Sr Compliance Specialist
Core
Establishes and maintains quality systems for investigational new drugs, biologics, and medical devices to ensure compliance with regulatory and customer requirements.
Role type
Senior Quality Assurance Specialist (Compliance)
Builds
Quality systems, SOPs, audit reports, and vendor qualification frameworks
Domain
Life Sciences / Pharmaceutical / Medical Devices
Required skills
Quality system management, Change Control, Deviation management, CAPA, SOP development, Auditing, Vendor qualification, ICH requirements knowledge, APQR management, Training delivery
Preferred skills
Project management, Problem-solving, Cross-functional collaboration, Continuous improvement
Technologies
cGMP, ICH guidelines, Quality Management Systems (QMS)
Responsibilities
Maintain Change Control, Deviation, OOS, CAPA, and Complaint systems; Establish and review Standard Operating Procedures (SOPs); Audit departments for quality system compliance; Oversee vendor qualifications and supplier quality issues; Ensure facility audit readiness; Train employees on cGMP regulations and TFS procedures; Generate and submit APQRs; Participate in cross-functional process improvement projects.
Seniority
Senior, independent contributor