The Head QA Systems & Compliance is responsible for the compliance, quality assurance and development of the Quality Systems of all Sites in Kundl & Schaftenau as well as manages dedicated teams with focus on Key Quality Systems, Inspection Management, Document Management, System Super Users (Shape LIMS) and Novartis Business Services QA.
The main accountabilities are the following :
Implementation, maintenance and optimization of the existing Q-systems for deviations, OOS, CAPAs, changes, complaints, recalls, APQRs, trainings etc.
for all sites in Kundl & Schaftenau
Ensure that GOP implementation, Regulatory Compliance, Pharmacopeial Compliance are systematically set and implemented for all sites in Kundl & Schaftenau
Assure permanent quality and compliance in consideration of regulatory GMP guidelines and the internal company quality policies
Ensure QA Oversite for outsourcing activities
Ensure that GCA and HA inspection preparation, coordination, follow up are done timely and all KPIs are met
Ensure that external and supplier audits are planned with a good communication GCA and all allocated audits are done timely by certified GMP Auditors
Ensure Document Management and Learning Systems are set acc to GMP regulations and followed at all sites in Kundl & Schaftenau
Ensure QA oversight for NBS and REFS activities
Participation in self inspections, regulatory inspections and customer audits
GMP information interface to other departments as well as realization of trainings
Preparation, review or approbation of GMP relevant documents (e.g. SOPs, reports)
Reporting of quality relevant key performance indicators
Responsible for the leadership aspects of the group by ensuring the preparation of job descriptions, performance management plans and conducting employee performance reviews (including hiring, coaching / development, providing an environment that fosters teamwork and assigning responsibility and accountability at proper levels)
Education : Graduate in Natural Sciences (Chemistry, Pharmacy, Microbiology, or similar)
Experience : Minimum 10-12 years of experience in the pharmaceutical industry, ideally in QA with focus on Quality Systems, profound leadership experience
Language : Fluent in writing and speaking of English, German knowledge is a plus
Profile : Open-minded personality, people development capabilities, able to empower and motivate cross-functionally, good communication skills, enjoys challenging environment
We offer a market-competitive base salary in line with your qualification, experience and individual competencies. Additionally we offer an attractive incentive program, a modern company pension scheme, childcare facilities, learning & development options and worldwide career opportunities within the Novartis group.
The base pay is composed of a market oriented excess payment and the respective amount according to the Austrian collective agreement (at least € 90,000. per year)
Contact : Viktoria Wasle, Human Resources Manager