QA Compliance Expert (m/f/d) Site Regulatory CMC

316274BR
Sep 23, 2021
Austria

Job Description

QA Compliance Expert (m/f/d) Site Regulatory CMC, Schaftenau, Tyrol, Austria

799 million. That’s how many lives our products touched in 2019. 200 projects currently in clinical development. 16 major approvals last year alone. These are achievements we’re incredibly proud of, but in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives?

We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you’re given the opportunity to explore the power and potential of data and digital. Where you’re empowered to risk failure by taking smart risks. Where you’re encouraged to share new ideas that can open up new ways of making things happen. And where you’re surrounded by teams who are equally determined to transform lives by tackling the world’s toughest medical challenges.

We are Novartis. Join us and help reimagine medicine.

Your Responsibilities:

Drive in an un-bossed way and under own initiative plus supporting on-site regulatory CMC related launch and post-approval activities (post-approval changes, transfers, remediation, divestment, pruning and due diligence) of the site specific (global and local) products to ensure timely supply to the markets in compliance with current regulatory obligations and requirements and champion experience sharing within the site.

Your responsibilities include, but are not limited to:
• Act as single point of contact and advisor for worldwide regulatory intelligence information on the site for Medical devices, drawing on extensive regulatory expertise with a focus on innovation, maximizing the business benefit balanced with regulatory risks and compliance
• Provide regulatory strategic guidance as member of local change control board. Consider current regulatory requirements and trends in order to ensure accuracy and completeness of regulatory relevant information in the change requests while including potential regulatory hurdles
• Support global CMC submission activities (reviewing, coordination, submission) for assigned projects/products, while applying the global/site strategy into submissions
• Support required documentation and any content, quality and/or timeliness issues for global submissions and negotiate the delivery of approved technical source documents in accordance with project timelines
• Review high-quality CMC documentation & Health Authorities answer documents for Health Authority submissions, establishing and applying CMC global regulatory strategies, current regulatory trends and guidelines. Ensure technical congruency and regulatory compliance, meeting agreed upon timelines
• Represent Site Reg CMC on cross-functional project teams and maintain collaborative partnerships with stakeholders
• Act proactively, providing strategic advice within and outside of RA CMC, driving continuous improvement

Minimum Requirements

What you’ll bring to the role:
• Degree in Science (e.g. Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent or advanced degree in Science (e.g. Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent
• Fluent English (oral & written) and good skills in site (local) language german (oral & written)
• 4-6 years or more experience in pharmaceutical manufacturing site and/or QA/QC or in technical development; solid know-how in pharmaceutical technology and project management experience
• 2 years or more experience in Regulatory Affairs CMC preferable

Why consider Novartis?
799 million. That’s how many lives our products touched in 2019. And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives?

We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you’re given opportunities to explore the power of digital and data. Where you’re empowered to risk failure by taking smart risks, and where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges.

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 € 51180.50 per year on a full time basis)

Imagine what you could do at Novartis!

Novartis are an equal opportunities employer and welcome applications from all suitably qualified persons.

Commitment to Diversity & Inclusion:
Novartis embraces diversity, equal opportunity and inclusion. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration, and empowers our people to unleash their full potential.

Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
Novartis Technical Operations
NTO QUALITY
Austria
Schaftenau
Quality
Full Time
Regular
No
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316274BR

QA Compliance Expert (m/f/d) Site Regulatory CMC

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