Microbiological Quality & Sterility Assurance Manager
Join to apply for the Microbiological Quality & Sterility Assurance Manager role at Johnson & Johnson MedTech
Microbiological Quality & Sterility Assurance Manager
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Join to apply for the Microbiological Quality & Sterility Assurance Manager role at Johnson & Johnson MedTech
At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.Learn more at https://www.jnj.com
Job Function
Quality
Job Sub Function
R&D/Scientific Quality
Job Category
People Leader
All Job Posting Locations:
Blackpool, Lancashire, United Kingdom
Job Description
At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.
Learn more at https://www.jnj.com/
J&J MedTech is recruiting for a Microbiological Quality & Sterility Assurance Manager reporting to the Sr Mgr Microbiological Quality & Sterility Assurance and to be based in Blackpool (UK).
Description
The Microbiological Quality & Sterility Assurance Manager position is responsible for end-to-end implementation of contamination control and sterility assurance policies and strategies for the DePuy Synthes Blackpool manufacturing site and will assure that Business Unit/Franchise Global Orthopedics programs are aligned with the overall J&J Sterility Assurance programs.
The Microbiological Quality & Sterility Assurance Manager will serve as the Blackpool DePuy Synthes technical leader in the areas of aseptic processing, contamination control, sterilization, reprocessing and microbiology. They manage teams to support product development and product manufacturing activities. They set the strategic and tactical direction of the team through the application of technical knowledge and expertise in contamination control, aseptic processing, sterilization processing and industrial microbiology. This position is responsible for compliance to applicable Quality Regulations and standards.
This individual will be responsible for activities such as, but not limited to, the following:
* R&D
o provide technical leadership on contamination control and sterility assurance for new product development
o ensure contamination control and sterility assurance support for product development teams, prioritizing projects with product development and ensuring support during the product development cycle.
o apply best practices in the selection, investigation and validation of aseptic manufacturing and sterilization methodologies in accordance with applicable regulations and standards
o ensure design changes meet contamination control and sterility assurance requirements
o support due diligence on contamination control and sterility assurance for acquisitions and new product licensing
o provide support in the development of design history files and regulatory submissions to ensure compliance to applicable regulations and standards internationally
o drive innovation to provide novel methodologies, processes or strategies for contamination control and sterilization.
o provide expertise in the development of processing instructions for use and associated validation for the cleaning, disinfection and sterilization of non-sterile or reusable devices
* Plan
o participate in the development and selection of new Business Unit/Franchise manufacturing operations (to include manufacturing sites and facility investments, contract sterilization & laboratories, and third-party manufacturers)
o Support business acquisitions and divestures as required.
* Source
o 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
o provide technical SME support for procurement activities that relate to sterile, non- sterile or microbiologically controlled products that are externally manufactured
o provide input in the design of new manufacturing processes, controlled environments and packaging from a microbiological, terminal sterilization and reprocessing standpoint
o 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
o provide technical leadership on contamination control and sterility assurance at Business Unit/Franchise manufacturing facilities
o maintain knowledge of best practices, standards and guidance in sterilization, processing, aseptic technique and environmental monitoring. Ensure Business Unit/Franchise policies and procedures are maintained to ensure compliance.
o 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
o ensure process changes meet contamination control and sterility assurance requirements
o manages and dispositions microbiological or contamination control CAPAs and non- conformances, including root cause identification and corrective action implantation within agreed timelines
o supports technical assessments of third party manufacturers, sterilization contractors, external laboratories and other applicable suppliers.
o provide leadership and support during facility audits
o 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
o Support wider manufacturing engagement with external manufacturers to ensure J&J best practices are being adhered to
* Deliver
o customer engagement and support, monitoring trends in Customer needs with feedback to Management
* External Influencing
o identifies external opportunities to influence best practices in sterility assurance and contamination control by interacting with regulators, standard/guideline organizations, research and academic institutions.
o Engage with external industry experts to support the development of new and revised regulatory standards
* Internal Influencing
o 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.
o Actively participate and assume leadership position on the J&J Sterility Assurance Councils
o 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
o Provide technical leadership in the establishment of a robust supply chain for sterilization for DePuy Synthes and wider J&J franchises
o Identification and exploration of novel sterilisation modalities, evaluating their suitability and supporting their deployment within DePuy Synthes and wider J&J franchises
o 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.
Seniority level
* Seniority level
Not Applicable
Employment type
* Employment type
Full-time
Job function
* Job function
Quality Assurance
* Industries
Hospitals and Health Care
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