Quality Head India

Job Description About the Role Establish and Maintain Quality Systems: Develop and sustain robust Quality Systems to support cGMP activities, ensuring compliance with regulatory requirements and industry standards. Manage Quality Control (analytical/Microbiology) and Assurance Departments Responsibilities - Oversee Document Control and Training Systems: Oversee document control and training system management, ensuring accurate documentation and effective personnel training. - Demonstrate Regulatory Expertise: Possess strong knowledge of cGMP, Quality Systems, and regulatory guidance, providing expertise to ensure compliance in areas such as Qualification and Validation processes, clinical trials, and BLA submissions. - Direct Quality Operations Activities: Lead Quality Operations related to product disposition, ensuring final approval for market release in compliance with regulatory requirements. - Lead Cross-Functional Teams: Guide cross-functional teams to resolve quality issues, implement necessary Corrective and Preventive Actions (CAPAs), and promote continuous improvement initiatives. - Vendor Management Collaboration: Work with Vendor Management to meet vendor quality requirements, maintaining effective relationships with key suppliers and partners. - Drive Continuous Improvement: Collaborate with technical operations teams and company leadership to implement programs aimed at enhancing product quality, operational efficiency, and compliance. - Supervise QA and QC Managers: Oversee Quality Assurance and Quality Control managers, including performance management, planning, and conducting reviews. - Prepare for and Manage Regulatory Inspections: Get ready for and handle regulatory agency inspections, ensuring preparedness and successful outcomes. - Recruit, Develop, and Retain Quality Personnel: Hire, develop, and retain skilled quality personnel to build and sustain a high-performing team. - Provide Performance Feedback: Offer formal and informal feedback to employees, making decisions regarding development, promotions, and salary adjustments. - Ensure Compliance and Oversight: Guarantee adherence to all company policies and standards by overseeing the creation and review of key quality documents. - Global Collaboration: Strategically plan and coordinate quality and compliance activities worldwide, working with staff in various locations. - Cultivate a Culture of Compliance and Continuous Improvement: Promote and establish a company-wide culture focused on compliance and ongoing improvement, supporting the enhancement of Quality Management Systems. - Lead Quality Responses and Initiatives: Manage quality responses to information requests and business proposals, and spearhead process improvements related to quality. - Technical Liaison and Training: Serve as the technical point of contact between Quality and other functions, while organizing and promoting training activities related to quality and compliance in coordination with Learning & Development. - Regulatory Knowledge and Compliance: Keep updated on FDA, EU, MHRA, and EMA regulations and standards, ensuring all activities comply. - CAPA and Complaint Management: Maintain effective systems for Corrective and Preventive Actions (CAPA), nonconformance, and complaints, ensuring timely resolution. - Travel and Other Duties: Travel up to 10%, including internationally, and perform additional duties as assigned. - Qualifications M. Sc/ M. Tech (Prefer Biotechnology) / M. Pharm. - Additional qualifications in industrial administration or management are a plus. - Education details:20+ years of experience in BioPharma / sterile manufacturing with at least 57 years in a senior leadership role (Plant Head or Site Head). - Proven track record of managing both technical operations and plant administration in a regulated environment. - Hands-on experience in facing global regulatory audits (USFDA, EMA, WHO, etc.). Required Skills - Strong technical depth in biologics, injectables, or sterile manufacturing. - Proven administrative and infrastructure management capabilities. - Excellent regulatory knowledge and statutory compliance understanding. - Strong leadership, decision-making, and cross-functional collaboration skills. - Vendor and budget management expertise. - Crisis management and stakeholder engagement.