Lead, S&ia Mfg and Lab Services - Beerse, België - Johnson & Johnson

Johnson & Johnson

Geverifieerd bedrijf

Beerse, België

1 week geleden

Geplaatst door:

Sophie Dubois

beBee Recruiter

Beschrijving

Johnson & Johnson Services, Inc. is recruiting for
a Lead, Manufacturing & Laboratory Services Technology, Quality, & Compliance

Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 130 years.

We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people.

With $76.5 billion in 2017 sales, Johnson & Johnson is the world's most comprehensive and broadly-based manufacturer of health care products, as well as a provider of related services, for the consumer, pharmaceutical, and medical devices markets.

There are more than 250 Johnson & Johnson operating companies employing over 125,000 people and with products touching the lives of over a billion people every day, throughout the world.

If you have the talent and desire to touch the world, Johnson & Johnson has the career opportunities to help make it happen.

The Lead of Manufacturing & Laboratory Services is responsible for guiding and managing project teams in building and executing quality into enterprise wide systems, tools, services, and/or infrastructure through the end-to-end systems lifecycle (design, develop, implement, maintain, retire)

The Lead of Manufacturing & Laboratory Services is responsible for guiding and managing project teams throughout the creation of the validation strategy, design/configuration and test execution activities by ensuring quality is built into the end to end life-cycle of the platform (design, develop, implement, maintain, retire).

As a trusted partner across the Technology Quality & Compliance organization, this role requires strong collaboration skills at project team levels and is expected to provide process improvement recommendations to ensure agility in CSV execution.

Key Responsibilities:

Owns the quality approach of systems and ensures teams are accountable for delivering an endtoend support model.
Ensures J&J quality standards and global regulatory requirements are being met.
Contributes to the creation of strategies for the qualification and validation of existing and new emerging technologies.
Provides compliance guidance to the project teams to ensure successful delivery of the project endtoend.
Ensures a high degree of inspection readiness in support of internal audits and health authority inspections.
Responsible for proactively identifying and working with management to onboard consultant resources to support ongoing and upcoming initiatives/projects on an as needed basis.
Reviews and approves validation work, such as but not limited to Compliance Plans, User Requirements/User Stories, System Tests, User Acceptance Tests, Traceability Matrices, and Compliance Reports including final release and approval for production use.

Qualifications:

A minimum of a Bachelor's degree or higher in Computer Science, Engineering, Information Systems, Business Administration or other related field
required:
A minimum of six (6) years of relevant experience is
required:
Excellent communication skills is
required:
Solid grasp of PMO, SDLC, GAMP 5, and/or ITIL frameworks is
required:
Strong collaboration and influencing skills is
preferred:
Solid grasp understanding of Global and Regional GxP Regulations is
preferred:
Proficiency in Agile Methodology is
preferred:
Experience in pharmaceutical/medical device/biotech industry, with direct experience in Healthcare Technology activities is
preferred:
Experience in running large scale endtoend Validation programs like LIMS, Empower, CAPA, MES, PLM, SAP, LMS, Complaint Handling, and/or Change Control is
preferred:
Experience authoring or approving validation protocols, non-conformities, Change Requests, SOPs, Validation Plans and Reports is
preferred:
Proficiency using the following tools : JIRA, HPALM, Xray, Jenkins, qTest Selenium is **preferred