The Role
Lead QA activities for pharmacovigilance/clinical quality: implement and monitor GxP (GCP, GVP, GMP, GDocP), manage CAPAs, deviations, investigations, change control, audits, risk and continuous improvement; review and approve CAPA closures, report metrics to management, and participate in governance. Clinical operations knowledge preferred.
Summary Generated by Built In
Primary responsibilities include:
- Understanding GXP requirements such as (but not limited to) GCP, GVP, GMP, GDocP etc. and implementing/ monitoring them for QA function, as applicable.
- Facilitating the process of initiation of investigations and CAPAs, monitor progress and perform reviews/approvals including stakeholder management for closure of CAPAs.
- Ensuring that CAPA procedures and requirements are followed and met. Uphold standards for quality and compliance in pharmacovigilance.
- Performing QA functions pertaining to (but not limited to) Change management, CAPA, Deviation, Internal Audits, External Audits, Risk management, Innovation and Continual improvement.
- Escalating and involve stakeholders for resolution as needed, issues impacting the progress toward completion of investigations, root cause analysis, impact analysis, and closure of CAPA Records.
- Reviewing evidence and approve closure of CAPA plans and effectiveness monitoring plans.
- Facilitating regular CAPA status and metric reports to ensure senior management awareness.
- Participating in governance/oversight activities including trend assessment or other quality review.
- Knowledge in the area of Clinical Operations is preferred.
Mandatory Skills:
- Quality Assurance
- Nonconformance management (CAPA, Deviations, Issues)
Preferred Skills:
- GCP
- Stakeholder management
- Conflict Resolution
- Problem Solving
Skills Required
- Understanding and implementing GxP requirements (GCP, GVP, GMP, GDocP)
- Quality Assurance experience
- Nonconformance management (CAPA, Deviations, Issues)
- Facilitating investigations and CAPAs, monitoring progress, reviewing and approving closures
- Change management, Internal and External Audits, Risk management, Continual improvement
- Stakeholder management
- Conflict resolution
- Problem solving
- Knowledge in Clinical Operations
ClinChoice Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about ClinChoice and has not been reviewed or approved by ClinChoice.
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Flexible Benefits — Flexible arrangements, including telecommuting and flextime with no core hours in some regions, are highlighted for many roles. Feedback suggests flexibility is commonly available but depends on role and location.
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Leave & Time Off Breadth — Vacation, personal, and sick days are part of the core package, with some markets granting paid leave from the date of hire. Feedback suggests time off is standard-to-decent across locations, though specifics vary.
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Healthcare Strength — Health coverage is positioned as a core benefit, with some accounts describing overall benefits as full or good. In the U.S., healthcare sits within a conventional CRO package alongside medical, dental, and vision.
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The Company
What We Do
ClinChoice is a global full-service Contract Research Organization (CRO) specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies, aiming to accelerate the development and commercialization of innovative drugs and devices.
