
Lead Compliance Specialist
2 weeks ago
We are seeking a seasoned compliance professional to lead our validation efforts.
Job DescriptionKey Responsibilities:
- Compliance Strategy Development: Design and implement comprehensive strategies and processes to ensure product quality and reliability throughout the development lifecycle.
- Cross-Functional Collaboration: Work with development, quality assurance, and other teams to define requirements and priorities.
- Regulatory Compliance: Establish plans, protocols, and procedures in accordance with regulatory standards (e.g., FDA, ISO) and industry best practices.
- Validation Execution: Oversee execution of activities, including IQ/OQ/PQ, software validation, and process validation, ensuring thoroughness and accuracy.
- Risk Management: Perform risk assessments and develop mitigation strategies to address potential product risks related to validation.
- Process Improvement: Drive continuous improvement initiatives to enhance processes, streamline workflows, and increase efficiency.
- Team Leadership: Manage a team of professionals, providing guidance, coaching, and mentorship to ensure their growth and development.
- Training Compliance: Ensure training compliance for self and project team members on customer-related requirements.
About Us: We are committed to excellence and strive to maintain the highest standards in our industry.
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