TQM Quality Specialist II at PharmiWeb.

The Role

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

Quality Representative

• Custodian and leader of the Quality System.
• 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.
• Support internal and client meetings to collaborate with and participate in discussion related to quality.
• Performs general and administrative tasks including timely completion of TIME and travel expense reports.

Clinical Trial & Technology Project Oversight

• Assists in providing guidance, consultation and overall expertise to project teams in support of clinical trials and/or validation activities through the applicable life-cycle.
• Assists in risk mitigation to identify, categorize and define associated risks and their mitigation plan to ensure risks are removed.
• Supports Change Control Board team members responsible for authorizing or rejecting change requests from a technology quality and validation perspective.

Qualifications
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.
• 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.)

Knowledge And Experience

• Entry/mid-level Clinical trials and /or research work experience preferred, 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/mid-level 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.