- 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 current 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
EEO Statement
Qinecsa is an equal opportunity employer. Qinecsa evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status, or any other legally protected characteristic.