Quality Assurance Lead

Job Title: Lead, Quality Assurance & Regulatory Compliance

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.

Secondary Responsibilities

Maintain quality service and departmental standards by:

• Reading, understanding, and adhering to organizational standard operating procedures (SOPs)
• Assisting in establishing and enforcing departmental standards

Contribute to team effort by:

• Working with internal staff to resolve issues
• Exploring new opportunities to add value to organization and departmental processes
• Helping others to achieve results
• Performing other duties as assigned

Maintain technical and industry knowledge by:

• Attending and participating in applicable company-sponsored training

Qualifications

Education : Bachelor’s or Master’s degree in Pharma/ life sciences or equivalent in a related discipline

Experience : 6-8 years of relevant experience

Additional Skills

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