Head - Site Quality (AVP)

Sentiss Pharma Pvt. Ltd.; Solan; On-site; INR 2,000,000 - 2,500,000; Full time

Job summary

Sentiss Pharma Pvt. Ltd. is seeking a Site Quality Head responsible for overseeing Quality Assurance, Quality Control, and Microbiology operations at a sterile manufacturing site. The role emphasizes compliance with USFDA and global regulatory requirements, requiring 15+ years of experience in pharmaceutical quality management.

The ideal candidate will have hands-on experience in USFDA inspections, leading QA/QC teams, and driving operational excellence within a quality-focused culture. Strong leadership and a commitment to embedding Sentiss values are key.

Qualifications

• Deep hands-on exposure to IPQA.
• Experience in closing or facing USFDA inspections.
• Ability to drive Operational Excellence while embedding Sentiss values.

Responsibilities

• Lead site Quality strategy to ensure compliance with regulatory requirements.
• Act as the primary Quality representative during regulatory inspections.
• Provide leadership to IPQA and ensure strong Quality oversight.
• Own and strengthen the Quality Management System (QMS).
• Demonstrate Operational Excellence and drive continuous improvement.

Skills

Master’s degree in Pharmacy, Pharmaceutical Sciences, Microbiology, or relevant discipline

15+ years of progressive experience in pharmaceutical Quality

Proven experience in USFDA inspections and remediation

Strong background in IPQA

Sound understanding of global cGMPs and quality risk management principles

Experience leading QA + QC + Microbiology teams

Education

Master’s degree in Pharmacy, Pharmaceutical Sciences, Microbiology, or relevant discipline

Job description

The Site Quality Head is responsible for end‑to‑end Quality Assurance, Quality Control, and Microbiology operations at a sterile manufacturing site, with a strong emphasis on USFDA compliance, remediation leadership, and sustained inspection readiness.

The role demands deep hands‑on exposure to IPQA, proven experience in closing or facing USFDA inspections followed by successful remediation, and the ability to drive Operational Excellence while embedding Sentiss values across the Quality organization.

Skillset Required

• Master’s degree in Pharmacy, Pharmaceutical Sciences, Microbiology, or relevant discipline.
• 15+ years of progressive experience in pharmaceutical Quality, with significant exposure to sterile manufacturing.
• Proven experience in USFDA inspections and remediation, including hands‑on involvement post‑inspection. MHRA, ANVISA and others.
• Strong background in IPQA, aseptic operations, contamination control, and sterile validations.
• Prior experience leading QA + QC + Microbiology teams at a manufacturing site.
• Sound understanding of global cGMPs and quality risk management principles.

1. Regulatory Compliance & USFDA Remediation Leadership

• Lead site Quality strategy to ensure full compliance with USFDA, EU GMP, MHRA and other global regulatory requirements, specifically for sterile and aseptic operations.
• Demonstrated experience of facing and/or closing USFDA inspections, including:
• Responding to Form 483 observations and Warning Letter remediation (where applicable).
• Driving root cause analysis, systemic CAPAs, and sustainable remediation programs.
• Managing remediation governance, metrics, and commitments till closure.
• Act as the primary Quality representative during regulatory inspections, audits, and corporate compliance reviews.
• Ensure sustained post‑remediation compliance, inspection readiness, and quality culture maturity.

2. Sterile Manufacturing & IPQA Excellence

• Provide strong hands‑on leadership to IPQA, with direct involvement in:
• Aseptic processing, cleanroom operations, and contamination control.
• Line clearance, batch execution review, deviation management, and real‑time quality decision‑making.
• Media fills (APS), sterile process validations, EM trending, and sterility assurance.
• Ensure strong Quality oversight of:
• Sterile ophthalmic / injectable manufacturing operations.
• Utilities (WFI, Clean Steam, HVAC), cleanroom classifications, and gowning practices.
• Act as a quality coach on the shop floor, ensuring decisions are science‑, risk‑ and patient‑centric.

3. Quality Systems, Risk Management & Data Integrity

• Own and strengthen the Quality Management System (QMS), including:
• Deviations, OOS/OOT, Change Control, CAPA, Complaints, Recalls, and Risk Management.
• Product Quality Reviews (PQR/APQR) with robust trending and control strategies.
• Ensure data integrity and ALCOA+ compliance across QA, QC, Micro, and manufacturing systems.
• Drive effective risk‑based decision making aligned with regulatory expectations and business needs.
• Provide integrated leadership across QA, QC (Chemical & Instrumental), and Microbiology functions.
• Ensure:
• Robust analytical and microbiological testing, method validations, EM programs, and laboratory compliance.
• Timely product disposition and batch release for regulated markets.
• Build strong collaboration between Quality and Operations while preserving Quality independence.

5. Operational Excellence & Continuous Improvement

• Demonstrate a clear inclination toward Operational Excellence, focusing on:
• Simplification of quality processes without compromising compliance.
• Reduction of batch release cycle times, deviation recurrence, and investigation timelines.
• Leverage risk management, trending, and CAPA effectiveness reviews to drive lasting improvements.
• Lead, mentor, and develop a high‑performing Quality organization with strong people engagement.
• Be recognized as a hands‑on leader with approachability, coaching mindset, and conflict‑resolution skills.
• Build quality ownership across functions through training, influence, and collaboration.
• Promote Sentiss values by demonstrating:
• Integrity, accountability, respect, and patient focus.
• Ethical decision‑making and transparency in Quality operations.

COMPETENCIES

• Regulatory & Inspection Leadership
• USFDA Remediation & Compliance Mindset
• Hands‑on IPQA & Sterile Operations Expertise
• Operational Excellence Orientation
• Strong People & Stakeholder Management
• Decision‑making with Patient & Compliance Focus
• Alignment to Sentiss Values and Ethical Leadership