Job Purpose
To provide strategic leadership and oversight for all Quality functions at the site, ensuring compliance with global regulatory requirements, corporate quality standards, and current Good Manufacturing Practices (cGMP). The incumbent will be responsible for maintaining a robust Quality Management System (QMS) and ensuring regulatory readiness of the USFDA-approved formulation manufacturing facility producing Tablets, Capsules and Powder formulations for international markets.
Key Responsibilities
Quality Leadership & Strategy
· Lead and manage all Quality functions including Quality Assurance (QA), Quality Control (QC), Validation, Compliance, Documentation, Microbiology (if applicable), and Stability Studies.
· Develop and implement site quality strategy aligned with business objectives and global regulatory expectations.
· Drive a culture of quality, compliance, continuous improvement, and data integrity across the organization.
· Act as the Quality Management Representative for the site.
Quality Assurance
· Ensure effective implementation and maintenance of Quality Management Systems (QMS).
· Review and approve quality policies, SOPs, specifications, protocols, reports, and master documents.
· Ensure effective management of deviations, OOS, OOT, CAPA, change controls, risk assessments, complaints, recalls, and annual product quality reviews.
· Monitor and improve quality metrics and compliance indicators.
Quality Control
· Ensure robust analytical testing and release systems for raw materials, packing materials, in-process samples, finished products, stability samples, and water systems.
· Oversee laboratory compliance, method validation, method transfer, calibration, and qualification activities.
· Ensure compliance with ALCOA+ principles and data integrity requirements.
Regulatory Compliance & Audits
· Ensure continuous compliance with USFDA, MHRA, EU GMP, WHO-GMP, PIC/S, and other applicable regulatory requirements.
· Lead site readiness and management of regulatory inspections and customer audits.
· Act as primary quality representative during regulatory inspections.
· Ensure timely closure of audit observations and implementation of sustainable CAPAs.
Validation & Qualification
· Oversee qualification and validation programs including:
o Equipment Qualification
o Process Validation
o Cleaning Validation
o Computer System Validation
o Utility Qualification
o Analytical Method Validation
Data Integrity & Quality Systems
· Establish and maintain a strong Data Integrity framework across manufacturing and laboratory operations.
· Ensure compliance with 21 CFR Part 11 and global regulatory expectations.
· Drive periodic reviews and effectiveness checks of quality systems.
Team Management
· Lead, mentor and develop the Quality organization.
· Build succession planning and talent development initiatives within the department.
· Foster cross-functional collaboration with Production, Engineering, Warehouse, Supply Chain, Regulatory Affairs, and Technical Services.
Continuous Improvement
· Drive operational excellence and quality improvement projects.
· Utilize quality metrics and trend analysis for proactive risk management.
· Promote Lean, Six Sigma, and continuous improvement initiatives.
Regulatory Exposure Required
The candidate should have hands-on experience in handling inspections and audits from:
· USFDA
· MHRA
· EU Authorities
· WHO-GMP
· TGA
· Health Canada (preferred)
· Customer Audits from regulated markets
Educational Qualification
· M.Pharm / B.Pharm / M.Sc. (Chemistry, Pharmaceutical Chemistry, Microbiology or related discipline)
· Additional qualifications in Quality Management, Regulatory Affairs, Six Sigma, or Operational Excellence will be preferred.
Experience
Age limit 45 – 48 yrs
Candidates should be only from Tablet / Capsule manufacturing USFDA Approved plant
· 18–25 years of experience in pharmaceutical manufacturing quality functions.
· Minimum 8–10 years in senior leadership roles heading Quality operations.
· Proven experience in managing Quality functions at a USFDA-approved formulation manufacturing facility.
· Strong exposure to Oral Solid Dosage (OSD) manufacturing including Tablets, Capsules and Powder formulations.
Key Competencies
Technical Competencies
· Quality Management Systems (QMS)
· Regulatory Compliance
· Data Integrity
· GMP & GDP Compliance
· Validation & Qualification
· Laboratory Compliance
· Risk Management
· Inspection Readiness
· Product Quality Review
· Root Cause Analysis & CAPA
Leadership Competencies
· Strategic Thinking
· Team Leadership & Development
· Stakeholder Management
· Decision Making
· Change Management
· Problem Solving
· Result Orientation
· Communication & Influencing Skills
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