SVP, Quality Assurance

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Requirements:

• Bachelor's degree in pharmacy, chemistry, biology, or related field; advanced degree preferred.
• Minimum of 15 years of progressive experience in quality assurance roles within the pharmaceutical industry.
• At least 5 years in a senior leadership position.
• In-depth knowledge of GXP, ICH guidelines, and regulatory requirements.
• Proven track record of leading quality assurance teams.
• Strong understanding of quality risk management principles.
• Excellent leadership and communication skills.
• Demonstrated experience in leading regulatory inspections.
• Strategic thinker with strong analytical skills.
• Ability to travel regularly.

Responsibilities:

• Overall responsibility for the development and implementation of the vision and strategy for the quality function.
• Manage and mentor a high-performing Quality organization.
• Develop comprehensive GXP quality assurance strategies.
• Ensure readiness for PAI and BIMO inspections.
• Oversee quality management systems including document control and CAPA.
• Collaborate with cross-functional teams to integrate quality processes.
• Drive quality risk management initiatives.
• Promote a culture of quality throughout the organization.