QA Lead, Product Surveillance — Proactive Quality

Cytiva; Uppsala kommun; Vor Ort; SEK 650.000 - 900.000; Vollzeit

Zusammenfassung

Cytiva in Uppsala is seeking a QA Lead – Product Surveillance to own the complaint and field action processes with high visibility across the organization. You will drive proactive, data-driven complaint management and ensure robust regulatory compliance in a highly regulated environment.

As part of the QA team, you will lead cross-functional collaboration, coordinate during critical field actions, and shape the global approach to complaint handling, CAPA, and improvement funnels, ultimately

Qualifikationen

• Experience from complaint handling or similar quality processes within life sciences
• Experience working in an ISO9001/13485 and/or cGMP environment
• Strong analytical and communication skills
• Fluency in Swedish and English, both written and verbal

Aufgaben

• Own and continuously develop the complaint, field action, product hold, and improvement funnel processes at site level
• Drive the transformation towards a more proactive, data-driven complaint management approach
• Lead and coordinate cross-functional teams within the Complaint Handling Unit (without formal line management)
• Act as Subject Matter Expert and key contact in audits and customer interactions
• Ensure effective complaint handling, including investigation, documentation, and customer communication
• Analyze trends and present insights to operational and management reviews
• Approve CAPA/EC plans, impact assessments, and ensure robust closure decisions
• Play a key role in implementing a new global complaint process (goes live Q4)

Kenntnisse

Analytical skills

Communication skills

Leadership by influence

Swedish language

English language

Ausbildung

Bachelor’s degree or high school diploma

Tools

Microsoft Excel

Jobbeschreibung

Cytiva in Uppsala is seeking a QA Lead – Product Surveillance to own the complaint and field action processes with high visibility across the organization. You will drive proactive, data-driven complaint management and ensure robust regulatory compliance in a highly regulated environment.

As part of the QA team, you will lead cross-functional collaboration, coordinate during critical field actions, and shape the global approach to complaint handling, CAPA, and improvement funnels, ultimately