345647BR
Jun 16, 2022
Netherlands

Job Description

The Novartis Quality Organization ensures that we deliver high quality, safe and effective medicines to our patients on time, every time. As part of the Quality Management System & Compliance function, the QMS & Compliance Associate role is waiting for you to make a positive impact on quality and product quality and patients lives.

Your key responsibilities:
• Ensure oversight of GxP vendors in The Netherlands and relevant QAAs are in place and timely updated.
• Ensure timely Change Control and deviation management. Ensure networking within other QMS teams in countries as well as Regional / Global key representatives.
• Ensure QA support in the PSA process.
• Ensure networking within other QMS teams in countries as well as Regional / Global key representatives with the objective to simplify and establish more effective compliant processes harmonized across the divisions in NL. Ensure that relevant SOPs are aligned to HA regulatory requirements, mainly related to GMP & GDP regulations.
• Key user / Admin for all quality tools locally implemented ESOPS, CONDOR, ViPER, AQWA, ESOPS, TW, Agile, Up4G.
• Establish regular review, assessment and reporting of KQIs and other performance metrics at the appropriate committees and forums in The Netherlands.
• Ensure that relevant SOPs are aligned to HA regulatory requirements, mainly related to GMP & GDP regulations
• Support GxP regulatory Inspections and internal audits of the Country Organization.
• Responsible for the quality systems and the operational excellence related to Training, Deviations, Change Control, CAPAs, GxP Documentation, Vendor management, Quality Risk Assessment, PQR, Audit & Inspection, QA Artworks, QA agreements, regulatory surveillance.
• Perform and maintain effective business relationship with all key suppliers. Provide input to periodic QA Governance meetings, operationally and strategic.
• Support strategic quality and business initiatives, including appropriate remediation programs, quality/compliance activities and affected changes, continuous improvement initiatives for quality and compliance related areas.
• Foster and champion a quality culture and a quality mindset. Become a key business partner with relevant business process owners.
• Conduct Self-inspections in area of responsibility and ensure an adequate self-inspection plan is in place monitored and timely executed.

Diversity & Inclusion / EEO

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Minimum Requirements

• Third-level (Diploma/Degree) qualification in Life Sciences, Pharmacy, Chemistry or Biologist, or commensurate experience;
• 3-7 years in the pharmaceutical industry;
• Experience in QA Operations, production, QC and/or other relevant operational areas;
• Thorough knowledge of cGMP requirements;
• Good knowledge of GxP related matters in area of responsibility;
• Team and consensus builder with definitive and authoritative decision-making ability;
• Fluency in English as a business language (oral and written). Dutch is an advantage;
• Organization of own workload – self-directed, able to flex to meet peaks in workload;
• Working cross functionally;
• Good working knowledge of Microsoft Excel, Word, Visio etc.

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!
Novartis Technical Operations
NTO QUALITY
Netherlands
Amsterdam
Quality
Full Time
Regular
No
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345647BR

QMS & Compliance Associate

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