Easter Seals Jobs

Senior Manager Supplier Quality - 2406193890W

Description

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:

• Surveillance on the quality and compliance status for primarily Highly Critical Suppliers (e.g. Increased 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 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

• 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 JJ Quality requirements and Quality agreements and periodic review of Quality Agreements

• Qualification 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

• Provide input to and represent EQ at the periodic quality management review meetings at the site

• 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.

• Act as SPOC (single point of contact) for local JSC 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 JSC site

• Build a proper connection with the local JSC site establishing periodical meeting 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 JSC 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 (in presence), being the reference for any SQ related activities as:

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

Primary Location Europe/Middle East/Africa-Netherlands-South Holland-Leiden

Organization Janssen Biologics (7266)

Job Function Quality Assurance

Req ID: 2406193890W