R&D Quality Manager

Key Responsibilities:

• Manages technical complaints investigations to determine root causes and implement corrective actions to prevent recurrence.
• Collaborate with cross-functional teams to gather data, lead, and perform Root Cause Analysis to identify the likely root cause of events.
• Review and approve complaints as the site Investigation approver.
• Manage multiple investigations concurrently.
• Periodically analyze trends in technical complaints.
• Participate in audits and inspections, including inspection readiness activities.
• Handle data integrity escalations.
• Implement and drive global Data Integrity (DI) network initiatives

Essential Requirements:

• More than Over 10 years of practical experience in the chemical/pharmaceutical industry or over 5 years of experience in pharmaceutical operations. In-depth knowledge of pharmaceutical facilities, manufacturing, and laboratory systems and processes-.
• Proficient in conducting Root Cause Investigations. Effectively collaborate with the Investigation team to ensure timely completion.
• Experienced in cGMP manufacturing, Quality, and Compliance.
• Action-oriented with strong skills in building relationships, problem-solving, planning and organizing, conflict management, coaching, and analytical thinking.
• Capable of completing routine tasks with minimal direction
• Fast learning abilities, able to manage investigations related to small molecule, biologic and CGT products as well as medical devices, packaging and distribution related topics
• Able to promptly communicate roadblocks and challenges, ensuring timely delivery of investigations.
• Excellent verbal and written communication skills.
• Project Management
• Sound knowledge of current international regulatory regulations, cGxP requirements and best practices, including EU-GMP guidelines