Technology Quality Specialist I

When our values align theres no limit to what we can achieve.

At Parexel we all share the same goal - to improve the worlds health. From clinical trials to regulatory consulting and market access every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us no matter what we do at Parexel contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally we do it with empathy and were committed to making a difference.

Key Accountabilities:

Quality Representative Custodian and leader of the Parexel Quality System. Acts and is recognized as an ambassador for quality across the business and with customers. Supports development implementation and management of Parexel strategic objectives. Contact for management and peers across the business to establish and maintain a communication framework that removes constraints and ensures timely and effective action related to matters of quality. Performs general and administrative tasks including accurate and timely completion of TIME.

Standards & Quality Framework Collaborates with functional leads to design re-engineer implement and adopt the quality framework for the validation and release of interface and the business and team leads leads activities to identify risk/value improvements for process architecture subject to quality oversight including Standard Operating Procedures Polices and other adjunct documentation in support of the quality in the development implementation and continuous improvement of the training and adoption program focused on infrastructure and related change control and problem management processes.

Technology Solution Validation AssuranceAssists in providing guidance consultation and overall expertise to project teams in support of clinical trial and/or validation activities through the applicable lifecycle. Supports others in overseeing monitoring compliance status and activities to ensure compliant state for a Technology business area or portfolio. Supports activities to identify requirements for key validation deliverables including but not limited to validation planning resource estimates risk and impact assessments summary reporting and Electronic Records/Electronic Signature regulations (where applicable).Assists in risk mitigation to identify categorize and define associated risks and their mitigation plan to ensure risks are removed. Supports 3rd part supplier audits reviewing vendor provided validation packages and ensuring technology-related Quality Issues (QIs) provide support to internal customers with QI management with particular emphasis on appropriate description of the issue accurate classification oversight of root cause analysis and consultation on appropriateness of corrective and preventive Change Control Board (CCB) team members responsible for authorizing or rejecting change requests from a technology quality and validation perspective

Commercial ServicesSupports audit/inspection hosts with planning coordination and provides standard presentation for covering Technology Solution Life Cycle and general IT area in audit/inspection hosts in collation and finalization of audit team leads in providing quality and GxP regulatory advice for technologies including risk assessment(s)/ used in a trial or trial program (client account) clarifying customer quality expectations for technologies including for system design/delivery and its maintenanceSupport activities for development of risk management processes in line with industry best practices and Requests For Information and proposal activities with respect to review and updating of information to align with quality and compliance standards.

Skills:

• Entry-level experience in Computer Technology Quality & Compliance including Computerized System Validation (CSV/CSA) within the pharmaceutical and life sciences industry.
• Understanding of Clinical Drug Development processes across Phase I II III and IV studies as well as manufacturing operations in regulated GxP environments.
• Working knowledge of FDA regulations EU regulations and ICH guidelines related to validation compliance and assurance of computerized systems in GxP-regulated areas.
• Understanding of GAMP 5 principles for the validation and assurance of computerized systems including emerging AI-enabled applications.
• Basic knowledge of continuous improvement methodologies and quality-driven process enhancement initiatives.
• Competence in core project management activities including planning coordination tracking and execution support.
• Strong interpersonal verbal and written communication skills with the ability to collaborate effectively across cross-functional teams.
• Good business acumen organizational stakeholder management and negotiation skills.
• Ability to work effectively in a customer-focused fast-paced and dynamic environment while managing multiple priorities and deadlines.
• Self-motivated professional with a proactive approach to learning continuous development and delivering high-quality outcomes.
• Demonstrates a strong sense of ownership urgency and commitment to resolving issues and meeting project objectives.
• Culturally aware with the ability to collaborate and work effectively in global environments.
• Proficient in Microsoft Office Suite (Word Excel PowerPoint) Adobe Acrobat PDF and other standard desktop productivity tools.
• Ability to work independently with appropriate guidance while maintaining compliance quality and operational excellence standards.

Knowledge and Experience:

• 2-3 years of relavant experience
• Entry level Clinical trials and / or Clinical trials and /or research work experience required with emphasis on GCP and technology compliance.
• Familiar in technology as it relates to clinical trial activities including System Life Cycle process and applicable GCP regulations pertaining to Computer Systems.
• Entry knowledge of project management Lean Six-Sigma auditing and/or risk management methodologies

Education:

Educated to degree level (technology biological science pharmacy or other health related discipline preferred) or equivalent qualification.