Senior Quality Manager

Job description

Job Description

Quality Compliance and eCompliance oversight of all Quality Control related activities at a biopharmaceutical manufacturing and testing site in Basel . The position includes in addition a part-time Data-Integrity role. Manage projects and/or processes and allocated resources to support departmental projects and objectives according to agreed timelines and standards and assure compliance with GMP is maintained in Biologics Technical Development and Manufacturing Biologics Drug Substance Supply (BDSS).
• Manage portfolio of projects, support a discipline and/or provide a service on his/her own or with a team of associates. May provide functional expertise in area of responsibility (e.g. equipment qualification, single use systems…).
• Ensure Quality Assurance oversight on several activities (e.g. production, transport…)
• Lead the Quality Assurance aspects of the Biologics Technical Development and Manufacturing BDSS Commercial project.
• Review and approve deliverables (e.g. procedures, records, third party work, contractors, clinical trial material, components) and related tools (e.g. IT, document systems, training tools, facility validation) to ensure GMP compliance.
• Represent Biologics Technical Development and Manufacturing Technical Development Quality in initiatives. Liaise with key stakeholders across Pharma (e.g. Head Compliance and Inspection Management, Global Pharma Engineering) to identify compliance standardization needs.
• Supervise 0-5 indirect reports or a team and coach Quality Managers.
• Lead project related activities (e.g. development of new tools and processes).
• Write, review and approve documents (e.g. procedures, records, SOPs) and related tools (e.g. IT, document systems, training tools, facility validation) to ensure GMP compliance
• Perform inspections and audits as required
• Contribute to the evaluation of new Quality Assurance tools.
• Provide support to Technical Research and Development line functions in GMP compliance related issues in area of expertise (e.g. Transmissible spongiform encephalopathies , challenge agents, Computer System Validation).
• Coach and develop people; participate in recruitment of talent. Support a culture of high performance and trust. Assure that the required level of knowledge and skills is available and identify competency gaps. Establish and implement training and development plans.
• Meet internal and external guidelines regarding quality and safety (quality manuals, regulatory cGMP guidelines, health authority guidance's, SOPs, HSE, etc). Promote and enforce compliance to guidelines. If managing associates, ensure same for them.
• Support project management functions as a sub-team member or in preparation for a Pre-approval inspection.
• Write/contribute to internal compliance policy and/or comment to regulations.
• Lead and support direct reports in line with Novartis values and behavior including objectives setting, performance evaluations, development planning and participate in recruiting process.

Desired profile

Minimum requirements

o Minimum: Basic degree in scientific or relevant discipline (BS or equivalent) o Desirable: Advanced degree in scientific or relevant discipline (MS or equivalent)
o Fluent English (oral and written) required; fluent in site-language desirable o At least 3 years of relevant experience.
o Ability to influence people, negotiate and communicate.
o Sound scientific, technical and regulatory knowledge in a specific area.
o Excellent knowledge of cGMPs, working knowledge of safety and environmental regulations and guidelines.
o Good knowledge of drug development. o Good organizational skills.
o Good and proven ability to analyze and evaluate GMP compliance.