Quality Unit Director

We are seeking a Quality Unit Director for an international pharmaceutical contract manufacturing company. This role will be responsible for overseeing Quality Assurance and Quality Control (chemical and microbiological laboratories) ensuring full compliance with GMP and regulatory requirements.

Key Responsibilities:

1. Develop and implement quality strategies to optimize manufacturing processes and maintaining compliance.
2. Ensure GMP compliance and adherence to international regulatory standards (FDA, EMA, AIFA, etc.).
3. Act as the Qualified Person (QP).
4. Lead and manage the team, fostering a culture of quality and continuous improvement and ensuring training programs.
5. Oversee batch release activities, deviations, CAPA, change controls, and risk assessments, ensuring timely resolution and documentation.
6. Lead internal and external audits, including regulatory inspections and customer audits, and drive audit readiness.

Requirements:

1. Bachelor's or Master’s degree in Chemistry, Pharmaceutical Sciences, Biology, or a related field.
2. Recognized QP eligibility under EU Directive 2001/83/EC.
3. Proven experience in Quality Leadership roles within a pharmaceutical manufacturing environment.
4. Strong knowledge of GMP, ICH guidelines, and regulatory requirements (FDA, EMA, AIFA).
5. Excellent leadership, decision-making, and problem-solving skills.