MD Global Surgery Companies of Johnson & Johnson is seeking a Senior Director, Sterility Assurance to be located in either Irvine, CA or Raritan, NJ.
The Global Surgery Group is comprised of the following businesses within Johnson & Johnson: Ethicon Surgical Care, Ethicon Energy, Ethicon Biosurgery, Acclarent, Biosense Webster, Mentor and Sterilmed. With annual sales of $11 billion, the Global Surgery Group is the world’s largest, most innovative surgical company. The strength of the Global Surgery Group is illustrated by the fact that more than 80% of our sales come from businesses with #1 or #2 global market share positions. We serve customers around the world, with about 60% of our sales generated outside the U.S., including a fast-growing presence in emerging markets. The Global Surgery Group is committed to innovation, with about 30% of our sales coming from products introduced in the past five years.
The Senior Director, Sterility Assurance will:
· Be accountable to all MD Global Surgery operating companies, design centers and manufacturing sites.
· He/she will serve as the global technical leader in the areas of sterilization, aseptic processing and microbiology with responsibility for all Global Surgery locations worldwide.
· This individual will be responsible for defining company policy and developing company strategies with respect to cleanliness, sterilization, clean rooms, pure water systems and related areas.
· The Senior Director, Sterility Assurance will work with the Make organization to establish long-range sterilization strategies for Global Surgery products.
· He/she will have managerial responsibility for Global Surgery Sterility Assurance functions. This individual will need to actively network with the internal and external scientific, technical and regulatory community to maintain state of the art knowledge.
The Senior Director, Sterility Assurance will
· Support new product development, collaborating with Product Development and suppliers to provide design inputs as well as to validate sterile and microbiologically controlled products.
· This individual’s duty will also include working with Supply Chain to establish, validate and maintain clean manufacturing environments, processes and utilities.
· He/she will be responsible for compliance to applicable Quality Regulations, ISO and AAMI standards, and other regional standards.
· The Senior Director, Sterility Assurance will interact with external regulators and various levels of company management, working across many functional areas.
· He/she will influence the company’s strategic and tactical directions and financial results globally through the application of technical leadership, knowledge and expertise.
· The Senior Director, Sterility Assurance will assure that Global Surgery programs are aligned with the overall J&J Sterility Assurance programs.
· Technical areas overseen include:
o Sterilization validation (for EO, gamma, electron beam, moist heat, and dry heat processes),
o Microbiological testing to support the validation and maintenance of the sterilization processes and product label claims (e.g., bioburden, tests of sterility, BET),
o Environmental control and monitoring,
o Reusable device reprocessing validation,
o Water systems validation,
o Sterility assurance support to new product development and launch,
o 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 Senior Director, Sterility Assurance will provide input in the design of manufacturing processes, controlled environments and packaging from a microbiological standpoint.
· He/she will also provide input for the design of DI water systems and the design of controlled environments and cleanliness control strategies.
· Other duties and responsibilities as assigned.
· 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.
· A Demonstrated competency in multiple industrial terminal sterilization methods (e.g., EO, gamma, electron beam, moist heat, dry heat) is required.
· Understanding of the sterilization process microbiological lethality as it relates to both product design and sterilization processing is required.
· Competency in additional technical areas such as reprocessing and microbiology laboratory operations experience is desired.
· Demonstrated capability to lead and train a diverse, multinational community of practice with multiple stakeholders, working in a supervisory, coaching, mentoring and/or influencing capacity is required.
· Experience in interacting with Regulatory Authorities is required.
· Experience with conducting technical assessments of in-house and contract sterilization processes or contract microbiological laboratories is preferred.
· A proven track record on trouble shooting microbiological and/or sterilization process non-conformances and out of specification test results, and providing resolution to issues via robust CAPA is required.
· A high level knowledge of standards including AAMI and ISO is required
· The capability of representing the corporation at industry and standards associations, influencing regulations and standards is desired.
· Excellent oral and written skills and able to communicate both up and down the business ladder within franchise or technical competency area is required.
· A demonstrated ability to work in a collaborative/teamwork environment is required.
· Independent organizational and time management skills is required.
· The ability to be a team player with a customer focus is required.
Required Education and Experience:
· An undergraduate (BS) degree with Microbiology, Biology, Engineering or related discipline is required; an advanced degree (MS or PhD) is preferred.
· A minimum of 15 years of experience in a medical device or pharmaceutical. (combination) industry with a GMP and/or ISO regulated environment is required.
· A minimum of 10 years of direct people management experience is required.
· Competency in using computer software such as Excel, Word and PowerPoint, and analytical software.
· This position can be located in either Raritan, NJ or Irvine, CA and will require travel.