Chain Sustainability

  • Provide technical leadership in the establishment of a robust supply chain for sterilisation for DePuy Synthes and wider J&J franchises

  • Provide regional support to Sterility Assurance regarding their sterilisation objectives. 

• The technical areas overseen by the Microbiological Quality & Sterility Assurance Manager include: device cleaning and disinfection requirements, sterilisation validation (for Ethylene Oxide and Irradiation processes), reprocessing, microbiological testing to support the validation and maintenance of the sterilisation processes and product label claims (e.g., bioburden, tests of sterility, endotoxin monitoring), environmental control and monitoring, water and air systems validation, sterility assurance support to new product development and launch, compliance to applicable regulations and standards in the subject areas of sterility assurance and laboratories. Inspection and submission support and Health based risk assessment.

• The Microbiological Quality & Sterility Assurance Manager will also be responsible to ensure the development of their team to include career development, work-life balance, succession planning etc.

how to succeed

• An undergraduate (BS) degree with Microbiology, Biology, Engineering or related discipline is required; an advanced degree is desirable.

• A minimum of 5 years of experience in microbiology, sterilisation validation (terminal, and/or reprocessing) and environmental controls for a medical device or pharmaceutical manufacturing facility (combination) industry with a GMP and/or ISO regulated environment is required.

• Proven track record in team management

• Competent in using computer software such as Excel, Word and PowerPoint, and analytical software

• Demonstrated capability to lead and train a large and diverse, multinational community with multiple stakeholders, working in a supervisory, coaching, mentoring and/or influencing capacity

• Must have a strong understanding of product design, quality and manufacturing processes.

• Proven track record on troubleshooting process non-conformances and out of specification test results, and providing resolution to issues by a robust CAPA process

• Experience in interacting with Regulatory Authorities is preferred

• Experience with conducting technical assessments of in-house and external manufacturing and terminal sterilisation is preferred

• Strong knowledge of standards including EU, USA and ISO is required

• Strong teamwork and communication skills to work effectively on cross-functional project teams, interacting with a diversity of disciplines such as R & D, Packaging Engineering, Quality Engineering, Regulatory Affairs, Marketing, etc.

• Independent organisational and time management skills is required

Benefits

This role offers a very competitive hourly rate. This contract will run for a minimum of 12 months. 

you are welcome here

Johnson & Johnson 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 DePuy Synthes

DePuy Synthes is the orthopaedic and neurological businesses of Johnson & Johnson - the world's most comprehensive and broadly-based healthcare company. At DePuy Synthes we specialise in our innovations in healthcare products, services and programs that make a real difference to millions of people across the world. We specialise in joint reconstruction, trauma, extremities, craniomaxillofacial, spinal surgery and sports medicine, and also the VELYS™ Digital Surgery portfolio. Contribute to the next healthcare breakthrough with your next project at DePuy Synthes. 

https://www.jnjmedtech.com/en-US/companies/depuy-synthes

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, Limited & Umbrella options are available. 

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”.