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Site Quality Director
2 months ago
Job Title: Site Quality Director
Job Summary:
We are seeking a highly experienced Site Quality Director to oversee our manufacturing facility in the pharmaceutical industry. As a key member of our team, you will be responsible for managing the Quality teams, ensuring compliance with regulatory standards, and driving continuous quality improvement.
Key Responsibilities:
- Leadership and Management: Provide strong leadership to the quality team, fostering a positive and collaborative work environment.
- Quality Strategy: Develop and implement a sustainable quality strategy for the site, aligned with the company's strategic goals.
- Resource Management: Manage departmental activities and resources within budget and timelines.
- Performance Improvement: Drive performance improvements and ensure compliance with regulatory requirements.
- Regulatory Compliance: Coordinate with regulatory authorities and stakeholders.
- Team Development: Mentor and develop the quality team to improve their knowledge and skills.
- Initiative Implementation: Support the implementation of new initiatives and systems.
- Communication: Establish effective communication strategies.
- Troubleshooting: Troubleshoot and contribute to manufacturing and testing issues.
- Reporting: Report on changes in standards and performance.
- Audit Hosting: Host regulatory and customer audits.
- Inter-Site Collaboration: Liaise with the multi-site Quality Director to ensure consistency across manufacturing sites.
About You:
We are looking for a candidate with:
- Significant Leadership Experience: Significant leadership experience in the pharmaceutical industry.
- Pharmaceutical Quality Experience: Extensive experience in pharmaceutical quality, including audit, batch record review, change control, complaint handling, and investigations.
- Time Management: Ability to prioritise work and handle multiple deadlines.
- Regulatory Knowledge: A thorough understanding of pharmaceutical manufacturing, packaging, testing, and distribution processes, as well as global regulatory requirements.
- Inspection Experience: Experience with UK and FDA inspections, client audits, and self-inspections.
- Quality System Implementation: Proven track record of implementing and maintaining quality systems.
- Technical Knowledge: Technical knowledge to support quality and validation decision making.
- Project Experience: Experience working on multi-department projects.
- QP Eligibility: Eligibility for QP status is highly desirable.
- Travel: Occasional global travel may be required.
Company Overview:
We are a leading global specialist in pharmaceuticals, committed to delivering high-quality products. We are known for our expertise in various areas, including endocrinology, dermatology, analgesia, and pain management.
About Consult:
We are a company that provides consulting services to the pharmaceutical industry. We are committed to helping our clients achieve their goals and improve their quality systems.
