Job Description

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 5–7 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.