Manager Supplier Quality

Description

• Performing audits, technical visits, and proactive engagements at suppliers and external manufacturers.
• Management 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 manufacturers.
• Provision of all information needed for the release/reject of suppliers in SAP (SAP master data).
• Establishment of J&J Quality Requirements and Quality Agreements and periodic review of Quality Agreements.
• Qualification of suppliers for new product introductions.
• Periodic performance measurements for suppliers; including face-to-face meetings.
• Provide support to J&J IMSC local Site during Customer and HA inspections as needed.
• Ensure the supplier Specification agreement and approval management.
• Consistently interfaces 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 J&J IMSC 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 J&J IMSC site.
• Build a proper connection with the local J&J IMSC site establishing periodical meetings with the site Quality Organization to get and provide updating/alignment about the R&R and any shared activities/objectives.
• Connect periodically (weekly is recommended) with local J&J IMSC site, local planning, Global procurement (Quartet approach) to discuss and review of the Supplier Quality on going performance
• Make sure 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 (remote/ in presence), being the reference for any SQ related activities as:

• Presentation of the SQ management process (e.g. 5’5s)
• Facilitate the connection between the ECL/ EM FF Account Owner and the site, for each to explain their own process
• During the Customer/JJRC inspection:

• Support the site providing SQ data (for Supplier in scope of SQ) for the Audit preparation and during the execution.
• Facilitate the connection between the ECL/ EM FF Account Owner and the site, for each to explain their own process.

Qualifications

Highest qualification: University

• A minimum of 8 years of experience in quality management, production, quality control, or R&D in a pharmaceutical and/or biotechnology environment with proven experience in managing external manufacturing operations or Quality Assurance for external manufacturing.
• Refer to supporting documents for Summary of Experience (SoE)
• Frequently collaborates with internal operating companies and R&D partners on a wide variety of product, process, project and compliance related issues.
• Interfaces with internal J&J IMSC functional groups to broaden the necessary technical support for external partners.
• Interactions are required with MSAT, Material Science, Procurement, EHS, Planning, the different J&J IMSC manufacturing sites, but also with the other quality groups within J&J IMSC 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) - regulation
• Expert demonstrating comprehensive knowledge and skill set to provide guidance to others and develop sustainable improvements in EQ-SQ
• Selection, Qualification and Monitoring of Suppliers and EM
• Activities linked to Supplier Quality Management
• Training & development of new hires.
• Partners with Enterprise and J&J IMSC leaders to establish process improvements and proactive quality achievements.
• Exposure to regulatory authorities’ inspections