QA Compliance Lead

3 weeks ago

Mumbai Pune, India Thepharmadaily Full time
Job Description

- 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 experiencein the regulatory environment, particularly in GXP roles (Good Clinical, Good Manufacturing, Good Laboratory Practices).
- Expertise inregulatory 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 ofstrategic communicationwith clients and regulatory authorities.
- Strong background inleading process improvement initiativesand driving continuous quality enhancements within organizations.
- Qualifications:Minimum Required:
- ABachelor s Degreein Pharmacy, Chemistry, Biology, or a related field.
- Postgraduate degree (MSC or equivalent) in a science or management-related discipline ispreferablebut 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

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