Lead, Complaint Management Tqc - Beerse, België - Johnson & Johnson

Johnson & Johnson

Geverifieerd bedrijf

Beerse, België

1 week geleden

Geplaatst door:

Sophie Dubois

beBee Recruiter

Beschrijving

The Lead of Complaints Management/Event Management/Commercial Systems, is responsible for building and execution of quality into enterprise wide systems, tools, services and infrastructure through the end-to-end lifecycle (design, develop, implement, maintain, retire).

This position is a non-managerial position. Individual must be located in the EU to support customers.

Responsible for:

Ensuring that all J&J quality standards and global regulatory requirements are being met.

This individual will lead the quality approach for systems and ensure teams are accountable for delivering on an end-to-end support model for systems in scope.

The role provides technical and procedural expertise/guidance to the project teams as well as aligning with both internal and external partners.

This position will support internal audits and Health Authority regulatory inspections.

This position will be responsible for the approval of SDLC validation documentation including the approval to release system implementation and/or changes for production use.

This role will lead globally diverse teams in an inclusive environment.

This role serves as a trusted partner across the Technology Quality & Compliance organization, requiring strong collaboration skills at the senior leadership level, and includes making recommendations for improvements relevant to senior level partners.

Leadership Proficiencies:

Strong collaboration, interdependent partnering and influence skills
Able to encourage trust and quickly build credibility
Excellent listening skills and incorporates diverse points of view
Outstanding level of innovative thinking and trendspotting

Professional Proficiencies:

Sophisticated problemsolving skills to assist in maintaining project progress and on design issues
Excellent intellect, strategic and big picture thinking ability, complemented by operational and business planning orientation
Outstanding executive presence, communication and facilitation skills
Ability to team with others and drive towards a common goal
Sets clear performance standards and drives to results
Works effectively in teams that are not geographically colocated

Core Technical Proficiencies:

Proficiency in skills including, Quality Strategy, Applications and Infrastructure, Data Integrity, Quality Theory, Testing, Quality Management Systems
Familiarity and awareness of cybersecurity and privacy principles and implications for quality and risk management
Advanced understanding of Global and Regional GxP Regulations
Solid understanding of PMO, SDLC, GAMP 5, and ITIL frameworks is highly desirable
Knowledge of GxP regulations, including computer system validation, data integrity and medical device regulations
Solid grasp of Agile Development Methodology and DevOps

People Management:

Manages and leads a globally diverse team across geographies, including FTEs and contractors, within a matrixed organization
Identifies critical skills and capabilities required to ensure the development of a highly skilled, high performance team
Responsible for the development of direct/indirect reports including training and mentoring to meet current and future business needs
Works with TQ&C leadership and pillar leaders to nurture future leaders and create opportunities to grow
Mentors talent and helps them grow in their careers

Qualifications:

Degrees and Years of Experience:

A Bachelor's degree in Computer Science, Engineering, Information Systems, Business Administration or other related field required; advanced degree preferred; additional certifications a plus
6+years of progressive experience in the pharmaceutical, medical device, biotech industry, with direct experience in Healthcare Technology activities
Experience in running large scale endtoend Validation programs like LIMS, CAPA, MES, PLM, SAP, LMS, Complaints Handling, and Change Control is required
Experience authoring or approving validation protocols, nonconformities, Change Requests, SOPs, Validation Plans and Reports is required