Responsibilities
- Lead and implement the plant’s quality strategy in alignment with global quality standards
- Ensure full compliance with GMP and applicable regulatory requirements (Brazil, US, EU, pharmacopoeia standards)
- Own and continuously improve the Quality Management System (QMS), including audits, CAPA, deviations, and documentation
- Manage and maintain quality certifications (ISO, Halal, Kosher, etc.)
- Act as the primary contact for regulatory authorities and lead inspections
- Oversee customer quality requests, complaints, and ensure timely resolution
- Drive a strong quality culture and continuous improvement mindset across the plant
- Lead, coach, and develop QA and QC teams to ensure high performance and engagement
- Monitor and improve site quality KPIs and dashboards
- Deploy global quality initiatives and share best practices within the quality network
Qualifications
- Master’s degree in Pharmacy, Engineering (Chemical/Technical), or Quality Management preferred
- Minimum of 7+ years of experience in Quality within the pharmaceutical or life sciences industry
- Proven experience managing Quality Assurance and Quality Control teams
- Strong expertise in GMP and regulatory requirements, particularly Brazilian regulations (e.g., RDC 34)
- Experience leading audits and regulatory inspections
- Experience working in an international or matrix organization preferred
- Direct management of 2 employees; oversight of a broader QA/QC organization of up to 20 employees
- Full-time position located in Anápolis, Brazil, operating in both office and manufacturing environments with regular plant floor presence
- Physical demands: ability to work in a manufacturing environment, including standing, walking, and working in varying conditions (hot, cold, noisy), and use of hands and arms for operational tasks with required PPE
Position type/expected hours of work: Full-time. Flexibility in working hours may be required to meet plant and operational needs.
Roquette is an equal‑opportunity employer. All qualified applicants will receive consideration without regard to race, color, religion, sex, national origin, disability, or veteran status.