QA Compliance Lead: Change Control & Audit Readiness

AT33 (FCRS = AT033) Novartis Pharmaceutical Manufacturing GmbH; Schaftenau; On-site; EUR 67,000 - 105,000; Full time

Job summary

Novartis Pharmaceutical Manufacturing GmbH in Schaftenau, Austria is seeking a QA Compliance Expert (m/f/d) to strengthen change control and quality systems. You will support audits, health authority inspections, and ensure medicines meet high quality standards.

You will collaborate across teams, guide users of electronic quality management systems, drive process improvements, and support deviations, CAPAs, and regulatory submissions in an onsite, professional environment.

Qualifications

• University degree in natural sciences, chemistry, biology, or comparable field.
• 3+ years of pharma GMP experience.
• Experience with quality assurance and compliance audits.
• Fluency in English and at least medium German.

Responsibilities

• Coordinate site change control activities and lead the change review board.
• Manage customer change notifications with clarity, accuracy, and timely follow-through.
• Guide users and deliver training on electronic quality management systems.
• Support deviation reports, corrective and preventive actions, and quality event processes.
• Prepare for and support compliance audits and health authority inspections.
• Monitor key performance and quality indicators, addressing gaps and supporting compliance.
• Lead quality management projects focused on process optimization and effective quality system implementation.
• Support contractor oversight, product quality reviews, risk assessments, and regulatory submissions.

Skills

Quality Assurance

GMP knowledge

Project management

Communication

Decision making

Organizational skills

English proficiency

German proficiency

Education

University degree in natural sciences, chemistry, biology, or a comparable field

Job description

Novartis Pharmaceutical Manufacturing GmbH in Schaftenau, Austria is seeking a QA Compliance Expert (m/f/d) to strengthen change control and quality systems. You will support audits, health authority inspections, and ensure medicines meet high quality standards.

You will collaborate across teams, guide users of electronic quality management systems, drive process improvements, and support deviations, CAPAs, and regulatory submissions in an onsite, professional environment.