Global Quality Platform Head RLT (remote)

Job Description Summary

At Advanced Accelerator Applications, a Novartis Company, we are committed to leading innovation in nuclear medicine and delivering the next generation of targeted radioligand therapy to cancer patients. We are looking for an experienced Quality Leader to help us reach our ambitious goals.

As the Global Quality Platform Head for Radioligand Therapies (RLT), you will be responsible for ensuring Quality oversight for the RLT platform and have ownership of budget, headcount and reporting lines. You will be a member of the Novartis Technical Operations Quality Leadership Team (TQLT) and the RLT Platform Leadership Team.

 

Job Description

Key responsibilities:

• Ensure implementation and maintenance of quality systems, policies and procedures within the Platform or with external suppliers as well as ensure oversight and control of external suppliers related to Active Pharmaceutical Ingredient, excipients and packaging materials and a timely escalation and effective communication in order to raise quality issues to the appropriate levels of management.
• Assure sites implement a coherent Quality governance structure, including a site quality review board, a defined escalation process and quality planning.
• Ensure readiness for regulatory inspections and assure sites / regions implement a coherent Quality governance structure, including a site quality review board, a defined escalation process and quality planning.
• Improve metrics and KPI analysis to drive quality performance and drive best practice sharing across the network.  Support the implementation of new technologies and innovation including global solutions and new analytical technologies to support the Novartis Technical Operations (NTO) strategy.
• Assure sites / suppliers are improving their product performance understanding through knowledge management and continuous improvement (e.g. APR/PQR system and process capability) and drive improvement of quality standards through implementation of new Quality Modules, site quality risk assessments, regulatory compliance and quality system reviews.
• Serve as main point of contact for the wider Novartis network for queries relating to Platform Quality and ensure that the Quality culture at the sites is implemented (through the Site Quality Heads).  Lead the Quality section of the Platform monthly management meeting.
• Support, advise and give guidance Site Quality Heads and Suppliers directly or through the Regional Heads in relation to GMP and regulatory matters and in issue resolution.  Escalate significant cGMP or regulatory issues to the Global Head NTO Quality and represent the Platform at the NTO Quality Leadership Council (TQLC).  Follow up with Platform sites to assure the timely closure of corrective actions resulting from health authority inspections and corporate audits.
• Develop annual Site Quality Plans in cooperation with Network Sites based on inputs from Novartis and NTO Quality Plans and support product launches and PAI readiness at the Network sites.

Essential Requirements:

• Bachelor’s degree Chemistry, Biology, Pharmacy, Biotechnology, Biomedical Engineering, or related degree.
• 15+ years’ experience in Quality Control, Quality Assurance, Quality Systems, Quality / Regulatory Compliance, Operational GxP area(s) (Manufacturing / Development), Supplier Quality and / or Post Market Quality within the pharmaceutical industry including prior experience with aseptic manufacturing.
• 5+ years’ experience leading and developing people including experience leading leaders in a global, matrix organization.
• Must have a working knowledge of FDA and ex-USA regulatory requirements as well as industry quality management tools, standard, and quality systems. Understanding of United States Pharmacopeia (USP), European Pharmacopeia (EP), American Chemical Society (ACS).
• In-depth knowledge of cGMP, applicable FDA Regulations (e.g., 21 CFR 4, 7, 11, 210, 211, 212), ICH Guidelines, EU Pharmaceutical Regulations and Directives, ISO Standards, etc.
• Prior experience with Health Authority Audits and Inspections.

Desirable Requirements:

•  Prior experience in Radioligand Therapy is preferred.

This position can be based remotely anywhere in the U.S. (there may be some restrictions based on legal entity). Please note that this role would not provide relocation as a result. The expectation of working hours and travel (domestic and/or international) will be defined by the hiring manager. This position will require 25% travel.

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