Quality Assurance Manager (Pharma)

Main Purpose

Lead and manage the Quality Management System (QMS) to ensure that all manufacturing processes and products comply with national and international regulatory standards, as well as with the company's own quality policies. The ultimate goal is to ensure the safety, efficacy, and quality of our animal health pharmaceutical products.

EXPERIENCE

• Leadership and Team Management: Proven ability to lead, mentor, and motivate a quality assurance team.
• Regulatory Compliance: In-depth knowledge of Good Manufacturing Practices (GMP) and other relevant regulations from authorities such as FDA, EMA, SENASICA, SAGARPA.
• Quality Systems: Expertise in managing deviations, Corrective and Preventive Actions (CAPAs), change controls, and out-of-specification (OOS) investigations.
• Auditing and Documentation: Experience in preparing for and conducting internal and external audits, as well as maintaining meticulous quality documentation.
• Continuous Improvement: A proactive approach to identifying and implementing process improvements.

COMPETENCIES

• Analytical Thinking: Strong ability to analyze complex data and situations to make sound, evidence-based decisions.
• Problem-Solving: Excellent skills in identifying root causes of problems and implementing effective solutions.
• Communication: Exceptional written and verbal communication skills to interact with all levels of the organization and external regulatory bodies.
• Attention to Detail: Meticulous and thorough, with a strong focus on accuracy and quality.
• Proactivity and Initiative: Ability to anticipate issues and take action before they become major problems.

PROFILE

• Bachelor's degree in Chemistry, Pharmacy, Biology, or a related scientific field.
• Minimum of 5 years of experience in a quality-related management role within the pharmaceutical industry, preferably in animal health.
• Advanced proficiency in English is required (C1).
• Strong leadership skills with a track record of successfully managing quality teams.
• Demonstrated ability to handle regulatory inspections and enforce quality standards.