Senior Quality Specialist

Responsible for providing quality, GxP regulatory and validation advice for technologies including risk assessment(s)/ used in a trial or trial program (client accounts) clarifying customer quality expectations for technologies including system design/delivery and its maintenance.

• Collaborates with business development leads in the review of Master

Services Agreements to ensure accuracy/completeness of technology quality content.

• Supports Requests for Information and proposal activities with respect to review and updating of information to align with quality and compliance standards.

Supports project delivery, validation efforts, and provides expertise to ensure clinical trials and/or technology projects adhere to established standards and quality expectations. Supports activities to develop and perform assessments on clinical trials and technology projects to identify and mitigate risks and prevent quality concerns.

QualificationsEntry/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.

• Ability to work in a customer-focused, fast-paced and rapidly changing environment with the ability to prioritize workload and manage multiple and varied tasks with enthusiasm and supervision.

• Highly motivated, seeks opportunities for development, client-focused and 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.)