Responsible for managing quality aspects at external suppliers for Biopharmaceuticals / Pharmaceutical / Devices and to ensure that the operational business is in compliance with cGMP, the Quality Assurance Agreement, regulatory requirements and the Novartis Pharma Quality Manual and is conducted according to the relevant SOPs.
Act as permanent deputy of the QA Lead.
Lead External Suppliers Qualification process.
Acts as Single Point of Contact / SPOC for all quality related activities at the External Supplier
Ensure that all aspects of the handling, manufacturing and distribution of biopharmaceutical / pharmaceutical products are in compliance with the Novartis Pharma Quality Manual, the effective Quality Agreement that they meet relevant cGMP regulatory requirements and are conducted according to local SOPs.
Responsible for driving / initiating External Supplier Quality Risk assessments to be carried out for all External Suppliers. Gaps are Quality Systems to be identified with an evaluation of the associated risks. Remediation plans are to be defined and execution is to be monitored to ensure that issues are suitably addressed
Provide the quality presence and in-put to Technical meetings with the External suppliers and establish good working relationships with clear communication and defined actions and goals.
Ensure that a valid QA agreement defined in line with the requirements of the Global template is in place which clearly defines cGMP roles and responsibilities between Novartis and the External Supplier, as well as Product details and requirements. Approve Quality Agreement on behalf of the QA Lead.
Request, review and process GMP documentation as defined by the Quality Agreement and Novartis SOPs. Manage the quality aspects of the relationship in accordance with the effective Quality Agreement. Perform the required periodic review and make recommendations for amendments to the agreement based on identified needs and issues.
Responsible for coordinating and ensuring that Quality auditing of External suppliers is carried out according to the Novartis Quality Manual - maintain an annual auditing program, participate in and/or lead audits, manage action plans and follow up on agreed upon CAPAs. Ensure site readiness for regulatory inspections at External suppliers where appropriate. Manage/Approve critical quality issues (deviations, complaints, recalls, counterfeits and product tampering, stability failures, etc) according to the Quality Agreement and the Novartis Quality Manual. Ensure investigations are correctly executed. Ensure all required actions are taken appropriately and in a timely fashion.
The number and severity of cGMP issues identified during internal Global Quality Organization and Health Authority audits of External Supply QA and the External Supplier
Compliance of products according to agreed specifications
No out of stock incidents related to QA activities
Training plans in place with training conducted, assessed and documented Execution of responsibilities in a timely and efficient manner
Robustness of risk mitigation (CAPA closure effectiveness, supplier management)
Performance against established KQIs
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Bachelor or higher in Biochemistry, Chemistry, Microbiology or another related science Fluent in speaking / writing in English
15 or more years experience in the pharmaceutical industry, with direct experience with Pharmaceutical/Biopharmaceutical/API products. Experience in QA Operations, production, QC and/or other relevant operational areas, but must include minimally 5 years in QA, and 3 years of management and or project management experience.
Thorough knowledge of cGMP requirements
Strong understanding of regulatory requirements for commercial products
Proven track record with FDA, EMEA and other Health Authorities.
Strong understanding of risk assessment and risk management fundamentals/tools
Strong Technical understanding of pharmaceutical processes
Team and consensus builder, with definitive and authoritative decision making ability
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