Lead Global QA Policies: Take the lead in generating global Quality Assurance policies, offering guidance on regulatory interpretation and application. Influence internal practices and ensure policies align with evolving regulations.
Subject Matter Expertise: Provide in-depth expertise on niche regulatory topics, offering guidance to internal teams, clients, and regulatory authorities. Serve as the point of contact for regulatory audits and inspections.
External Audits/Inspections: Host and lead external audits, including regulatory inspections, strategic client audits, and country-specific inspections. Ensure timely and comprehensive responses to audit findings.
Quality Metrics Continuous Improvement: Oversee the reporting of quality metrics and coordinate the implementation of corrective actions. Lead initiatives aimed at improving compliance and efficiency through process improvements.
Quality Initiatives: Manage and participate in global Quality initiatives designed to enhance QA practices and improve organizational efficiency.
Support QA Manager: Act as a backup for the QA Manager, ensuring all QA responsibilities are met. Provide monthly activity reports and support other QA activities as needed.
Compliance Monitoring: Ensure all Regulatory Compliance and Quality Assurance (RCQA) responsibilities are followed in accordance with controlled documents and industry standards.
Additional Duties: Perform other QA-related duties as assigned by management, contributing to the success of the broader organization.
Experience:Minimum of 8 years of experience in the regulatory environment, particularly in GXP roles (Good Clinical, Good Manufacturing, Good Laboratory Practices).
Expertise in regulatory requirements , with detailed knowledge of specific regulations (or multiple regulations) and their application to clinical research.
Experienced Lead Auditor , capable of managing external audits and inspections, and ensuring compliance with regulatory standards.
Proven track record of strategic communication with clients and regulatory authorities.
Strong background in leading process improvement initiatives and driving continuous quality enhancements within organizations.
Qualifications:Minimum Required:
A Bachelor s Degree in Pharmacy, Chemistry, Biology, or a related field.
Postgraduate degree (MSC or equivalent) in a science or management-related discipline is preferable but not required.
Equivalent professional experience may substitute educational requirements.
Desirable Skills:
Strong leadership abilities, particularly in managing cross-functional teams.
Excellent communication and interpersonal skills to effectively engage with clients and regulatory bodies

QA Compliance Lead

Job Description

Required Skills