Job Function:
Quality
Job Sub Function:
Supplier Quality
Job Category:
Professional
All Job Posting Locations:
Athens, Georgia, United States of America
Job Description:
Johnson & Johnson is currently recruiting for a Manager Supplier Quality! This position will be located in Athens, GA
Position Summary:
This role 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.
The responsibilities are within the EQ-SQ organization, that is the J&J IMSC quality unit responsible for Q&C oversight of suppliers in the Global Pharma sector, and acts as quality partner for all API and DP J&J Innovative Medicine Supply Chain (IMSC) manufacturing sites.
This position requires knowledge of all categories used at the corresponding to the J&J IMSC site.
This position may manage Contractors / SQ team with lower PG and Indirect reports.
Key Responsibilities:
SPOC Role (15 - 25% of time):
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).
- Account Owner (50 - 80% of time):
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.)
- Project Management (10 - 30% of time):
- This position may Lead 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.
- Lead and participate in strategic and optimization initiatives to improve EQ-SQ management processes
- This position may require acting as a core member of a business or quality project key to the organization.
- People Management (5 - 20% of time):
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.
Qualifications
Education:
A minimum of a Bachelors or equivalent University degree is required with a focus in Science or Engineering preferred. Masters or Advanced degree preferred
Required Skills & Capabilities:
- 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
Required Skills:
Preferred Skills:
