Lead, S&ia Mfg and Lab Services

**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 end-to-end 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 end-to-end.
- 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.
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**Qualifications**
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 end-to-end 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, Selenium is **preferred**

**Primary Location**
Belgium-Antwerp-Beerse
- **Other Locations**
Europe/Middle East/Africa-Switzerland-Zug-Zug
**Organization**
Janssen Pharmaceutica N.V. (7555)
**Job Function**
Quality
**Requisition ID**
2206036822W