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Senior Manager Supplier Quality
Senior Manager EQ - Supplier Quality
The employee is acquainted with the annual company and division goals and is aware of how he/she can influence these through his/her performance.
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 JSC quality unit responsible for Q&C oversight of suppliers in the Global Pharma sector, and acts as quality partner for all API and DP JSC manufacturing sites.
This position requires high SME for all categories used at the corresponding to the JSC site
This position may manage Contractors / SQ Team with Direct and Indirect reports
SPOC Role (40 - 50% of time) :
SPOC (Site Point Of Contact): EQ-SQ member to represent EQ (External Quality organization) to each JSC 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 ensuring quality standards are 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 as well as effective collaboration between R&D, Operations, Procurement, MSAT, Regulatory Affairs and other technical disciplines (e.g. EHS). 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 complex stakeholder management, leading collaboration efforts between EQ and corresponding JSC site with the exposure to regulatory authorities' inspections
This position requires the ability of building collaboration and teamwork across the local and global JSC organization, and interfaces External Quality with the corresponding JSC site.
This position provides SPOC support and acting as a SQ leadership role to support the Leiden site (e.g. JSC Leiden Site within Large Molecule platform) .
Account Owner (30 - 50% of time) :
EQ-SQ member having the Quality oversight responsibility of the assigned Supplier, part of JSC 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 Highly Critical Suppliers (e.g. Increased Oversight) as:
Project Management (10 - 30% of time) :
This position may Lead High Impact Projects typically from EQ (that could be linked to the annual company and division goals) or from Local JSC sites
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 Contractors / SQ Team with Direct and Indirect reports
GQRM Role ( 5% of time)
This position may require the oversight/coordination of High Critical / Complex 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
Qualifications
Minimum Qualification
Experience:
A minimum of 10 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 JSC functional groups to broker the necessary technical support for external partners.
Interactions are required with MSAT, DPDS, Procurement, EHS, Planning, the different JSC manufacturing sites, but also with the other quality groups within JSC 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 exceptional skill set to provide guidance to others and develop sustainable improvements in EQ-SQ
a. Selection, Qualification and Monitoring of Suppliers and EM
b. Activities linked to Supplier Quality Management
c. Training of new people
Partners with Enterprise and JSC leaders to establish process improvements and pro-active quality achievements.
Exposure to regulatory authorities' inspections
We invite you to join our Global Talent Hub, where we keep in touch with people around the world who share our passions for bold innovations and are inspired by our mission of changing the trajectory of human health.
Except as specifically requested by J&J China or legally required, please avoid submitting information in your application which may be deemed as sensitive personal information, which includes biometrics, religious belief, specific identity, medical health, financial accounts, whereabouts, as well as information of minors under the age of fourteen (14), and other information that the breach or illegal use of which may easily lead to the infringement of an individual's personal dignity or harm to personal or property safety.
Processing Method: Conduct talent acquisition management through the unified process and globally connected applications, including storage, use, handling, transmission, and deletion of provided personal information. Overseas recipients will apply appropriate managerial and technical measures to ensure the confidentiality, integrity, and availability of the provided personal information and shall store such personal information to the minimum extent necessary to complete the above purposes.
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You may contact the Personal Information Protection Officer of the J&J China at to exercise your relevant rights to the overseas recipient, including access, correct, copy, or delete your personal information.
Functie: | manager |
Startdatum: | 12-06-2024 |
Ervaring: | Ervaren |
Educatielevel: | HBO |
Contracttype: | Vast |
Salaris: | onbekend – onbekend |
Uren per week: | 1 – 40 |
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