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Job Description:

• supports technical assessments of third party manufacturers, sterilization contractors, external laboratories and other applicable suppliers.
• provide leadership and support during facility audits
• maintain close involvement/alignment with the local Sterilization Execution organization to support the release of sterile product, and addressing any issues that might arise during the execution of the sterilization 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

• External Influencing
  • identifies external opportunities to influence best practices in sterility assurance and contamination control by interacting with regulators, standard/guideline organizations, research and academic institutions.
  • Engage with external industry experts to support the development of new and revised regulatory standards

• Internal Influencing
  • interacts with business leaders to ensure objectives and project prioritization meet business needs. Interacts with their peers in sterility assurance to utilize resources and ensure best practices across facilities.
  • Actively participate and assume leadership position on the J& J Sterility Assurance Councils
  • Provide training and mentorship to J& J MQSA personnel across all franchises in sterilization best practices within Gas, Heat and novel modalities

• Sterilization Supply Chain Sustainability
  • Provide technical leadership in the establishment of a robust supply chain for sterilization for DePuy Synthes and wider J& J franchises
  • Identification and exploration of novel sterilisation modalities, evaluating their suitability and supporting their deployment within DePuy Synthes and wider J& J franchises
  • Provide regional support to JJMQSA Tiger Teams in the realization of their sterilization objectives.

The technical areas overseen by the Microbiological Quality & Sterility Assurance Manager include: aseptic processing, cleaning and disinfection requirements, sterilization validation (for EO, gamma, electron beam, x-ray, moist heat, and dry heat processes), reprocessing, microbiological testing to support the validation and maintenance of the sterilization 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.

qualified candidates will have experience in microbiology, sterilization validation (terminal, aseptic, and/or reprocessing) and environmental controls for a medical device or pharmaceutical manufacturing facility 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 sterilization 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 organizational and time management skills is required

Education and Experience:

• an undergraduate (BS) degree with Microbiology, Biology, Engineering or related discipline is required; an advanced degree is desirable.
• a minimum of 8 years of experience in a medical device or pharmaceutical (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.