Manager Supplier Quality

Johnson & Johnson Innovative Medicine•Athens, GA

22h•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

Ensures business, quality and compliance goals adhere to Johnson and Johnson (J&J) policies, enterprise standards and government-issued environmental, health, safety, quality and regulatory policies and guidelines.
Represents the J&J credo and quality values in contact with the suppliers and will comply with the J&J regulations for ethics and business conduct to strengthen the reputation of J&J.
Acts as quality partner for all API and DP J&J Innovative Medicine Supply Chain (IMSC) manufacturing sites.
Manages Contractors / SQ team with lower PG and Indirect reports.
SPOC (Site Point of Contact): Represents 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.
Ensures 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.
Manages stakeholder management, collaboration efforts between EQ and corresponding J&J IMSC site with the exposure to regulatory authorities’ inspections.
Builds collaboration and teamwork across the local and global J&J IMSC organization, and interfaces External Quality with the corresponding J&J IMSC site.
Provides SPOC support and acting as a leadership role J&J site (e.g. J&J IMSC Athens site).
Has the Quality oversight responsibility of the assigned Supplier, part of J&J IMSC Portfolio.
Primarily manages Medium Critical Suppliers (e.g. Comprehensive Oversight).
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.).
Leads low/ medium Impact Projects typically from EQSQ (that could be linked to the annual company and division goals) or from a J&J IMSC site.
Leads and participates in strategic and optimization initiatives to improve EQ-SQ management processes.
Acts as a core member of a business or quality project key to the organization.
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.
Acts 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).
Support the local site (remote/ in presence) during HA inspections, 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.
Support the site providing SQ data (for Supplier in scope of SQ) for the Audit preparation and during the execution during Customer/JJRC inspection.
Facilitate the connection between the ECL/ EM FF Account Owner and the site, for each to explain their own process during Customer/JJRC inspection.