QA Director

As the Quality Assurance (QA) Director at this CDMO, you will play a pivotal role in ensuring the highest standards of quality and compliance within THEIR aseptic and sterile manufacturing operations. Reporting directly to the Chief Quality Officer (CQO), you will lead a team of QA professionals and collaborate closely with cross-functional teams to drive excellence in quality systems, regulatory compliance, and continuous improvement initiatives.

Responsibilities:

• Develop and implement the overall quality strategy aligned with business objectives and regulatory requirements.
• Ensure compliance with relevant regulatory standards and guidelines, including but not limited to FDA, EMA, and ANSM regulations.
• Oversee the development, implementation, and maintenance of robust quality management systems (QMS) to ensure product quality, safety, and efficacy.
• Provide leadership and direction to the QA team in all aspects of quality assurance, including batch release, deviations, investigations, change control, and CAPA management.
• Establish and maintain effective supplier quality management processes to ensure the quality and compliance of raw materials and components sourced from suppliers.
• Act as a primary point of contact for customer quality-related inquiries, audits, and inspections, ensuring customer satisfaction and retention.
• Drive a culture of continuous improvement by identifying opportunities for process optimization, efficiency gains, and quality enhancements.
• Develop and implement training programs to ensure that all QA personnel are adequately trained and competent to perform their roles effectively.
• Establish key quality performance indicators (KPIs) and metrics, and provide regular reports to senior management on quality performance and compliance status.
• Coordinate and manage internal and external audits, including regulatory inspections, customer audits, and third-party audits, ensuring timely closure of audit findings and observations. 

Qualifications:

• Bachelor's degree in a relevant scientific discipline; advanced degree preferred.
• Minimum of 10 years of experience in pharmaceutical quality assurance, with significant experience in aseptic and sterile manufacturing environments.
• In-depth knowledge of regulatory requirements pertaining to aseptic processing, sterile manufacturing, and quality systems (e.g., GMP, ISO, ICH guidelines).
• Strong leadership and managerial skills, with the ability to lead and develop a high-performing QA team.
• Excellent communication, interpersonal, and negotiation skills, with the ability to interface effectively with internal stakeholders, customers, and regulatory agencies.
• Proven track record of successful regulatory inspections and audits.
• Fluency in French and English; additional languages a plus.