Associate Manager, Manufacturing Compliance Support

Job summary

This role involves leading a Compliance Support Team within a pharmaceutical manufacturing environment, focusing on a full production line from cell culture to purification. The Associate Manager will oversee a team of Investigators, ensuring compliance with GMP standards while optimizing deviation processes and enhancing quality metrics.

Qualifications

• Demonstrated experience in people management within GMP manufacturing or quality/compliance sectors.
• Proven skills in deviation management, root cause analysis, CAPA, and risk assessment.
• Familiarity with operational excellence, LEAN methodologies, and flow optimization.
• Knowledge of cGMP, data integrity, and documentation standards in the pharma/biotech industry.
• Experience with API production, particularly in cell culture and purification processes is advantageous.
• Strong planning and coordination abilities in a fast-paced environment.
• Effective communication skills with stakeholders across various departments.
• Proactive and solution-oriented mindset, capable of challenging the status quo.
• Proficient in English; knowledge of Danish is a plus.

Responsibilities

Working Hours

• Lead and develop a high-performing team of Investigators.
• Manage workload, set priorities, and ensure team motivation and accountability.
• Oversee daily planning and queue management to meet lead time targets.
• Ensure quality investigations and robust documentation of deviations.
• Implement standard work practices and performance metrics.
• Optimize collaboration with Manufacturing and QA to ensure smooth operations.
• Maintain audit readiness through compliance and data integrity measures.
• Foster cross-training and capability building within the team.
• Communicate effectively regarding changes and risks, ensuring follow-through on actions.
• Deliver results in line with internal and customer agreements while upholding safety and compliance standards.
• Primarily Monday to Friday during daytime hours, with flexibility for critical escalations as needed.