Commercial Quality Manager Courcelles in Hainaut, Belgium

Commercial Quality Manager Courcelles – 2406215568W

Description

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through 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 humanity. Learn more at https://www.jnj.com/.

Purpose of the role:

This position is responsible for driving development and deployment of the GRID (Global Restricted inventory cage Dashboard), and identify action to reduce and maintain good level of Restricted inventory, collaborate with franchise to identified opportunities. This position will represent CQ to ensure Q&C:

• Ensures and supports Operations of European Distribution Center (DC Courcelles) in Good Distribution Practices in the warehouse.

• Assists the Site Quality Head in implementing and maintaining Quality System DC Courcelles.

• Works in line with Credo Values, Supply Chain and J&J Deliver Requirements.

• Works in line with the J&J Safety, Health and Environmental principles.

• Participates to the process improvement as process owner.

Duties and responsibilities:

Audits & inspections:

• Leads, supports and follows-up of audits and external inspections.

• Supports and actively participates to quality internal/external audits.

• Performs pro-active GAP analysis against applicable requirements and/or regulations and sets-up corrective actions to support business continuity.

• This include audits preparation, audits completion and audits follow-up.

Change control:

• Initiates, assesses and/or approves Change Controls related to DC distribution activities and repackaging activities.

Documentation:

• Writes, (periodic) reviews and/or approves Work Instructions (WI) and Procedures (SOP)

• Collaborates with other departments for documentation content and ensure Good Documentation Practices are followed.

• Archives quality documents and/or repack/relabel records following the record retention period and archiving system.

Improvement:

• Prepares and leads Quality Improvement Plan (QIP) meeting.

• Provides data/information for the Quality Management Review (QMR) meetings

• Supports and performs trend analysis and proposes corrective actions where needed.

• Reviews and improves processes of the QMS, ensures that KPIs are in place.

• Participates to the process improvement as process owner.

Non- conformities & Delivery Service Issues:

• Initiates, assess, investigates, and/or approves Quality Issues, Corrective and Preventive actions and Delivery service issues related to distribution activities to avoid reoccurrences.

• Assess if record is applicable for escalation and initiates appropriate process

Project:

• Participates, follows up and/or leads development of projects implementation in collaboration with Operations, Region and/or Franchises

• Provides QA Team with project progress on a regular basis

QA on the floor:

• Supports operations to work in compliance with GMP (where applicable) and GDP requirements

• Performs Gemba Walks on a regular basis

• Joins weekly operational kick-off

• Works actively and proposes operational improvements

Risk management:

• Identifies, prioritizes and mitigates quality risks related to QA and operational processes

Training & Qualification:

• Delivers qualification to warehouse personnel to ensure operational personnel has an appropriate understanding of the process/activity

• Reviews training curricula and creates training materials (where applicable)

• Assigns appropriate training towards teams

Management:

• Manages the Quality organization in such a way that the short- and long-term objectives are met

• Manages, coaches and develops the team in reaching their quality, business and personal objectives

• Empowers and enables team; leads by example

• Performs regular follow-up in order to help, to coach or to correct when necessary

• Is Responsible for training, supervising and performance management of staff

• Supports hiring

• Ensures adequate resources are available to support business needs

• Trains & develops staff in the execution of their technical and managerial functions

• Establishes and maintains effective working relationships internally and with operations, IT, engineer, purchasing, Q&C, franchises, CQ, … and ensures alignment of objectives and deliverables.

• Ensures all additional base business related activities are performed or supported as per defined plan in the QA weekly team meeting or as agreed during the face to face meetings

Qualifications

Essential knowledge and skills:

• Higher education / Masters degree

• Has been exposed to external inspections and/or JJRC audits

• Extensive QA related experiences within an operational regulated environment with focus on Distribution Center operation oversight.

• Experience as Project workstream lead.

• Knowledge of quality system processes such as Training, Document Management, Change Control, CAPA, Investigation, Audit.

• Analytical thinking, risk assessment, communication, managerial and leadership skills.

• Ability to assess multiple issues, and interpret the compliance and business impact, translating into system and process requirements.

• Warehouse management system

Core competencies required:

• French and English

• Good knowledge of Microsoft Office applications (Word, Excel,)

• Good knowledge of Good Documentation Practices

• Excellent communicator, ability to building a network

• Ables to build strong relationship with internal and external customers

• Team player

• Ables to negotiate and influence

• Problem solver structured & analytical way of working

• Result oriented

• Can work independently, knows the right priorities and escalates issues if needed.

• Excellent verbal and written communication skills

• Ables to manage and coach a team

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

Primary Location Europe/Middle East/Africa-Belgium-Hainaut-Courcelles

Organization GMED (7548)

Job Function Customer/Commercial Quality

Req ID: 2406215568W