Job Description Summary #LI-Hybrid
Location: Schaftenau, Austria
The Qualified Person (QP / Sachkundige Person) is responsible for the final certification and release of medicinal products in accordance with § 7 of the Arzneimittelbetriebsordnung (AMBO 2009). Based in Austria, you will ensure that every batch is manufactured and tested in full compliance with the Austrian Medicines Act (AMG), the Marketing Authorization, and current GMP requirements. With clear legal accountability, you will verify product quality and documentation to ensure no batch is released—whether for the Austrian market or for export—without confirmed compliance.
Job Description Key responsibilities
Technical Release and Market Release (Certification) of secondary packed drug product batches (FDF batches) for commercial purposes.
Tasks of a Qualified Person in accordance to the “Arzneimittelbetriebsordnung (AMBO) 2009” and Annex 16 to Volume 4 of the EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human Use.
Lead and oversee
critical negotiations
with internal and external stakeholders to secure compliant, timely outcomes.
Provide
people leadership
(coaching, performance management, capability building) to drive a strong quality culture.
Manage
technical operations execution , ensuring effective day‑to‑day quality support and issue resolution.
Collaborate across functions and boundaries
to align on priorities, risks, and delivery commitments.
Participation in escalations, recalls, critical complaint investigations, deviations, evaluation of process changes.
Plan and deliver projects
to agreed quality, scope, and timelines; ensure readiness for key milestones.
Ensure
inspection and audit readiness ; coordinate responses and drive timely, sustainable CAPAs. Support preparation of and participation in audits and inspections.
Maintain and improve
Quality Management System
processes to meet cGMP and GxP requirements.
Oversee
release management
activities to ensure compliant disposition decisions and documentation quality.
Report
technical complaints, adverse events, and special case scenarios
related to Novartis products within
24 hours
of receipt.
Coordinate
distribution of marketing samples
(where applicable) in accordance with applicable procedures and compliance standards.
Essential Requirements
Proven experience in
Audit and Inspection Management , including inspection readiness and follow-up actions.
Strong working knowledge of
cGMP
and broader
GxP
requirements within a regulated environment resulting in strong decision making skills.
Hands‑on experience with
Release Management
and compliant batch disposition processes.
Solid expertise in
Quality Management Systems (QMS) ,
Quality Assurance , and
Quality Compliance .
Background in
Technical Operations
with strong
technological aptitude
and a focus on continuous improvement.
Demonstrated
people leadership
capability with sound
decision‑making
(correctly interprets analyses and evaluations and correctly identifies which measures should be taken) in a patient‑focused environment.
Strong
collaboration, communication, problem‑solving , and ability to
navigate ambiguity
effectively.
High commitment to
data integrity
and
digital proficiency ;
fluent English
required.
Benefits & Rewards In accordance with Austrian law, we are obliged to disclose the minimum salary as stated in the collective bargaining agreement. For this position the minimum salary is € 73,122.90 /year (on a full‑time basis). In most cases, the actual salary will be higher, as we strive to maintain a competitive position in the market and consider your previous experience, qualifications, and individual competencies.
Commitment to Diversity and Inclusion Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Skills Desired
Collaboration
Communication Skills
Data Integrity
Dealing With Ambiguity
Decision Making
Digital saviness
Leadership
Problem Solving Skills
Regulatory Requirements knowledge
#J-18808-Ljbffr
Location: Schaftenau, Austria
The Qualified Person (QP / Sachkundige Person) is responsible for the final certification and release of medicinal products in accordance with § 7 of the Arzneimittelbetriebsordnung (AMBO 2009). Based in Austria, you will ensure that every batch is manufactured and tested in full compliance with the Austrian Medicines Act (AMG), the Marketing Authorization, and current GMP requirements. With clear legal accountability, you will verify product quality and documentation to ensure no batch is released—whether for the Austrian market or for export—without confirmed compliance.
Job Description Key responsibilities
Technical Release and Market Release (Certification) of secondary packed drug product batches (FDF batches) for commercial purposes.
Tasks of a Qualified Person in accordance to the “Arzneimittelbetriebsordnung (AMBO) 2009” and Annex 16 to Volume 4 of the EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human Use.
Lead and oversee
critical negotiations
with internal and external stakeholders to secure compliant, timely outcomes.
Provide
people leadership
(coaching, performance management, capability building) to drive a strong quality culture.
Manage
technical operations execution , ensuring effective day‑to‑day quality support and issue resolution.
Collaborate across functions and boundaries
to align on priorities, risks, and delivery commitments.
Participation in escalations, recalls, critical complaint investigations, deviations, evaluation of process changes.
Plan and deliver projects
to agreed quality, scope, and timelines; ensure readiness for key milestones.
Ensure
inspection and audit readiness ; coordinate responses and drive timely, sustainable CAPAs. Support preparation of and participation in audits and inspections.
Maintain and improve
Quality Management System
processes to meet cGMP and GxP requirements.
Oversee
release management
activities to ensure compliant disposition decisions and documentation quality.
Report
technical complaints, adverse events, and special case scenarios
related to Novartis products within
24 hours
of receipt.
Coordinate
distribution of marketing samples
(where applicable) in accordance with applicable procedures and compliance standards.
Essential Requirements
Proven experience in
Audit and Inspection Management , including inspection readiness and follow-up actions.
Strong working knowledge of
cGMP
and broader
GxP
requirements within a regulated environment resulting in strong decision making skills.
Hands‑on experience with
Release Management
and compliant batch disposition processes.
Solid expertise in
Quality Management Systems (QMS) ,
Quality Assurance , and
Quality Compliance .
Background in
Technical Operations
with strong
technological aptitude
and a focus on continuous improvement.
Demonstrated
people leadership
capability with sound
decision‑making
(correctly interprets analyses and evaluations and correctly identifies which measures should be taken) in a patient‑focused environment.
Strong
collaboration, communication, problem‑solving , and ability to
navigate ambiguity
effectively.
High commitment to
data integrity
and
digital proficiency ;
fluent English
required.
Benefits & Rewards In accordance with Austrian law, we are obliged to disclose the minimum salary as stated in the collective bargaining agreement. For this position the minimum salary is € 73,122.90 /year (on a full‑time basis). In most cases, the actual salary will be higher, as we strive to maintain a competitive position in the market and consider your previous experience, qualifications, and individual competencies.
Commitment to Diversity and Inclusion Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Skills Desired
Collaboration
Communication Skills
Data Integrity
Dealing With Ambiguity
Decision Making
Digital saviness
Leadership
Problem Solving Skills
Regulatory Requirements knowledge
#J-18808-Ljbffr
