Beschreibung

In this role, you will lead quality assurance efforts, ensuring compliance with GxP and cGMP standards while guiding the Quality Assurance team. Your day-to-day responsibilities will include strategic planning, stakeholder coordination, and managing critical quality issues.

Anforderungen

• •BS/MSc in Life Sciences or related experience
• •10 years of experience in GMP Pharmaceutical Manufacturing
• •At least 3 years in Quality Control and/or Quality Assurance
• •Proven track record in supporting Quality Control operations
• •In-depth knowledge of cGMP and FDA regulations
• •Ability to manage multiple projects with moderate complexity
• •Highly developed management and communication skills
• •Strong organizational and time management skills
• •Experience in process improvement approaches

Aufgaben

• •Provide leadership for strategic site initiatives
• •Represent site quality in local and global project teams
• •Support and direct the Quality Assurance department staff
• •Ensure staff are qualified, competent, and motivated
• •Create user requirements and specifications for projects
• •Coordinate with stakeholders for clear communication
• •Ensure facilities and equipment are safe and compliant
• •Oversee project planning, construction, and qualification
• •Maintain updated project plans to track progress
• •Escalate risks related to timelines and budgets
• •Manage product critical quality issues and deviations
• •Ensure effective execution of investigations and CAPAs
• •Define and monitor Site Quality KPIs
• •Establish and oversee the Site Quality Committee
• •Coordinate the execution of Site Quality Plans and assessments
• •Prepare and consolidate the Quality Unit budget
• •Ensure adherence to health and safety procedures

Tools & Technologien