Quality Manager Remote Austria (m/f/d), Schaftenau, Tyrol, Austria
857! That is the number of third party stakeholders and diverse materials that you will ensure remain both compliant and qualified. At the same time, you will work to onboard new third parties while on the frontline of new technologies used in Technical Development at Novartis. You will also have the opportunity to work within a global team and support the global TRD organization to ensure that our development teams have access to the latest technology in order to support our clinical trials with the ultimate aim of reimagining medicine.
Your key responsibilities:
Your responsibilities include, but are not limited to:
• Responsible for the evaluation of the compliance status, approval and oversight of Third Parties used in global TRD (e.g. monitoring of Third party Assessment due dates)
• Assist outsourcing projects in global Third Party QA role from onboarding through entire live cycle with impact on the global TRD outsourcing strategy
• Assist key initiatives in the global TRD Third Party Management work stream (e.g. Third Party Quality Risk Assessments, chair global meetings, improvement projects and establishment of new processes)
• Manage establishment and final signature of Quality Agreements with Third Parties in alignment with the TA, audit reports, and applicable Novartis SOPs and standards as well as Health Authority requirements
• Manage the creation and maintenance of SOPs and related documents and sets standards for global QA Third Party management (e.g. SOPs and QA Agreement templates) as per Novartis standards and Health Authority requirements
• Responsible for the execution of risk assessments and performance tracking of Third Parties to allow continuous monitoring and early detection of negative trends, proposing remediation actions and escalating as required
• Support maintenance of the regulatory-required files for health authority inspections and assist with health authority inspection management
• Support initiatives focused on quality, process and compliance improvement, including identification of opportunities and develop strategies aimed at improving quality while ensuring compliance with regulatory requirements
Diversity & Inclusion / EEO
Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
What you'll bring to the role:
• BSc or MSc in a relevant field (Pharmaceutics, Biology, Chemistry, etc.)
• Experience in the pharmaceutical industry
• Fluency in English
• Ability to work independently with the possibility to work full-time from home based in Austria
• Good knowledge of cGMP, working knowledge in technical development, production or Quality Assurance
• Sound scientific, technical and regulatory knowledge
• Good organizational and decision-making skills
• Proven ability to analyze and evaluate cGMP compliance
• Proficiency in German
766 million lives were touched by Novartis medicines in 2021, and while we're proud of this, we know there is so much more we could do to help improve and extend people's lives.
We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.
We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world's toughest medical challenges. Because the greatest risk in life, is the risk of never trying!
Imagine what you could do here at Novartis!
In addition to a market-competitive base salary, we offer an attractive incentive program, a modern company pension scheme, childcare facilities, learning and development options as well as worldwide career opportunities within the Novartis group. 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 €54,788.30 per 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 & Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse team's representative of the patients and communities we serve. Our recruitment decisions are based on selecting the best person for the job, regardless of gender, religion, age, colour, race, sexual orientation, nationality or disability.
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network