Lead, Quality Assurance & Regulatory Compliance

Designation: Lead, Quality Assurance & Regulatory Compliance

Position description: Quality Assurance / Quality Management space in Clinical Domain, especially in Pharmacovigilance /Data Management / Safety areas. Sr. auditor with Gxp audit experience auditing internal & external systems.

Hands on experience and subject-matter-expertise in Clinical Data Management / Life Cycle Safety / Pharmacovigilance. A key contributor in Driving the Organization Towards Pharmacovigilance/Data Management/Safety Regulatory Audits & Inspections.

GVP/GCP/GXP Certification, ISO, ISMS Knowledge preferred

Primary Responsibilities

• Assure that CRO Operations remains in compliance with corporate policies and procedures and all applicable worldwide regulations & guidelines.
• Deploy, Manage & improve quality management system and create awareness across the organization. Plan & roll out regulatory readiness program for eventual regulatory audits.
• Ensure effective execution of the readiness program. Assess the effectiveness of inspection readiness by coordinating and conducting internal and external compliance audits and applicable assessments (e.g. inspection readiness assessments).
• Provide consultation to operations & business enabling functions personnel on Requirements (Organization, regulatory & client) & compliance issues. Impart awareness session on applicable regulations (FDA, MHRA etc.).
• Lead cross-functional teams to help identify potential issues and resolve current issues. Manage compliance issues across organization and escalate issues to Qinecsa QA management as appropriate Directly manage & coordinate internal and external compliance auditing programs at Qinecsa.
• Support Operations staff in the use of integrated quality systems summarize quality reports and provide quality metrics as appropriate.
• Oversee CAPA management & facilitate effective corrective and preventive action (CAPA) closure.
  
  

Additional Responsibilities

• Strong motivational skills and abilities, promoting a team-based approach
• Strong interpersonal and communication skills, both verbal and written
• Strong organizational and leadership skills
• Goal-oriented
• Ability to maintain professional and positive attitude