Leader Tq&c Apac

Johnson & Johnson is currently recruiting for a Leader TQ&C APAC (New Consumer Health Company). This position may be located in Mumbai, India or Science Park Drive (Ascent), Singapore.

Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 125 years. We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people.

With $82.1 billion in 2020 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. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch 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. Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer. Johnson & Johnson is the world's most comprehensive and broadly-based healthcare Company, touching the lives of nearly a billion people every day. Our Family of Companies throughout the world compete in consumer, pharmaceutical and medical devices & diagnostics markets and have the skills and resources to tackle the world's most pressing health issues.

The Leader TQ&C APAC 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)
- The individual ensures company quality standards and regulatory requirements are met for the project/product teams under scope of responsibility
- The role is responsible for planning, executing, coordinating and maintaining the validation activities for GxP projects/technology product teams within their scope including approval of SDLC validation documentation, release system implementation and/or changes for production use, providing TQ&C compliance guidance and support to support team members
- The individual reviews and approves SOP, WIs and policies related to regional processes and systems within their scope and supports the incident management/CAPA and NC processes for the region supported
- This position will support internal audits, Health Authority regulatory inspections and system periodic reviews ensuring a high level of inspection readiness for projects/technology products/systems under their responsibility
- Responsible for the management of consultants and outside service providers assigned to execution activities and provides risk-evaluation guidance to TQ&C Leads and consultants to carry out validation of computerized systems and infrastructure.
- Serves as the TQ&C SME for regional CSV requirements, engages with Regulatory Compliance to support regulatory standards and trends monitoring evaluation activities and analyzes impact of guidance documents applicable to the region.

**Qualifications** Requirements**:

- A Bachelor’s degree in Computer Science, Information Systems, Business Administration, or another related field required; relevant experience may be substituted when appropriate; additional certifications a plus
- A minimum of 8-10 years of progressive industry experience, with direct experience in Computerized System Validation (CSV) in GxP environments
- Experience authoring or approving validation deliverables, Non-conformities, Change Requests, SOPs, Validation Plans and Reports
- Knowledge of Quality Management Systems, Data Integrity, cGMP regulations related to CSV
- Experience providing CSV support in at least one of the following areas: medical device software, infrastructure qualification, hosted platforms, emerging technologies (e.g. AI, ML, RPA) or externally facing digital assets (e.g. mobile apps, Websites that include both static and dynamic processing)

**Preferred Requirements/Competencies**:

- Working knowledge of PMO, SDLC, Testing, GAMP 5, and ITIL frameworks
- Working knowledge of data analytics and insights
- Ability to perform work with a high degree of independence in terms of self-management of a variety of tasks
- Solutions oriented, striving for new ways to accomplish goals and pragmatic advising in meeting compliance requirements
- Works effectively in a virtual team environment; comfortable collaborating and communicating with various cross-functional groups

**Primary Location**
India-Maharashtra-Greater Mumbai
- **Other Locations**
Singapore-Singapore-Singapore

**Organization**
Johnson & Johnson Private Limited (8080)

**Job Function**
Quality

**Requisition ID**
2206071412W