SR Compliance Specialist - GXP/GLP at Pharmaceutical Product Development (PPD)

Summarized Purpose: 

Executes quality and compliance strategies and initiatives across the organization. Manages the tracking and reporting of quality and compliance activities. Maintains tools and materials, serves as project lead, and provides mentoring and expertise to advance the vision of the department.

Essential Functions: 

• Liaise with lab operations and lab QA to provide support, mentoring, training regarding SOP system, standards, and process
• Provide back-up SOP administration for PTO coverage and high volume
• Researches and addresses issues, tracks metrics and maintains reports and documentation related to quality and compliance activities.
• Leads quality and compliance processes and ensures appropriate execution and completion.
• Leads smaller projects and/or some process/quality improvement initiatives.
• Communicates with representatives from other departments to ensure quality and timelines are maintained with respect to compliance activities (e.g., client audits, CAPA and/or procedural documents).
• Mentors staff and serves as a team lead for group projects or process improvement initiatives.

Job Qualification

Education and Experience: 

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification
• Previous experience with writing and managing controlled documents, such as SOPs, that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years).

Knowledge, Skills and Abilities: 

• Experience writing and managing SOPs 
• Experience with Electronic Document Managment Systems (EDMS)
• Experience working with cross-functional groups
• Excellent oral and written communication skills
• Strong organizational and time-management skills
• Extensive knowledge of the clinical trial process
• Comprehensive knowledge and understanding relevant regulations and guidelines
• Demonstrated problem solving skills
• Excellent attention to detail
• Strong computer skills: ability to learn and become proficient with appropriate software
• Demonstrated ability to multitask and prioritize competing demands/workload
• Proven flexibility and adaptability