Global QA Manager

AdQualis Human Results; Cataluña; On-site; EUR 90,000 - 120,000; Full time

Job summary

AdQualis Human Results is seeking a Global QA Manager to lead corporate quality systems, global validation and CSV, ensuring GxP compliance across all business units. You will drive continuous improvements and coordinate relevant teams to support regulatory readiness.

The role requires a Life Sciences advanced degree, 10+ years in pharma/biotech QA, and fluency in Spanish and English. Strong leadership and strategic thinking are essential to success in this global remit.

Qualifications

• Bachelor’s degree / PhD or advanced degree in Life Sciences (Pharmacy, Biology, Biotechnology, Chemistry or related).
• +10 years of experience in Quality within pharmaceutical/biotech environments.
• Fluent in Spanish and English.
• Excellent verbal and written communication, strong cross-functional leadership and strategic mindset.

Responsibilities

• Define corporate guidelines, standards and criteria for Global Quality Systems, Global Validation & Qualification, CSV and Inspection Readiness.
• Lead corporate projects to improve, harmonize, digitalize and transform GxP processes ensuring regulatory compliance.
• Drive validation and qualification strategies for facilities, equipment, processes and computerized systems.
• Engage in regulatory inspections, customer audits and certification body audits within scope.
• Collaborate with corporate and ops departments to ensure proper implementation of quality systems.
• Lead the corporate Inspection Readiness program for regulatory inspections and external audits.
• Oversee management of quality-related processes: complaints, internal audits, GLP, GDP, supplier qualification, GxP documentation, Site Master Files.
• Define and monitor KPIs across area to drive achievement of objectives.
• Lead and coordinate teams under responsibility.

Skills

Cross-functional leadership

Regulatory compliance (GxP)

Quality assurance leadership

Strategic mindset

Verbal and written communication

Education

Bachelor’s degree / PhD or advanced degree in Life Sciences

Job description

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, Global 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.