Job
Description
The Associate Director, R&D Quality Lead, is responsible for ensuring the highest standards of quality and compliance within the Research and Development (R&D) function. This role encompasses oversight of Good Clinical Practice (GCP) audits, Corrective and Preventive Actions (CAPA) management, digital initiatives, and managing a team of quality professionals. The R&D Quality Lead will report into the Global Quality, Hyderabad Quality Lead, and work closely with cross-functional teams to ensure that all R&D activities meet regulatory requirements and internal quality standards. Key Responsibilities Line management responsibility to oversee team performance, provide guidance and development opportunities, ensuring operational efficiency and alignment with departmental and organizational objectives. Collaborate with cross-functional teams, including but not limited to R&D Quality, Global Quality, Global Drug Development, IT to ensure the timely and effective resolution of quality issues, and to share lessons learned and best practices. Oversee internal and external auditing processes, ensuring compliance with regulatory standards and company policies. Drive innovation in quality management practices, identifying opportunities for improvement and implementing best practices. Foster a culture of quality and continuous improvement within the organization. Develop and deliver training programs to enhance the quality capabilities of the organization. Monitor and analyze quality performance metrics, reporting on trends and implementing corrective actions as needed. External engagement as needed with industry/trade/QA associations, regulatory agencies, vendors, and licensing partners as well as pharmaceutical company peers. Actively share knowledge with others across multiple disciplines and across lines through existing knowledge sharing processes and systems. Qualifications & Experience Education and Experience: B.S. and/or M.S. in Chemistry, Biology, or Health or Quality related field or equivalent combination of education, training, and experience Minimum 15+ years of GxP experience in Quality, Clinical Development and Regulatory Compliance. Required Competencies: Knowledge, Skills, and Abilities Demonstrated applied knowledge of ICH/GCP, regulatory guidelines/directives, clinical research processes and principles of Quality Assurance. Extensive experience in GxP (GCP and GVP) auditing, CAPA Management and IT architecture and solutions. Very experienced in Nonclinical, Clinical and Pharmacovigilance processes. Demonstrated analytical and conceptual capability including proficiency in utilizing data and ability to formulate clear business questions that can be answered with data. Proven track record of leading and managing cross-functional teams. Proven problem-solving skills to prevent and overcome complex process and quality related issues during clinical program implementation and execution. Communication Skills: Communicates professionally, clearly, concisely and consistently both verbally and in writing to internal and external customers; excellent presentation skills for compelling peer and Senior Management communication. Project Management: Must be able to manage complex assignments/projects and effectively deliver all expected deliverables in a timely manner and proactively communicate changes in pre-established goals and deadlines. Considers global influences, situations, and implications when making plans or decisions, solving problems, or developing strategies. Responds resourcefully to changing business conditions and opportunities, proactively looking for ways the organization can adapt its plans, tactics, or strategies. Ability to drive change and foster a culture of continuous improvement. Fluent in English, with proven professional working proficiency in English for reading, writing and speaking.
