Senior Quality Assurance Manager
hace 1 semana
Company Overview
Biomat S.A. is a global healthcare company dedicated to improving the health and well-being of people around the world.
We are leaders in plasma-derived medicines and transfusion medicine, developing, producing, and marketing innovative medicines, solutions, and services in over 110 countries and regions.
About the Role
We are seeking a highly skilled Senior Manager Quality Control to lead our Quality Control area within our Biopharma division.
The successful candidate will be responsible for ensuring the quality and safety of plasma processed at our facilities, adhering to quality standards (GMP, ISO) and current legislation.
Key Responsibilities
- Lead and Organize the Quality Control Laboratory: Oversee routine operations, ensuring efficient workflow and adherence to standards.
- Participate in Analytical Investigations, CAPAs, and complaints: Evaluate analytical results, analyze incidents, and implement corrective, preventive, and improvement actions.
- Conduct Risk and Impact Analysis: Assess changes in processes, techniques, and facilities to ensure minimal risk and optimal performance.
- Review and Approve Validation Reports: Ensure analytical methods meet regulatory and quality standards.
- Manage Documentation: Propose, review, and approve documentation for the laboratory and collaborative areas.
- Supervise Training Programs: Define and oversee training for laboratory personnel, ensuring continuous professional development and regulatory compliance.
- Ensure Compliance with Quality and Safety Standards: Maintain high standards of quality and safety, ensuring cohesive and aligned work practices.
- Resource Planning and Allocation: Efficiently plan and allocate human and material resources, optimizing their use.
- Budget Management: Propose and manage budgets and investments for the laboratory.
- Lead Laboratory Projects: Oversee and guide projects related to the laboratory, ensuring successful implementation and outcomes.
Who We're Looking For
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
Salary and Benefits
The estimated salary for this position is $120,000 per year, plus benefits including medical, dental, and vision coverage, as well as a 401(k) retirement plan.
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