QUALITY SYSTEM OWNER BATCH RELEASE MANAGEMENT – TEAM LEAD

Summary The Quality System Owner Batch Release Management Team Lead manages, drives and maintains initiatives and strategy for Batch Release Management Quality System across Novartis, ensuring alignment and collaboration with all functions involved in batch release activities.
Maintains knowledge with current industry trends, Health Authority expectations and influences standards accordingly to enable them to be incorporated into business processes and maintain the compliance of the Product Release and APQR Quality System.
Manages Quality Assurance activities and Projects related to batch release management quality system to ensure that all aspects of the operational business comply with cGMP legal and regulatory requirements and the Novartis Quality Manual and Policies.
About the Role Deadline for applications.
14th of April .
Major accountabilities.
Act as Quality System Owner for Product Release (including annual product quality review process), ensuring the objectives and strategy for batch management meet the expectations of Novartis and external regulatory bodies.
Drive Harmonization and Standardization for batch management across Novartis.
As QSO (Quality System Owner) for Batch Release Management, accountable for the development and implementation of an effective and efficient end-to-end Quality System.
Drives simplification and harmonization through cross-functional collaboration.
Manage and perform review of relevant Quality Manual documents for batch management and APQR, ensuring alignment with the approved quality system strategy and ensures GxP procedures & processes for the quality system are up to date, robust, aligned, and fit for purpose.
Drive and support projects associated with and impacting Batch Management, to ensure the final process, tool and/or system is fit for purpose and provides an effective and efficient means to perform batch release within the specified function and Novartis as a whole.
Ensure issues are resolved and in compliance with regulatory requirements and Novartis expectations.
Ensure that operationally, proposals can be implemented within MSO Platforms, NCQ and other functions as necessary, to support other areas such as QA Agreements, APQRs, Artwork process, Retesting Centers, Quality control activities, Change control, etc., as well as batch release.
Ensure systems to support Batch Management, such as SAP/ERP, operate as required and provide the necessary level of control needed for compliance purposes and meet the needs of the business, incorporating continuous improvement, utilizing new digital and data technologies where identified.
Manage and organize the Qualified Person Forum and the Joint Batch Release Forum for Novartis Technical Operations, Technical Research and Development and Novartis Country Quality Qualified Person, to allow sharing of best practice, review of new guidelines, as well as discuss and propose solution of issues/challenges faced by the QPs.
Provide QA support to the owner of the Safety Label Change process, providing guidance and input on the process, improvements and its performance.
Establish strong partnership with key stakeholders.
Collaborate with cross-functional teams to identify areas for improvement and recommend actionable solutions and support cross functional teams by providing provide global insight and guidance for APQR and Batch Release process.
Attend appropriate QMS Leadership Team meetings and governance boards to ensure alignment and gaining of synergies across the different QMS activities.
Maintain current knowledge of local and international regulatory and legislative requirements and trends and of Novartis business processes.
Minimum Requirements.
Education.
Degree in Pharmacy, Chemistry, Biology, or related subject; additional knowledge in Quality Assurance and Compliance At least 5 years’ experience in the pharmaceutical industry, e.
.
in Production/Technical Operations and/or Quality Assurance.
A minimum at least 2 years in Quality Assurance English fluent in speaking and writing, second language desirable.
Strong Quality Assurance and QMS understanding Project management and analytical skills.
Excellent interpersonal skills, including leadership, organizational, analytical, intercultural communication, and negotiation.
Team player.
Experience in an international matrix organization Thorough knowledge of cGMP requirements.
Strong understanding of regulatory requirements for commercial biological and pharmaceutical products Strong understanding of risk assessment and risk management fundamentals/tools.