QA Manager Compliance, Systems and Inspections (m/f/d)

Location: Basel

Workload: 100%

Duration: 1 year/will be extended

Responsibilities:

• End-to-end support of GMP inspections
• Proactive preparation of inspections for all IMP areas (organization and technical support of SMEs)
• Active role in the inspection (front office/ back office)
• Follow-up of the inspection (response process, follow-up of measures)
• Ensuring the timely and compliant fulfilment of all commitments made to the health authorities
• Interface with the Manufacturing network with regard to GMP inspections for holistic and proactive inspection preparation
• Supervision of the self-inspection program
• Support in the implementation of Data Integrity (DI) requirements
• Support of the QMS Business Process Managers in Quality Systems matters
• Responsible for the management and optimization of initiatives and improvements within IMP Quality Switzerland.
• Partnership with stakeholders and collaboration for the successful implementation of the IMP objectives
• Strong communication and matrix leadership in the context of GMP inspections

Requirements:

• Academic degree in natural sciences (pharmacy, chemistry or equivalent)
• At least 5 years of professional experience in the pharmaceutical industry, especially in the production of drug substance, drug product and finished product
• At least 5 years of professional experience in GMP inspections by health authorities and the current expectations of Swissmedic
• Excellent knowledge of global quality and GMP requirements
• In-depth understanding of current data integrity requirements
• Strong team player with high self-motivation and the ability to effectively influence others across all levels of the organization
• Matrix Leadership Skills
• Fluent German and very good English skills are mandatory for this position