Senior QA Operations Lead - GMP Compliance & Release

Novartis AG; Zaragoza; Hybrid; EUR 45,000 - 84,000; Full time

Benefits offered by this job

Insurance plans

Retirement plans

Wellbeing resources

Global recognition programs

Hybrid working options

14 weeks paid parental leave

Job summary

Novartis AG on-site in Zaragoza leads QA Operations to ensure aseptic product releases, documentation, and continuous quality improvement. The role governs deviations, CAPA, investigations, and change controls while maintaining strict GMP, EMA, and AEMPS compliance across site operations.

The position oversees QA support for manufacturing, training, resource planning, and timely escalation of quality issues, fostering a strong quality culture and readiness for inspections.

Qualifications

• Degree in Pharmacy, Chemistry or Biology with QA exposure.
• 5+ years in the pharmaceutical industry with QA operations experience.
• Strong knowledge of cGMP regulations and aseptic processes.
• Fluent in Spanish and English.

Responsibilities

• Lead QA Operations activities including product release and documentation management.
• Oversee deviations, CAPA, investigations and change controls.
• Ensure compliance with GMP, EMA, AEMPS and site quality procedures.
• Support audits, inspections, and annual Product Quality Review.

Skills

QA Operations

cGMP

Regulatory Compliance

Quality Culture

Leadership

Education

Pharmacy

Chemistry

Biology

Job description

Novartis AG on-site in Zaragoza leads QA Operations to ensure aseptic product releases, documentation, and continuous quality improvement. The role governs deviations, CAPA, investigations, and change controls while maintaining strict GMP, EMA, and AEMPS compliance across site operations.

The position oversees QA support for manufacturing, training, resource planning, and timely escalation of quality issues, fostering a strong quality culture and readiness for inspections.