Quality Assurance Director
Argentina, Brazil or Mexico
QA / QC, Argentina.
Ferring Pharmaceuticals is a research-driven, speciality biopharmaceutical group committed to helping people around the world build families and live better lives. Headquartered in Saint-Prex, Switzerland, Ferring is a leader in reproductive medicine and women’s health, and in specialty areas within gastroenterology and urology. Founded in 1950, Ferring now employs approximately 7,000 people worldwide, has its own operating subsidiaries in nearly 60 countries and markets its products in 110 countries.
In Latin American Region, we are looking for a:
Quality Assurance Director
Your mission: Lead Quality Assurance for regional Affiliates to ensure effectiveness and compliance in the Supply Chain and Commercial Affiliates quality operations.
Your main responsibilities
- Develop and implement the quality strategy, objectives, and plan for the regional / cluster hub. Represent QA in the regional leadership team.
- Coach, motivate and develop effective teams. Promote best practice sharing and ensure seamless communication across regional QA functions and with GQA.
- Chair Quality Review Board (QRB) for regional cluster operations. Issue monthly Quality status reports to monitor local GMP/GDP compliance and report to Senior management.
- Enhance and maintain the Quality and training Systems and ensure effective use of Quality Tools. Ensure inspection readiness and fulfilment of commitments to Health Authority Inspections.
- Provide expertise and leadership in coordination with GQA, to support special business needs , e.g. due diligence, contract update, resolution of a recurring quality issue.
- Implement Technical Agreements (TA) with adequate requirements with logistics partner, 3rd party customers, and other company entities as applicable.
- Investigate / assess deviations occurring during transport, packaging, storage, local testing and release of imported products, and secondary distribution. Ensure adequacy and timeliness of CAPA.
- Primary contact with Global Recall Committee. Coordinate potential recall activities with regional cluster partners, including mock recalls.
Required Experience & Competences
- At least 15 years' experience in the pharmaceutical industry within the region, in operational quality, familiar with different dosage forms, including sterile products.
- Pharmacist (preferred) or University degree in life science.
- Good Experience in Quality Assurance and Regulatory inspections.
- Experience with manufacturing and packaging sites is an asset.
- Certified Lead Auditor.
- Good command in English and writing skill, native and/or advanced Spanish is a must, Portuguese is an asset.
- Strong business mind set with demonstrated ability of conceptual and strategic thinking, drive for improvement and performance efficiency.
Residence: position to be located in one of our major markets in the region: Argentina, Brazil or Mexico.
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