Beschreibung:For one of our Swiss Pharma clients we are seeking temporary support as:Supply Quality Manager (M/F/*)
This position has responsibility for Quality Assurance, and support of Quality Control, for external Oncology and Small Molecule Contract Manufacturing Organisations (CMOs), Suppliers, and Contract Testing Laboratories (CTLs) located within the European region, inclusive of Drug Product, QC testing, packaging, and labelling activities
The Supply Quality Manager is responsible for the Quality oversight of a portfolio of Contract Manufactures and associated products. The position requires interaction with numerous functions within the Oncology & External Supply Small Molecule (OncESSM) Operating Unit, and other External Supply regions, with manufacturing sites, Local Operating Companies (LOCs), and external partners
Responsible for the product quality performance at designated CMOs/ Suppliers, to ensure compliance and quality risks are identified, communicated and mitigated, and are an integral part of business decisions consistent with relevant standards/ cGMP and Global Quality Standards
Responsible for the preparation, approval and maintenance of Quality Agreements with relevant CMOs/ Suppliers
Responsible for product quality performance through product and supplier Quality Risk Management, deviation/ investigation review, change management, APQR evaluation, Key Performance Indicators (KPI) and other Quality processes and tools as required
Support and champion the implementation of compliance strategies, quality plans and Quality Assurance programmes for the management of outsourced product manufacturing/ packaging operations to assure the quality and compliance
Responsible for complying with the requirements of the Quality Incident Management process for relevant CMO/ Supplier manufactured products. Prepares and issues notifications and prepares for Quality Alignment Meetings in collaboration with the ESQL and/or Site Quality Head, and other stakeholders.
Establish quality and compliance expectations for CMOs/ Suppliers and support as needed CTLs; performing strategic systems reviews and coordinate risk/benefit analyses of supplier processes and systems to assure compliance with relevant standards/ cGMP and Quality System expectations.
As necessary work with specific LOCs to assure compliance with country-specific requirements/regulations for the manufacturing/ packaging of product for represented markets
Support and/or lead audits of CMOs/ Suppliers and CTLs, including preparation of audit reports and review of the acceptability of CMO/CTL corrective actions
Provide oversight in the assessment of changes or deviations for products, to assure compliance to market/ regulatory commitments, assessment and evaluation of risks, support appropriate disposition of product, and correction or improvement of operations to minimise future risks
Maintain awareness of relevant legislation and regulatory guidelines, and assure that QA supplier management programmes, systems and controls, are reviewed and updated as needed to assure compliance. As necessary, confirm requirements and regulations of other markets in support of manufacturing, testing and packaging activities
Support successful and timely completion of all product submissions, launches and new initiatives, as well as at contract manufacturing, packaging and labelling operations
Assist with audits and inspections of Oncology & External Supply Small Molecule, other facilities, and third-party suppliers associated with commercial product supply