Job Description

Alcott Global is partnering with a leading Pharmaceutical Manufacturing company to search for their Head Quality & Regulatory Affairs. The role will be based in Hyderabad/Bengaluru.

ROLE OVERVIEW:

The Quality Leader  will be responsible for defining and driving the organization’s overall Quality strategy across manufacturing sites and R&D facilities, ensuring full compliance with global regulatory requirements, and product quality goals. The position requires deep expertise in GxP environments, strong regulatory acumen, and the ability to influence senior stakeholders while building sustainable quality capabilities within the organization.

KEY RESPONSIBILITIES:

• Provide strategic leadership: Develop and implement global quality/regulatory strategies,  policies, and standards that align with business goals
• Regulatory compliance: Ensure total compliance with GMP, ICH, ISO standards, and other  applicable regulatory requirements in various jurisdictions
• Quality Management System: Oversee the establishment, maintenance, and enhancement of  a robust QMS to drive operational efficiency
• Client Management: Act as a primary high level contact for clients regarding quality, providing  transparency and trust
• Audit and Inspection Management: Lead in preparation for and management of regulatory  inspections and customer / client audits. Strive towards any time readiness for audits
• Risk Management: Formulate risk management and mitigation strategies to identify potential  issues and implement preventive measures
• Continuous Improvements: Drive initiatives to reduce defects, optimize process, and reduce  cost using Lean Six Sigma, automation, digitalisation or similar methodologies
• Team Leadership: Manage QA, QC and Compliance Teams across multi site operations,  fostering a culture of quality
• Responsibility for designing ,implementing ,and ensuring compliance to all quality related SOP  at manufacturing sites and R&D facilities.
• Ensure availability of adequate resource, including man power to maintain compliance with GxP  requirements
• System harmonization across various sites to have uniform quality systems
• Provide Quality Leadership to the organisation and build people capability in the company.  Identify critical roles and plan for succession for those roles internally

REQUIRED SKILLS & QUALIFICATIONS:

• PhD in Organic Chemistry (Preferred) with some hands on experience in Analytical Methods
• 15+ years of progressive experience in Quality Management within a CDMO, CRDMO or large  pharmaceutical environment
• Must have been in leadership position for 5+ years
• In depth knowledge of various regulatory standards
• Exceptional communication and influencing skills
• Capable of engaging both internal and external stakeholders