Systems Validation Specialist II

Support efforts to define, adopt and oversee compliance to processes and standards as the fundamental baseline for technology solution development, validation and delivery. Supports efforts, in collaboration with the business to monitor, identify and implement continuous process improvement across all technology business units.

Support validation efforts and provides expertise to ensure technology solution projects adhere to established standards and quality expectations. Supports activities to develop and perform assessments on technology solution projects which are low or medium regulatory risk systems to identify and mitigate risks and prevent quality concerns.

Support monitoring and maintenance of oversight for the selection and implementation of technology solutions for quality management in support of delivery of products and services to customers. Supports the vision and direction for the development and implementation of Parexel’s business intelligence infrastructure.

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 solutions.
• Alongside the business and team leads, leads activities to identify low/medium risk/value improvements for process architecture, subject to quality oversight, including Standard Operating Procedures, Manuals and other adjunct documentation in support of the quality system.
• Supports in the development, implementation and continuous improvement of the training and adoption program focused on infrastructure, and related change control and problem management processes. Collaborates with stakeholders to

Technology Solution Project Quality Oversight

• Assists 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 project, 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.
• For 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 actions.
• Supports Change Control Board (CCB) team members, responsible for authorizing or rejecting change requests from a technology quality and validation perspective

Commercial Services

• Supports audit/inspection hosts with planning, coordination and provides standard presentation for covering Technology Solution Life Cycle and general IT area in audit.
• Assists audit/inspection hosts in collation and finalization of audit responses.
• Assists 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 maintenance
• Support activities for development of risk management processes in line with industry best practices and standards.
• Support Requests For Information and proposal activities with respect to review and updating of information to align with quality and compliance standards.

Skills:

• Entry/mid-level experience in computer technology quality and compliance (including computerized system validation) and the pharmaceutical industry across multiple disciplines within Clinical Drug Development (Phase I/II/III/IV) and/or Manufacturing.
• Basic knowledge of continuous improvement methodologies.
• Exhibits competency across core project management activities.
• Excellent interpersonal, verbal and written communication skills, business understanding, negotiation skills and strong organizational skills.
• High ability to work in a customer-focused, fast-paced and rapidly changing environment with the high ability to prioritize workload and manage multiple and varied tasks with enthusiasm and supervision.
• Highly motivated, seeks opportunities for development, client-focused, having the ability to work with guidance on own initiative.
• Exhibits a sense of urgency when addressing problems and ensures completion of commitment.
• Culturally aware and ability to think and work globally.
• Intermediate desktop software skills (MS Office, Excel, Adobe PDF etc.)

Knowledge and Experience:

• Entry/mid-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, or 3+ years clinical research experience