We are a rapidly expanding chemical contract manufacturing company specializing in cGMP-compliant operations across multiple sites. Our expertise spans pharmaceuticals, foods, coatings, paints, adhesives, and polymers, serving diverse industries with innovative solutions. As we continue to grow, we are seeking a dynamic and experienced Director of Quality to lead our quality assurance and control functions.
Position Overview:
As the Director of Quality, you will play a pivotal role in ensuring the highest standards of quality across our multi-site operations and be responsible for overseeing all aspects of incoming and outgoing material quality, as well as final product quality assurance. Your strategic and tactical leadership will be crucial in driving continuous improvement initiatives and maintaining regulatory compliance within a dynamic manufacturing environment.
Key Responsibilities: • Develop and implement quality assurance policies, procedures, and systems to ensure compliance with cGMP standards across all manufacturing facilities. • Establish and maintain robust quality control processes for incoming materials, in-process production, and finished products. • Lead and mentor a team of quality professionals, providing guidance and fostering a culture of quality excellence. • Collaborate closely with manufacturing, R&D, regulatory affairs, and supply chain departments to ensure seamless integration of quality standards and practices. • Drive continuous improvement initiatives to enhance product quality, operational efficiency, and customer satisfaction. • Conduct regular audits and inspections to assess compliance with regulatory requirements and company standards. • Manage quality-related investigations, deviations, and CAPA (Corrective and Preventive Action) plans to address non-conformances promptly. • Serve as the primary quality contact for clients, effectively communicating quality metrics, trends, and performance to ensure alignment with customer expectations. • Stay abreast of industry trends, regulatory updates, and best practices to proactively adapt quality systems and processes.
Qualifications: • Bachelor's degree in Engineering (Chemical, Mechanical, or related field) preferred; advanced degree (Masters) a plus. • Minimum of 10 years of progressive experience in quality management within a cGMP manufacturing environment, ideally across pharmaceuticals, foods, coatings, paints, adhesives, and polymers. • Strong understanding of regulatory requirements (FDA, EU, etc.) and experience with audits from regulatory agencies and customers. • Proven track record of leading successful quality programs and initiatives, with a focus on continuous improvement and operational excellence. • Excellent leadership and people management skills, with the ability to inspire and motivate cross-functional teams. • Exceptional communication and interpersonal skills, with the ability to effectively interact with stakeholders at all levels of the organization and external clients. • Strategic thinker with a demonstrated ability to translate business goals into actionable quality strategies.
Benefits: • Competitive salary and comprehensive benefits package. • Opportunities for career growth and advancement in a fast-paced, innovative environment. • Collaborative and inclusive company culture that values teamwork and professional development.
Application Process: If you are a strategic thinker with a passion for quality and a proven track record of success in cGMP manufacturing environments, we encourage you to apply for this exciting opportunity. Please submit your resume and cover letter outlining your qualifications and why you are interested in joining our team.