Director Technical Quality and Compliance
Global healthcare company operating Innovative Medicine and MedTech businesses, including a robotic-assisted bronchoscopy platform.
About Johnson & Johnson
Johnson & Johnson develops medicines, therapies, medical devices and health technologies across oncology, immunology, neuroscience, cardiopulmonary, cardiovascular, orthopaedics, surgery and vision.
Skills
Candidate Availability
Required and preferred rules are kept separate and reflect the wording in the original posting.
About the Role
You will lead Technology Quality and Compliance activities for regulated systems. You will ensure quality standards and global regulatory requirements are met, embed quality and controls into design and development, guide project teams, and oversee timely, high-quality system delivery. You will support applications and cloud infrastructure, partner with regional leads, and lead global cross-functional teams.
Requirements
- 10-12 years of experience leading GxP computerized systems validation in a regulated industry
- Deep understanding of GxP regulations, data integrity, SDLC governance, validation lifecycle management, electronic records and signatures, audit trails, and inspection readiness
- Thorough knowledge of global cGMP regulations and computerized systems requirements
- Bachelor’s degree in Computer Science, Information Systems, Business Administration, or a related field
- English proficiency
- Ability to travel internationally at a moderate level
Responsibilities
- Ensure quality standards and global regulatory requirements are met
- Embed quality, controls, and automation into design and development activities
- Provide Technology Quality and Compliance guidance to project teams
- Drive the implementation and maintenance of systems on time, within budget, and at high quality
- Provide end-to-end Technology Quality leadership for applications and cloud infrastructure
- Lead quality approaches and hold teams accountable for end-to-end system support
- Partner with regional leads on the Technology Quality and Compliance operating model
- Lead global cross-functional teams