Job Description

Rx Group are supporting a global pharmaceutical organisation, with a QC Director for an on-site position in Indiana. As the QC Director, you will play a crucial role in ensuring the quality and safety of our pharmaceutical products through effective leadership, strategic planning, and in-depth expertise in microbiology.

Role and Responsibilities

• Develop and execute the QC strategy aligned with business goals and regulatory requirements.
• Provide visionary leadership for continuous improvement in quality control processes.
• Stay abreast of global regulatory changes and ensure departmental compliance.
• Direct and oversee microbiological testing, ensuring accurate and timely results.
• Act as the primary contact for microbiology-related matters, providing expertise.
• Establish and maintain robust quality control systems, including SOPs.
• Implement and monitor key performance indicators (KPIs) for process improvement.
• Recruit, train, and manage a skilled QC team, fostering collaboration and learning.
• Collaborate with cross-functional teams to integrate QC processes across the product life cycle.
• Manage relationships with external vendors and CROs involved in QC testing.
• Oversee validation and qualification of QC testing methods, equipment, and processes.
• Drive continuous improvement initiatives and conduct regular reviews for efficiency.

Experience and Qualifications

• Bachelor's, Master’s, or Ph.D. degree in Microbiology, Biology, or related field.
• Minimum of 10 years of experience in Quality Control leadership roles within the pharmaceutical industry.
• Extensive experience in microbiology with a strong understanding of testing methodologies, microbial identification, and environmental monitoring.
• Proven track record of successful implementation and management of quality systems in compliance with regulatory standards.
• Excellent leadership and communication skills, with the ability to influence and collaborate effectively at all organizational levels.
• Strong problem-solving skills and the ability to make sound decisions under pressure.

Location:

This position is based in Indiana, USA. The role requires on-site presence to oversee QC operations and collaborate with cross-functional teams.