16 oct
|
Adqualis Human Results
|
Cataluña
16 oct
Adqualis Human Results
Cataluña
Pharmaceutical company looking for a Global QA Manager responsible for leading the corporate activities of Global Quality Systems, Global Validation, and CSV, ensuring the consistent implementation of quality standards, GxP regulatory compliance, and the continuous improvement of corporate Quality Assurance processes across all business units.
Key Responsibilities
- Define corporate guidelines, standards, and criteria applicable to the areas under their responsibility.
- Manage corporate projects related to Global Quality Systems, General Validation & Qualification, CSV, and Inspection Readiness, including improvement, harmonization, digitalization, and transformation initiatives impacting GxP processes, ensuring their proper implementation and regulatory compliance.
- Lead corporate validation and qualification strategies for facilities, equipment, processes, computerized systems, analytical methods, environmental monitoring programs, and other related areas.
- Participate in regulatory inspections, customer audits, and certification body audits within their scope of responsibility.
- Collaborate with corporate and operational departments to ensure the proper implementation and effective functioning of quality systems and processes.
- Lead the corporate Inspection Readiness program, ensuring the preparedness and alignment of different departments for regulatory inspections and external audits.
- Oversee the effective management of corporate processes related to quality complaints, internal audits, GLP, GDP, supplier qualification, GxP documentation, and Site Master Files.
- Define and monitor key performance indicators (KPIs) within their area of responsibility, driving the necessary actions to ensure achievement of established objectives.
- Lead and coordinate the teams under their responsibility.
Profile Requirements
- Bachelor’s degree / PhD or an advanced degree in Life Sciences, such as Pharmacy, Biology, Biotechnology, Chemistry, or a related field.
- + 10 years of experience in Quality within pharmaceutical or biotechnology environments.
- Fluent in Spanish and English.
- Excellent verbal and written communication skills, combined with strong cross-functional leadership and a strategic, results-oriented mindset.
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📌 Global qa manager (Cataluña)
🏢 Adqualis Human Results
📍 Cataluña