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Job Function:

Quality

Job Sub Function:

Supplier Quality

Job Category:

Professional

All Job Posting Locations:

Schaffhausen, Switzerland

Job Description:

Essential Job Duties and Responsibilities

 

This role ensures business, quality and compliance goals adhere to J&J policies, enterprise standards and government-issued environmental, health, safety, quality and regulatory policies and guidelines.

Represents the JNJ credo and quality values in contact with the suppliers and will comply with the JNJ regulations for ethic and business conduct to strengthen the reputation of J&J.

 

The responsibilities are within the EQ-SQ organization, that is the 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 IMSC manufacturing sites.

This position requires knowledge of all categories used at the corresponding to the IMSC site.

This position may manage Contractors / SQ team with lower PG and Indirect reports.

 

·       Account Owner (50 - 80% of time) :

EQ-SQ member having the Quality oversight responsibility of the assigned Supplier, part of IMSC Portfolio.

Quality and Compliance lead ensuring quality standards are 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 EQ (that could be linked to the annual company and division goals) or from all IMSC site

• Lead and participate in strategic and optimization initiatives to improve EQ-SQ management processes

 

·       People Management (5 - 20% of time):

Directly managing, coordinates and coaching people as Contractors / SQ team with lower PG and Indirect reports

 

 

·       GQRM Role ( 5% of time)

This position may require the oversight/coordination of Medium Critical Suppliers as Global Quality Relationship Manager .

Act as Global Quality Relationship Manager for the assigned related Suppliers providing a single aligned voice for supplier quality performance within J&J enterprise network

 

 

·       Example of Jobs

• 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 J&J Innovative Medicine 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  qualification audits, technical visits, and coordination of monitoring audits at external  suppliers

• 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

• Provision of all information needed for the release/reject of suppliers in SAP (SAP master data)

• Establishment of JNJ Quality requirements and Quality agreements and periodic review of Quality Agreements

• Coordination of Qualification activities for new product introductions

• Periodic performance measurement for suppliers; including face to face meetings

• Provide support to IMSC local Site during Customer and HA inspections as needed

• Ensure the supplier Specification agreement and approval management

• He/she consistently interfaces with external business partners for the purpose of driving the development of core process reliability at external sites.

• Involvement in Change Management, escalations, compliance issues, recalls, field action that are related to suppliers.

• undefined

Minimum Qualification

 

• Minimally basic degree in Science, Engineering and Technical subjects.
• Excellent verbal and written communication skills, including ability to effectively communicate with internal and external customers.
• Excellent computer proficiency e.g MS Office, SAP
• Excellent analytical skill to identify gaps and root causes of issues, and think out of the box to develop a solution.
• Must be able to work independently with minimum supervision to meet tight deadlines, and maintain a positive attitude.

 

Education:

 

·         Associate’s Degree:       Required   

·         Bachelor Degree:           Required     Details : Science, Pharmacy or Eng. Preferred

·         Doctorate:                     Desirable     

·         Other Certifications:       Required     Details  : English

Experience:

A minimum of 5 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

 

Competency / skill requirements:

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 IMSC functional groups to broker the necessary technical support for external partners.

Interactions are required with MSAT, DPDS, Procurement, EHS, Planning, the different IMSC manufacturing sites, but also with the other quality groups within 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

Partners with Enterprise and IMSC leaders to establish process improvements and pro-active quality achievements.

Exposure to regulatory authorities’ inspections

 

 

Required Skills:

 

 

Preferred Skills:

Coaching, Collaboration, Compliance Management, Controls Compliance, Performance Measurement, Process Improvements, Product Testing, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Quality Validation, Relationship Building, Stakeholder Engagement, Standard Operating Procedure (SOP), Technical Credibility, Vendor Selection