Senior Validation Manager
2 weeks ago
Meet is a global leader in the pharmaceutical industry, dedicated to developing innovative therapies that enhance patient care and improve health outcomes. Our commitment to quality, compliance, and operational excellence drives us to continually advance our capabilities in drug development and manufacturing.
We are seeking a strategic thinker with extensive experience in validation processes to lead and manage all validation activities across our pharmaceutical operations in Europe. The ideal candidate will ensure that all validation efforts meet regulatory standards and support the company's commitment to quality and compliance.
Key Responsibilities:
- Develop and execute a comprehensive validation strategy for systems, equipment, and processes in compliance with regulatory requirements (FDA, EMA, ICH).
- Oversee the design, execution, and documentation of validation protocols, including Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and cleaning validations.
- Lead the validation team, including hiring, training, and mentoring staff to build a skilled and motivated workforce.
- Collaborate with cross-functional teams, including quality assurance, engineering, and manufacturing, to ensure effective integration of validation processes into the product lifecycle.
- Review and approve validation documentation to ensure accuracy and compliance with internal SOPs and regulatory standards.
- Conduct risk assessments related to validation activities and provide strategic recommendations to mitigate risks.
- Stay informed on industry trends, regulatory changes, and best practices in validation and quality assurance.
- Foster a culture of continuous improvement and quality excellence within the validation team.
- Manage relationships with external partners and vendors involved in validation activities as needed.
What We Offer:
- Competitive salary and comprehensive benefits package.
- A dynamic, innovative, and collaborative work environment.
- Opportunities for professional development and career advancement.
- A commitment to diversity and inclusion in our workforce.
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