Manager EQ Supplier Quality

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are our expertise in Innovative Medicine and MedTech we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for more at .

As guided by Our Credo Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson we respect the diversity and dignity of our employees and recognize their merit.

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:

Associates 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

Required Experience:

Manager

Employment Type : Full-Time
Experience: years
Vacancy: 1