Manager EQ Supplier Quality
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 in order 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 knowledge of all categories used at the corresponding to the JSC 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 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 Medium and high Critical Suppliers (e.g. Comprehensive Oversight) as:
- Surveillance on the quality and compliance status for primarily Medium & High 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/follow up of supplier improvement activities etc. )
- Project Management (10 - 30% of time) :
- This position may Lead low/medium/high Impact Projects typically from EQ (that could be linked to the annual company and division goals)
- This position may give support to New Product Introduction projects
- 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 delivering devices and device components and 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
- Execution of qualification audits, performing 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 approver)
- 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 JJ Quality requirements and Quality agreements and periodic review of Quality Agreements with suppliers
- Coordination of Qualification activities of suppliers for new product introductions
- Periodic performance measurement for suppliers, including face to face meetings
- Provide support to JSC local Site during Customer and HA inspections as needed
- Ensure the supplier specification agreement is in place
- He/she consistently interfaces with external business partners for the purpose of driving the development of core process reliability at external sites.
- Bachelor Degree: Required Desirable Details:_Science or Engr Preferred
A minimum of 2 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. Experience and knowledge in handling devices and device components and/or combination products is desireable.
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. Interactions are required with MSAT, PDMS, Procurement, EHS, Planning, material science, the different JSC manufacturing sites, but also with the other quality groups within JSC and on enterprise level, such as Compliance, Quality units, Quality systems and the different Qualified persons.
Familiar with GMP – and International Conference on Harmonization (ICH ) - regulation - Combination Product requirements
Exposure to regulatory authorities’ inspections
The position requires the ability of building collaboration and teamwork across the local and global JSC organization, and it interfaces JSC External Quality with the quality unit of suppliers.