Janssen Supply Group, LLC is recruiting for a Manager ESIQ Supplier Quality in located in Athens, GA

At Johnson Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions 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/.

External Quality team member having the Quality oversight responsibility of assigned Suppliers as part of Janssen Supply Chain Portfolio, ensuring quality standards are achieved and maintained at suppliers through management, and monitoring. This role has both site and global interactions, as well as, use of all Global Quality Systems including (NC/CAPA, Audit, Change Control, Escalation, etc.) Acting as the Single Point of Contact (SPOC) for Supplier Quality at the Athens, GA site.

Key Responsibilities:Planning, execution, and documentation of the qualification and monitoring for suppliers who are sourcing APIs, API materials or DP materials such as excipients, raw or packaging materials, to the Janssen Supply Chain for the manufacture of Intermediates, APIs, or drug products respectivelySurveillance on the quality and compliance status for all suppliers under the Account OwnershipPerforming audits, technical visits, and proactive engagements at suppliers and external manufacturersManagement of Change related to supplier and/or external manufacturers (change assessor, action executioner, change approvers)Assessment of deviations, corrective and preventative actions (CAPAs), and complaints concerning suppliers and external manufacturersProvision of all information needed for the release/reject of suppliers in SAP (SAP master data)Establishment of JJ Quality requirements and Quality agreements and periodic review of Quality AgreementsQualification of suppliers for new product introductionsPeriodic performance measurement for suppliers; including face to face meetingsProvide support to JSC local Site during Customer and HA inspections as neededEnsure the supplier Specification agreement and approval managementThey consistently work with external business partners for the purpose of driving the development of core process reliability at external sites.Act as SPOC (single point of contact) for local JSC site, representing EQ-SQ in Site related matters.Involvement in Change Management, escalations, compliance issues, recalls, field action that are related to suppliers and/or to the local JSC siteBuild an accurate connection with the local JSC site establishing periodical meeting with the site Quality Organization to get and provide updating/alignment about the RR and any shared activities/objectivesConnect periodically (weekly is recommended) with local JSC site, local planning, Global procurement (Quartet approach) to discuss and review of the Supplier Quality ongoing performanceEnsure to reach out all appropriate members of EQ that could be requested by the site or any stakeholder (e.g. HA inspection, Escalation, significant investigation)During the HA inspections: Support the local site (in presence), being the reference for any SQ related activities as:

Janssen Supply Group, LLC is recruiting for a Manager ESIQ Supplier Quality in located in Athens, GA

At Johnson Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions 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/.

External Quality team member having the Quality oversight responsibility of assigned Suppliers as part of Janssen Supply Chain Portfolio, ensuring quality standards are achieved and maintained at suppliers through management, and monitoring. This role has both site and global interactions, as well as, use of all Global Quality Systems including (NC/CAPA, Audit, Change Control, Escalation, etc.) Acting as the Single Point of Contact (SPOC) for Supplier Quality at the Athens, GA site.

Key Responsibilities:Planning, execution, and documentation of the qualification and monitoring for suppliers who are sourcing APIs, API materials or DP materials such as excipients, raw or packaging materials, to the Janssen Supply Chain for the manufacture of Intermediates, APIs, or drug products respectivelySurveillance on the quality and compliance status for all suppliers under the Account OwnershipPerforming audits, technical visits, and proactive engagements at suppliers and external manufacturersManagement of Change related to supplier and/or external manufacturers (change assessor, action executioner, change approvers)Assessment of deviations, corrective and preventative actions (CAPAs), and complaints concerning suppliers and external manufacturersProvision of all information needed for the release/reject of suppliers in SAP (SAP master data)Establishment of JJ Quality requirements and Quality agreements and periodic review of Quality AgreementsQualification of suppliers for new product introductionsPeriodic performance measurement for suppliers; including face to face meetingsProvide support to JSC local Site during Customer and HA inspections as neededEnsure the supplier Specification agreement and approval managementThey consistently work with external business partners for the purpose of driving the development of core process reliability at external sites.Act as SPOC (single point of contact) for local JSC site, representing EQ-SQ in Site related matters.Involvement in Change Management, escalations, compliance issues, recalls, field action that are related to suppliers and/or to the local JSC siteBuild an accurate connection with the local JSC site establishing periodical meeting with the site Quality Organization to get and provide updating/alignment about the RR and any shared activities/objectivesConnect periodically (weekly is recommended) with local JSC site, local planning, Global procurement (Quartet approach) to discuss and review of the Supplier Quality ongoing performanceEnsure to reach out all appropriate members of EQ that could be requested by the site or any stakeholder (e.g. HA inspection, Escalation, significant investigation)During the HA inspections: Support the local site (in presence), being the reference for any SQ related activities as:

Education:

A minimum of a Bachelors Degree, preferably with a Science or Engineering focusExperience and Skills:

Required:

A minimum of 6 years of experience in quality management, production, quality control, or RD in a pharmaceutical and/or biotechnology environmentProven experience in leading external manufacturing operations or Quality Assurance for external manufacturingAbility to collaborate with internal operating companies and RD partners on a wide variety of product, process, project and compliance related issues.Works with internal JSC functional groups to broker the vital technical support for external partnersInteractions are required with Tech Ops, PDMS, Procurement, EHS, Planning, the different JSC manufacturing sites, but also with the other quality groups within JSC and on enterprise level, such as Compliance, Quality unit API manufacturing, Quality systems and the different Qualified persons.Familiar with GMP – and International Conference on Harmonization (ICH) - regulationExpert demonstrating extensive knowledge and skills to provide mentorship to others and develop balanced improvements in EQ-SQPartners with Enterprise and JSC leaders to establish process improvements and pro-active quality achievements.Exposure to regulatory authorities’ inspectionsOther:This position is anticipated to have up to 25% travel

Johnson Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.

Education:

A minimum of a Bachelors Degree, preferably with a Science or Engineering focusExperience and Skills:

Required:

A minimum of 6 years of experience in quality management, production, quality control, or RD in a pharmaceutical and/or biotechnology environmentProven experience in leading external manufacturing operations or Quality Assurance for external manufacturingAbility to collaborate with internal operating companies and RD partners on a wide variety of product, process, project and compliance related issues.Works with internal JSC functional groups to broker the vital technical support for external partnersInteractions are required with Tech Ops, PDMS, Procurement, EHS, Planning, the different JSC manufacturing sites, but also with the other quality groups within JSC and on enterprise level, such as Compliance, Quality unit API manufacturing, Quality systems and the different Qualified persons.Familiar with GMP – and International Conference on Harmonization (ICH) - regulationExpert demonstrating extensive knowledge and skills to provide mentorship to others and develop balanced improvements in EQ-SQPartners with Enterprise and JSC leaders to establish process improvements and pro-active quality achievements.Exposure to regulatory authorities’ inspectionsOther:This position is anticipated to have up to 25% travel

Johnson Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.