Quality Manager USA
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Job Location:
Monthly Salary:
Posted on:
8 hours ago
Vacancies:
1 Vacancy
Job Summary
The QA Manager ensures that all Quality and GMP-related activities supporting customers with operations between the United States and Latin America are executed in full compliance with the Companys Quality Management System applicable U.S. LATAM and international regulations and internal standards.
The position is responsible for coordinating and overseeing GMP-compliant services medicinal products samples and kits provided to customers with international operations between USA and LATAM ensuring regulatory compliance operational consistency and high-quality service delivery while meeting customer and regulatory expectations.
Coordinate quality oversight for customers operating between the United States and Latin America ensuring compliance for GMP services samples and kits in accordance with applicable local and international regulations.
Job Purpose
A. Quality Management & Compliance
Lead maintain and continuously improve the Quality Management System (QMS) in compliance with GMP FDA regulations (21 CFR) ISO 9001 ISO 13485 (if applicable) ICH Q10 and other relevant standards.
Act as the primary Quality and GMP compliance contact for the U.S. affiliate coordinating with global Quality teams.
Incorporate corporate Quality policies procedures and standards into the subsidiarys local QMS.
Ensure data integrity principles (ALCOA) are applied across GMP-related documentation and systems.
B. Audits & Inspections
Plan lead and execute internal audits and self-inspections.
Host and manage external audits and inspections (FDA ISO customers) in the United States including preparation execution and follow-up.
Promote cross-functional participation in audits inspections and Health Authority visits.
C. Quality Operations
Manage non-conformances deviations investigations root cause analysis and CAPA programs.
Oversee document control training management change control batch record review and quality records retention.
Ensure calibration and preventive maintenance programs are implemented documented and maintained.
Ensure correct implementation of procedures related to product recalls complaints and market actions.
D. Training & Awareness
Ensure that employees within supported subsidiaries receive appropriate and documented training on:
Company procedures
GMP requirements
Local U.S. and international regulations
Verify training effectiveness and compliance with regulatory expectations.
E. Supply Chain Distribution & Security
Ensure the correct distribution of medicines samples and kits the legitimacy of their origin and compliance with GDP and cross-border distribution requirements between USA and LATAM.
Ensure the existence and maintenance of an appropriate Business Continuity Plan.
Implement and maintain the Security Management System at the subsidiary level in coordination with global teams and approved vendors.
F. Customer & Cross-Functional Coordination
Coordinate quality oversight for customers operating between the United States and Latin America ensuring compliance for GMP services samples and kits in accordance with applicable local and international regulations.
Collaborate closely with Operations Distribution Purchasing Finance and other cross-functional teams to address quality issues and ensure compliant service execution.
G. Reporting & Continuous Improvement
Monitor quality performance and provide KPIs metrics and quality reports to senior management.
Stay current with evolving U.S. LATAM and international legislation and ensure its timely application.
Qualifications & Skills Required:
Education:
Bachelors degree in Life Sciences Engineering or related field (required).
Masters degree or certifications (e.g. ASQ CQE Lean Six Sigma) preferred.
Experience:
5 years in Quality Assurance or Quality Systems.
Experience with GMP ISO 9001/13485 FDA or ICH Q10 regulatory frameworks.
Familiarity with quality tools (e.g. CAPA Risk Management Audit software LIMS QMS platforms like
Experience supporting international operations or cross-border supply chains preferably between USA and LATAM. BV1.1
Skills:
Excellent communication and leadership skills.
Strong analytical and problem-solving abilities.
Proficient in Microsoft Office and quality management systems. List of all requirements skills needed for the role including education level and previous experience time.
Work Setting
May require occasional travel (<10%) for audits or supplier visits.
Office-based with occasional time Home Office.
Direct Reports
Quality Regional Manager EMEA/USA/APAC
Key Skills
- APQP
- Quality Assurance
- ISO 9001
- Lean Six Sigma
- PPAP
- Root cause Analysis
- ISO 13485
- Quality Systems
- Quality Control
- Quality Management
- As9100
- Manufacturing
