Manager Supplier Quality

Johnson & Johnson Innovative Medicine•Athens, GA

1d•Onsite

About The Position

Johnson & Johnson is currently recruiting for a Manager Supplier Quality! This position will be located in Athens, GA. About Innovative Medicine: Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at https://www.jnj.com/innovative-medicine

Requirements

A minimum of a Bachelors or equivalent University degree is required with a focus in Science or Engineering preferred.
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.
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

Nice To Haves

Masters or Advanced degree preferred

Responsibilities

SPOC (Site Point of Contact): EQ-SQ member to represent EQ (External Quality organization) to each J&J IMSC sites/ Stakeholders/partners and to EMs located to ASPAC (with or without LOC involvement) where suppliers used are under EQ- SQ responsibility.
Quality and Compliance lead to ensuring quality standards achieved and maintained at suppliers through management, and oversight on Quality Operations functions for external business partners.
This oversight includes ensuring continuous compliance with relevant regulatory health authority requirements, effective risk management, strategy development and execution, and effective collaboration between research & development (R&D), Operations, Global Procurement, Manufacturing Sciences and Technology (MSAT), Material Science, Regulatory Affairs and other technical disciplines.
Functions and activities include quality assurance review and approval functions (such as Change Control, Deviation Handling), compliance audit activities, creation and management of risk mitigation plans for suppliers.
This position requires stakeholder management, collaboration efforts between EQ and corresponding J&J IMSC site with the exposure to regulatory authorities’ inspections.
This position requires the ability of building collaboration and teamwork across the local and global J&J IMSC organization, and interfaces External Quality with the corresponding J&J IMSC site.
This position provides SPOC support and acting as a leadership role J&J site (e.g. J&J IMSC Athens site).
EQ-SQ member having the Quality oversight responsibility of the assigned Supplier, part of J&J IMSC Portfolio.
Quality and Compliance lead to ensuring quality standards achieved and maintained at suppliers through management, and oversight on Quality Operations functions for external business partners.
This position will primarily manage Medium Critical Suppliers (e.g. Comprehensive Oversight) as: - Surveillance on the quality and compliance status for primarily Medium Critical Suppliers (e.g. Comprehensive Oversight) - Activity support for the assigned suppliers on any related activities (e.g. impacted change control management / deviation / escalation/ complaint handling / Specification alignment / Quality Agreement updating etc.)
Lead and participate in strategic and optimization initiatives to improve EQ-SQ management processes
Directly managing, coordinating and coaching people as Contractors / SQ team with lower PG and Indirect reports
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 respectively.
Surveillance on the quality and compliance status for all suppliers under the Account Ownership.
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.