Manager, Microbiological Quality & Sterility Assurance

at J&J Family of Companies in Dover, Delaware, United States

Manager, Microbiological Quality & Sterility Assurance ( MQSA ) – 2406175666W

Description

DePuy Synthes is recruiting for a Manager, Microbiological Quality & Sterility Assurance ( MQSA ).

DePuy Synthes , part of the Johnson & Johnson Medical Devices Companies, provides one of the most comprehensive orthopedics portfolios in the world. DePuy Synthes solutions, in specialties including joint reconstruction, trauma, craniomaxillofacial, spinal surgery and sports medicine, are designed to advance patient care while delivering clinical and economic value to health care systems worldwide.

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Reporting to the Senior MQSA Manager, the Manager, MQSA is responsible for supporting the end-to-end contamination control and sterility assurance practices for the development of new products and/or sustainment of commercial products within Global Orthopedics. The Manager, MQSA will directly support product manufacturing at the J&J MedTech manufacturing facility in Costa Rica.

The Manager, MQSA technical areas overseen include: cleaning and disinfection requirements, sterilization validation (for EO, gamma, electron beam, 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, 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 Manager, MQSA will also be responsible for development, implementation, and maintenance of quality system procedures used to support the above technical areas for products manufactured in Costa Rica and expansion of on-site capabilities. The role will be initially based from an existing J&J-approved facility. The incumbent must be eligible for interim travel to Costa Rica (passport, visas, etc) and must be willing to relocate to the area at a later date for local support of medical device manufacturing.

Key Responsibilities:

Under general direction and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:

• R&D -

o provide technical support in the selection, investigation and validation of aseptic manufacturing and sterilization methodologies

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

• Plan -

o provide support in the development and selection of new manufacturing operations (to include manufacturing sites and facility investments, contract sterilization & laboratories, and third-party manufacturers)

• Source -

o provide support 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 critical water and air systems and the design of controlled environments and cleanliness control strategies

o Provide technical SME support for sterility assurance and contamination control in supplier audits.

• Make -

o ensure the implementation of contamination control and sterility assurance policies at defined manufacturing facilities

o ensure process changes meet contamination control and sterility assurance requirements

o lead the investigation, gap analysis and develop the corrective action plan for 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 technical support during onsite inspections

o work with internal and external laboratories to support sterility assurance testing requirements. Assure implementation of laboratory testing requirements for cleanliness and sterility assurance.

o work 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

• Deliver -

o Support the ongoing initiatives regarding the validation and improvement of primary non-sterile and sterile packaging systems that meet the needs of distribution system and delivery of sterile or microbiologically controlled product to the patient and/or consumer

• External Influencing -

o monitors best practices in sterility assurance and contamination control by interacting with JJSA leadership.

• 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 participate on the J&J Sterility Assurance Councils as assigned by management.

• Responsible for communicating business related issues or opportunities to next management level.

• For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable.

• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.

• Performs other duties assigned as needed.

Qualifications

Education:

+ An undergraduate (BS) degree with Microbiology, Biology, Engineering or related discipline is required; an advanced degree, such as MS or PhD is preferred.

Experience and Skills:

Required:

+ 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.

+ 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

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

+ Demonstrate competency in terminal sterilization, reprocessing, and/or microbiological contamination controls.

+ Demonstrated competency in multiple healthcare and industrial terminal sterilization methods (e.g., gas, radiation, heat) and relevant standards for terminal sterilization processes.

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

Preferred:

• Previous experience establishing quality system requirements for industrial microbiology and sterility assurance.

• Demonstrated capability to lead and train support personnel.

• English / Spanish fluency is preferred due to geographic location of this role.

Other:

+ **The incumbent must be eligible for interim travel to Costa Rica (passport, visas, etc) and must be willing to relocate to the area at a later date for local