Director of Quality
3 weeks ago
Molecular Search is proud to collaborate with a premier CDMO specializing in drug product development and manufacturing. Our client is dedicated to delivering high-quality pharmaceutical solutions to enhance patient health and well-being.
Responsibilities:
Lead the development and implementation of the quality strategy and quality management system for drug product manufacturing operations.
Oversee all aspects of quality assurance and quality control activities, ensuring compliance with cGMP regulations, industry standards, and company policies.
Provide strategic guidance and direction to ensure the efficient and effective execution of quality processes, including batch release, deviation management, change control, and investigations.
Collaborate closely with cross-functional teams, including manufacturing, regulatory affairs, and R&D, to drive continuous improvement initiatives and ensure product quality and compliance.
Partner with clients and regulatory agencies to address quality-related issues, participate in audits and inspections, and ensure timely resolution of compliance concerns.
Implement quality metrics and performance indicators to monitor and track quality performance, identify trends, and drive process improvements.
Stay abreast of industry trends, regulatory requirements, and best practices in quality management, and proactively identify opportunities to enhance quality systems and processes.
Qualifications:
Extensive knowledge of cGMP regulations, quality systems, and industry standards applicable to drug product manufacturing.
Strong understanding of quality assurance and quality control principles and practices, including batch release, deviation management, change control, and investigations.
Proven track record of leading and developing high-performing quality teams, driving operational excellence, and ensuring compliance with regulatory requirements.
Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams and build strong relationships with clients and regulatory agencies.
Strategic mindset, with the ability to develop and execute quality strategies aligned with business objectives and regulatory requirements.
Strong problem-solving and decision-making abilities, with a focus on driving results and continuous improvement.
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