Beschreibung

In this role, you will manage chemical testing activities to ensure compliance and support production needs. Your day-to-day responsibilities will involve overseeing QC operations, mentoring the team, and collaborating across functions to drive continuous improvement and maintain audit readiness.

Anforderungen

• •Master’s degree or Bachelor in Analytical Chemistry, Chemistry, or Biology with extensive practical experience in GMP related field
• •Sufficient qualification for Head of Quality Control
• •Minimum of 5-10 years of regulated industry experience in QC with demonstrated knowledge of related quality systems and regulatory requirements
• •Hands-on and management experience in chemical testing and relevant method validation/transfer per ICH guideline, including HPLC and UV-Vis
• •Experience in working with Empower, LIMS and LES, ideally also in LIMS introduction
• •People management
• •Written and oral skills in German and English
• •Participation in regulatory inspections such as EMA, FDA, etc.
• •Management experience of third-party laboratories

Aufgaben

• •Ensure timely completion of work to support batch release and site priorities
• •Adhere to Environmental Health and Safety (EHS) requirements and laboratory safety procedures
• •Maintain cleanliness and contamination control in line with cGMPs and biosafety guidelines
• •Lead compliance activities with standard operating procedures (SOPs) and regulatory guidelines
• •Ensure data integrity in accordance with ALCOA+ principles
• •Manage data review to ensure accuracy and compliance
• •Identify and escalate atypical results and potential deviations
• •Participate in root cause analysis for laboratory investigations
• •Implement corrective and preventive actions as required
• •Communicate opportunities for continuous improvement
• •Participate in cross-functional teams as needed
• •Maintain training competencies and execute work only when qualified
• •Participate in training and mentorship as requested
• •Support audit readiness and participate in pre-inspection reviews
• •Oversee and coordinate QC Chemical Testing activities to meet production needs
• •Proactively manage workload for on-time delivery
• •Engage with QC personnel to monitor activities and resolve issues
• •Adjust resources to maintain smooth QC operations
• •Address atypical results and operational problems directly with personnel
• •Supervise the Chemical Testing team and set clear objectives
• •Monitor team performance and provide ongoing coaching and feedback
• •Conduct regular one-on-one check-ins with team members
• •Recognize high performance and handle employee relations issues fairly
• •Serve as the liaison between QC and other site functions
• •Share and adopt best practices to drive operational excellence
• •Ensure QC area is ready for inspection and address compliance gaps
• •Manage laboratory costs and approve invoices as requested

Tools & Technologien

Benefits