R&D Quality Lead

Novartis; Schweiz; Vor Ort; EUR 78.000 - 158.000; Vollzeit

Zusammenfassung

Novartis in Schaftenau, Austria, seeks a QA leader to provide quality assurance and regulatory oversight across development and research functions onsite. You will drive QMS activities, risk-based processes, and ensure compliance with GCP, GLP, GMP, PV, and IP, promoting a culture of quality and continuous improvement.

The role involves leading QA teams, coordinating with NIBR, GDD, and cross-functional partners, and ensuring timely corrective actions and inspection readiness.

Qualifikationen

• Proven ability to ensure compliance with quality system requirements and GxP processes.
• Experience leading QA teams or projects and collaborating with multiple quality groups.
• Strong ability to translate QA strategy into operational activities.
• Experience with health authority inspections and CAPA programs.

Aufgaben

• Provide QA expertise to ensure quality system compliance and GxP processes.
• Lead QA organization or project teams and collaborate with partners and other quality groups.
• Translate QA strategy into applicable operational activities and risk-based implementations.
• Address quality and compliance gaps with process improvements and training.
• Monitor Quality Plan implementation and support inspection readiness activities.
• Oversee external service providers and IT systems for R&D and drive audits/inspections follow-up.
• Ensure timely deviation/incidence escalation and robust investigations.
• Contribute to lessons learned from audits, inspections, incidents, and metrics.
• Report technical complaints or adverse events within required timelines.

Kenntnisse

Quality Assurance

GxP Experience

Audit & Inspection Management

People Management

Regulatory Compliance

Quality Management Systems

Jobbeschreibung

Salary Range:

€85,300.00 - €158,300.00

Job Description Summary

Location: Schaftenau, Austria #onsite

Role Purpose

Provide quality assurance and compliance oversight to development and research functions. Drive the oversight of quality management systems and initiatives within the global, regional, and country organization, ensuring compliance with applicable health authority regulatory requirements (e.g., GCP, GLP, GMP, PV, IP) and Novartis procedures and quality standards. Role model good quality behaviors while promoting a culture of quality (e.g., right first time, etc.) to positively impact the non-quality stakeholders (e.g., NIBR, GDD). Develop, drive and/or support Quality plan initiatives in order to achieve organizational strategy, mission and vision.

Job Description

Major Accountabilities:

• Provide QA expertise and guidance to ensure compliance with requirement of the quality system are met, including implementation of quality risk-based and GxP relevant process.
• Lead and manage a QA organization and/or quality project team and collaborate with business partners and other quality groups to ensure health authority and regulatory requirements are fully met
• Translate functional QA strategy into applicable operational/compliance activities and support a risk -based implementation and execution of processes.
• Ensure quality and compliance gaps are addressed and executed for sustainability and implement strategic process improvement, including review of procedural updates, training, process improvement, effectiveness checks, etc.
• Monitor implementation of the Quality Plan and support inspection readiness activities, including participation in regulatory inspection preparation, management and follow-up.
• Support quality oversight/management of external service providers and IT systems supporting research and development activities and drive facilitation and follow -up of audits and inspections, and ensure development, implementation and completion of appropriate corrective and preventive measures for findings
• Ensure timely escalation of deviation/incidents and provide quality oversight for deviations/incidents, including robust investigations, root cause analysis and corrective actions implementation.
• Contribute towards lessons learned based on audits, inspections, incidents, regulatory intelligence, effectiveness checks on process implementations and metrics and support a culture of proactive, risk -based behaviour
• Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt
• Distribution of marketing samples (where applicable)

Key Performance Indicators:

• Quality and timelines of strategic project documentation and presentations: Documentation available on time and of high quality
• Reliable, timely and accurate information/communication about project specific issues and to key stake holders.
• Deliver on departments cost/budget-Establish succession plan
• Role Model of Novartis culture, values, & behaviours

Work Experience

• Audit & Inspection Management
• Quality Management Systems
• Quality Assurance
• GxP Experience
• Good Manufacturing Practices (cGMP)
• People Management
• Quality Compliance
• Drug Development
• Research
• Technological Expertise
• Complaints Management
• Good Laboratory Practice (GLP) Analytics
• Incident Management
• Deviation Management
• Patient Safety
• Pharmacovigilance

Languages

English.

Salary Disclosure

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 €78,383.90/year (on a full time basis). The actual salary will be significantly higher, as we strive to maintain a competitive position in the market and consider your previous experience, qualifications and individual competencies

Adjustments for Applicants with Disabilities

Adjustments for Applicants with Disabilities: If because of a medical condition, physical disability or a neurodiverse condition you require an adjustment during the recruitment process, please reach out to [e-mail] and let us know the nature of your request as well as your contact information. The support which we can provide will include advice on suitable positions as well as guidance at all stages of the application process. Austrian law provides candidates the opportunity to involve the local disability representative, Behindertenvertrauensperson (BVP), in the application process. If you would like to request this, please let us know in advance as a note on your CV.

Skills Desired