Sr. Manager, ESI Quality - PDMS-00000PDO
Description
POSITION SUMMARY:
This position will provide QA technical support for multiple External Manufacturers, primarily in China. Lead the development of corrective action plans and monitor implementation. Contribute to the overall development, implementation and execution of quality systems in support of the manufacturing , testing, packaging and labeling of clinical products for the R&D organization. Conduct investigations, perform customary audits, collect data, analyze trends, and prepare reports as required.
ESSENTIAL FUNCTIONS:
•Participate and Lead audits of R&D External Manufacturers (API and DP), packaging and labeling firms, distribution centers and contract testing laboratories
•Monitor trends, identify issues, recommend and implement appropriate actions.
•Provide cGMP compliance support to contract manufacturers by investigating and resolving quality issues.
•Coordinate and provide concurrences on deviations.
•Position requires occasional travel to External Manufacturer’s sites to provide cGMP assistance and quality oversight
•Assists with regulatory inspections and provides follow up on regulatory commitments.
•Develop, implement, and review of SOPs for interactions with External Manufacturers.
•Apply cGMP regulations and other FDA and international requirements to all aspects of the position.
•Coordinate change control documentation and approval process.
•Provide Quality oversight and participate on technology transfer teams.
•Provide Quality oversight on batch record review and batch release process.
•Interface collaboratively with other functions and stakeholders (PDMS, PQM, GPS, ESI, etc.)
•Ability to manage multiple and/or complex External Manufacturers.
•Demonstrated ability to operate with a minimum of supervision.
•Demonstrated ability to take ownership for and lead the resolution of complex Quality and Compliance issues with respect to External Manufacturing.
•Must be able to evaluate and interrelate with multiple quality systems associated with the different external manufacturers and determine suitability against J&J global standards.
•Escalates critical to quality issues in a timely manners and leads resolutions
•Routinely provides quality metrics for management review
•Review and provide input on global quality standards as required and interprets guidances for external manufacturers
ADDITIONAL RESPONSIBILITIES/DUTIES:
•Providing support to manufacturing / logistics organizations regarding aspects of GMP compliance associated with technology transfer and international manufacturing.
•Remaining current with FDA, EU and local regulations, guidelines, and quality practices associated with the pharmaceutical industry is required, including Good Tissue Regulations
•Computer literate well versed in Microsoft Office tools with the ability to communicate effectively electronically.
•Continued development of knowledge and expertise as needed in order to perform job duties.
•Strong communicator both written and verbal
Qualifications
Master’s Degree with a minimum of 8 years in a FDA regulated environment is required and in a pharmaceutical manufacturing or quality environment, including experience working in an R&D environment. Extensive knowledge of Quality Assurance, Quality Control and Compliance. Experience in API manufacturing is preferred.
Ability to provide cGMP compliance support to contract manufacturers by investigating and resolving quality issues is required. Basic Principles of Aseptic Processing is preferred. Proficiency in computer applications such as the MS Office suite is preferred. Position requires a minimum of 30% travel to external manufacturing sites.
Demonstrates mature skills in the following Global Leadership areas: Integrity and Credo Based Actions; Strategic Thinking; Big Picture Orientation with Attention to Detail; Intellectual Curiosity; Sense of Urgency; Results and Performance Driven; Collaboration and Teaming; Prudent Risk Taking; and Self Awareness and Adaptability.
Primary Location:Asia Pacific-China-Shanghai-Shanghai
Organization: Johnson & Johnson Medical China (7052)
Job Function: R&D
Description
POSITION SUMMARY:
This position will provide QA technical support for multiple External Manufacturers, primarily in China. Lead the development of corrective action plans and monitor implementation. Contribute to the overall development, implementation and execution of quality systems in support of the manufacturing , testing, packaging and labeling of clinical products for the R&D organization. Conduct investigations, perform customary audits, collect data, analyze trends, and prepare reports as required.
ESSENTIAL FUNCTIONS:
•Participate and Lead audits of R&D External Manufacturers (API and DP), packaging and labeling firms, distribution centers and contract testing laboratories
•Monitor trends, identify issues, recommend and implement appropriate actions.
•Provide cGMP compliance support to contract manufacturers by investigating and resolving quality issues.
•Coordinate and provide concurrences on deviations.
•Position requires occasional travel to External Manufacturer’s sites to provide cGMP assistance and quality oversight
•Assists with regulatory inspections and provides follow up on regulatory commitments.
•Develop, implement, and review of SOPs for interactions with External Manufacturers.
•Apply cGMP regulations and other FDA and international requirements to all aspects of the position.
•Coordinate change control documentation and approval process.
•Provide Quality oversight and participate on technology transfer teams.
•Provide Quality oversight on batch record review and batch release process.
•Interface collaboratively with other functions and stakeholders (PDMS, PQM, GPS, ESI, etc.)
•Ability to manage multiple and/or complex External Manufacturers.
•Demonstrated ability to operate with a minimum of supervision.
•Demonstrated ability to take ownership for and lead the resolution of complex Quality and Compliance issues with respect to External Manufacturing.
•Must be able to evaluate and interrelate with multiple quality systems associated with the different external manufacturers and determine suitability against J&J global standards.
•Escalates critical to quality issues in a timely manners and leads resolutions
•Routinely provides quality metrics for management review
•Review and provide input on global quality standards as required and interprets guidances for external manufacturers
ADDITIONAL RESPONSIBILITIES/DUTIES:
•Providing support to manufacturing / logistics organizations regarding aspects of GMP compliance associated with technology transfer and international manufacturing.
•Remaining current with FDA, EU and local regulations, guidelines, and quality practices associated with the pharmaceutical industry is required, including Good Tissue Regulations
•Computer literate well versed in Microsoft Office tools with the ability to communicate effectively electronically.
•Continued development of knowledge and expertise as needed in order to perform job duties.
•Strong communicator both written and verbal
Qualifications
Master’s Degree with a minimum of 8 years in a FDA regulated environment is required and in a pharmaceutical manufacturing or quality environment, including experience working in an R&D environment. Extensive knowledge of Quality Assurance, Quality Control and Compliance. Experience in API manufacturing is preferred.
Ability to provide cGMP compliance support to contract manufacturers by investigating and resolving quality issues is required. Basic Principles of Aseptic Processing is preferred. Proficiency in computer applications such as the MS Office suite is preferred. Position requires a minimum of 30% travel to external manufacturing sites.
Demonstrates mature skills in the following Global Leadership areas: Integrity and Credo Based Actions; Strategic Thinking; Big Picture Orientation with Attention to Detail; Intellectual Curiosity; Sense of Urgency; Results and Performance Driven; Collaboration and Teaming; Prudent Risk Taking; and Self Awareness and Adaptability.
Primary Location:Asia Pacific-China-Shanghai-Shanghai
Organization: Johnson & Johnson Medical China (7052)
Job Function: R&D