Head of Quality - Generics (Pharmaceutical)

Job SummaryThe Head of Quality is a pivotal leadership position tasked with upholding the highest standards of quality and compliance throughout the organization’s operations. Reporting to senior management, this role involves overseeing the creation, implementation, and maintenance of robust quality management systems to ensure regulatory compliance, product safety, and customer satisfaction.ResponsibilitiesDevelop and implement comprehensive quality management strategies, policies, and procedures to ensure adherence to regulatory requirements (e.g., FDA, EMA) and industry standards (e.g., GMP, GDP, GCP).Lead and guide the quality assurance and quality control teams, fostering a culture of excellence, accountability, and continuous improvement.Establish and monitor key performance indicators (KPIs) to evaluate and track quality metrics, including product quality, batch release times, deviation/incident rates, and customer complaints.Conduct risk assessments and implement risk management strategies to mitigate quality-related risks throughout the product lifecycle.Lead internal and external audits, including regulatory inspections, ensuring timely resolution of audit findings and implementation of corrective and preventive actions (CAPAs).Collaborate with cross-functional teams, including R&D, manufacturing, supply chain, and regulatory affairs, to ensure alignment and integration of quality objectives across the organization.Stay current with evolving regulations, industry trends, and best practices in quality management, and proactively implement necessary changes to maintain compliance and drive continuous improvement.Promote a culture of quality and compliance through training, education, and communication initiatives, ensuring all employees understand their roles and responsibilities in maintaining product quality and safety.Serve as the primary point of contact for regulatory agencies and external partners/vendors on quality-related matters, representing the organization with professionalism and integrity.Drive initiatives to enhance operational efficiency, optimize resource utilization, and reduce costs while maintaining high standards of quality and compliance.Skills and QualificationsBachelor’s degree in pharmacy, Chemistry, Biology, or a related field; advanced degree (e.g., Master’s, PhD) preferred.Extensive experience (minimum 8-10 years) in quality assurance/quality control roles within the pharmaceutical industry, with at least 5 years in a leadership or management position.In-depth knowledge of relevant regulations and standards (e.g., FDA, EMA, ICH) governing pharmaceutical manufacturing, distribution, and quality management systems.Proven track record of successful leadership in developing and implementing quality strategies, driving compliance, and leading cross-functional teams in a matrix environment.Strong analytical, problem-solving, and decision-making skills, with the ability to prioritize and manage multiple projects simultaneously.Excellent communication, interpersonal, and influencing skills, with the ability to effectively interact with stakeholders at all levels of the organization.Certification in quality management (e.g., ASQ Certified Quality Manager, Six Sigma Black Belt) is a plus.