QA Lead North America of External Quality, North America Hub

Novartis - Montréal, QC (il y a 6 mois)

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927 million. That’s how many lives our Novartis group products touched last year. And while we’re proud of that, 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 empowered to ask new questions, make bolder decisions and take smarter risks.

We are Sandoz, a Novartis Division. Join us and help reimagine medicine.

As the ESO QA Lead North America of External Quality, North America Hub, you will be responsi-ble for all aspects of Quality Assurance with respect to supply of Drug Products manufactured at Contract Manufacturing Organizations (CMO). You will ensure appropriate oversight, assessment and mitigation of risk to quality practices and supply, ensuring that all aspects of the relationship and the management thereof, are in compliance with cGMP and regulatory requirements, the Novartis Quality Manual, and industry practices, and for ensuring release of products to comply with US/Canada regulations and Novartis requirements.
You will lead the Quality team strategically and operationally. You will ensure a culture of em-powerment and accountability across the entire team, providing the support necessary to team members working in an “end-to end”, cross-functional organization model. You will also be re-sponsible for people management processes and actively supports the development of QA asso-ciates.

In this role, you will:
  • Manage, support and supervise a team of QA managers responsible for the oversight of operations at Third Parties and Licensees with respect to implementation and maintenance of local Quality Management Systems and with regard to provision of adequate resources and performance monitoring
  • Responsible for managing the performance and development of quality associates in the hub.
  • Provide strategic quality directions for the North America hub.
  • Maintains state-of-the-art knowledge of Health Authority requirements, trends, technologies, processes and systems.
  • Manage/support the resolution of quality and technical problems at Third Parties/Licensees consistent with global standards
  • Ensures the Quality Assurance Agreements are created and maintained according to Novartis requirements, that they are regularly reviewed and followed, and that they address the respective roles, responsibilities and requirements for all parties involved in the supply of the product.
  • Ensures all aspects of Quality Management of the External Supplier is carried out according to the standards defined, and is regularly reported and assessed for adequacy of performance
  • Determines the quality strategy and the Quality Planning for the External Supply unit and ensures that all critical issues are incorporated with clear and timely actions to address the issues
  • Implement and maintains a Quality Risk Management program that assesses the individual Quality Risk Assessments of Third Parties and the adequacy of proposed CAPA plans, mitigates unacceptable risk in conjunction with External Supply management and Novartis Quality.
  • Ensures robust review and escalation of critical quality issues arising within the area of responsibility
  • Establish and monitor Key Performance Indicators and ensure that all parts of the External Supply QA organization are working in a consistent manner against harmonized expectations. Initiate corrective actions when necessary and perform follow-up on resulting measures
  • Define and maintain the processes for managing QA activities at External Suppliers.
  • Ensure that the Head of ESO QA Americas is kept informed of all critical and major issues which may have an adverse effect on the quality of the product produced at External Suppliers.
  • Acts as a deputy for the Regional ESO QA Head.
  • Ensure that the SRTs are kept informed of all critical and major issues which may have an adverse effect on the quality of the product at an External Supplier
  • Ensure that coordinated contact is maintained with other functions within Novartis namely Legal, Regulatory CMC, Drug Regulatory Affairs and Group Quality Operations (GQO)
Minimum requirements

Higher university degree (e.g. Master. Ph.D.) in Pharmacy, Biochemistry, Chemistry, Microbiology or another related science;
Fluent in speaking / writing in English; speaking in French is an advantage;
15-20 or more years of experience in the pharmaceutical industry, with direct experi-ence with Pharmaceutical/Biopharmaceutical products;
Experience in manufacturing and packaging of non-sterile and sterile dosage forms;
Experience in QA Operations, production, QC and/or other relevant operational areas, but must include mini-mally 10-15 or more years in QA, and 10 or more years of man-agement and leadership experience;
Thorough knowledge of FDA/EMA/WHO/Canada regulations;
Strong understanding of regulatory requirements for commercial pharmaceutical or biological products;
Experience with generic products a plus;
Proven track record with FDA, EMEA, Health Canada, and other inspections;
Strong understanding of risk assessment and risk management fundamentals/tools;
Technical understanding of manufacturing/testing processes
Experience managing third party manufacturers is desired
Capable of routine domestic and occasional global travel, approximately 20-40% of time;
Strong and proven communication skills and leadership.

At Sandoz Canada, we are committed to equitable access to employment opportunities and workplace diversity.

Only candidates selected for an interview will be contacted.

Division

Novartis Technical Operations

Business Unit

NTO QUALITY

Country

Canada

Work Location

Montreal South Shore – Boucherville

Functional Area

Quality

Job Type

Full Time

Employment Type

Regular

Shift Work

No