Lead (Non-managerial) Technology Quality Systems
il y a 4 semaines
The Lead of Systems & Infrastructure Assurance - Research & Development/Clinical, 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 is a non-managerial function without direct reports.
**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.
**Qualifications**:
**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 trend-spotting
**Professional Proficiencies**:
- Sophisticated problem-solving 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 co-located
**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**:
- Provides quality guidance and support to project and/or base business support teams
- Responsible for the management of consultants and outside service providers assigned to support TQ in project teams
- Works with TQ&C leadership and pillar leaders to nurture future leaders and create opportunities to grow
**Degrees and Years of Experience**:
- A Bachelor’s degree in Science, 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 end-to-end Validation programs like LIMS, CAPA, MES, PLM, SAP, LMS, Complaints Handling, and Change Control is required
- Experience authoring or approving validation protocols, non-conformities, Change Requests, SOPs, Validation Plans and Reports is required
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