Quality Assurance Operations Lead

About the role

The Quality Assurance Operations Lead is based in La Almunia de Doña Godina, Spain, and ensures that sterile injectable products are released to the highest standards of quality, compliance and patient safety. The role oversees product release against the Quality System, current registrations, GMP, EMA, AEMPS and the Novartis Quality Manual, and leads the people, processes and technical resources of the Quality Assurance Operations department. Relocation support is not offered.

Key responsibilities

• Lead implementation and continuous improvement of compliance with GMP, AEMPS, EMA, the Novartis Quality Manual and site procedures, promoting a strong quality culture.
• Oversee QA operations: product release, documentation management, SOP approvals, training, resource planning, shift organisation for QPs and QA Officers and team development.
• Ensure quality oversight of manufacturing, maintenance, qualification, calibration, revalidation, process validation, cleaning validation, equipment qualification and new projects needing QA support.
• Manage and approve quality processes such as OOS, OOT, OOE, deviations, change controls, CAPA, complaints, recalls, returns and investigations under cGMP and SOPs.
• Escalate and communicate quality and cGMP issues, non-conformities and product-impacting incidents to internal stakeholders and competent authorities when required.
• Support audits, inspections and quality reviews, including annual self-inspection, training planning and the Annual Product Quality Review.
• Monitor quality performance indicators, ensure timely delivery of projects and support business continuity with Site Management, Quality, Quality Control and Production.
• Provide QA support to commercial operations while meeting environmental, safety, order, cleanliness and communication requirements.

Required profile

• Scientific degree in Pharmacy, Chemistry or Biology.
• 5+ years of experience in the pharmaceutical industry with strong knowledge of QA operations and quality requirements.
• Fluent Spanish and English, written and spoken.
• Desirable: previous experience as a certified Qualified Person.

Required skills

• Strong understanding of cGMP regulations and pharmaceutical quality standards.
• Solid knowledge of aseptic processes and aseptic manufacturing practices.
• Excellent organisational skills, attention to detail and teamwork.

What we offer

• Expected annual base salary of EUR 45,100 to 83,700, depending on skills, competencies and experience.
• Possible performance-based bonus.
• Insurance plans, retirement plans, wellbeing resources and global recognition programmes.
• Flexible and hybrid working where possible, and at least 14 weeks of paid parental leave.