Quality Lead - Pharmaceutical Manufacturing (Lean, High-speed operation)
Reports to: General Manager
Purpose of Role:
To act as the accountable Quality authority for a lean pharmaceutical manufacturing site operating high-speed, continuous production lines at >90% efficiency. The Quality Lead must provide full ownership of the Quality Management System while remaining operationally hands on in a fast-paced, resource-constrained environment. This role requires a pragmatic pharmaceutical Quality Leader who understands how to embed GMP controls without slowing production, and who can balance compliance with operational excellence. The Quality Lead will serve as the primary customer-facing Quality representative and must be capable of independently assessing risk, leading audits, and driving pharmaceutical discipline within a micro-site. This is not a corporate QA role. This is a hands-on site Quality Owner role.
Key Responsibilities:
Quality System Ownership (Lean, High-Speed Environment)
Own and continuously improve the site QMS (GMP, SOPs, records, forms, templates)
Embed ALCOA+ data integrity principles into daily operations without disrupting line efficiency
Lead internal audits, management review, and quality governance
Personally verify GMP-critical records and processes on the production floor
Build simple, effective quality systems suited to high-speed continuous manufacturing
Regulatory & Customer Interface:
Act as primary Quality contact for customers and regulators
Lead customer audits and inspections end-to-end
Own RCA development and CAPA effectiveness (systemic, risk-based, operationally realistic)
Ensure commitments protect product integrity while supporting production continuity
Risk Management & Compliance:
Hands-on ownership of:
Validation lifecycle (process, cleaning, utilities)
Contamination control strategy
IPC programs aligned to continuous production
Water system oversight
Stability programs
Data integrity governance
Change control and deviations Proactively identify risks before customer escalation while maintaining operational flow.
Manufacturing Quality Oversight (Critical):
Daily floor presence across: Dispensing, Packaging, Laboratory, Production
Direct involvement in problem-solving on running lines •
Ensure GMP-critical equipment maintenance is documented and controlled without unnecessary downtime
Oversee batch release readiness
Challenge legacy practices that do not meet pharmaceutical expectations or lean efficiency targets
Leadership in a Micro, High-Performance Operation:
Lead a small Quality team (QA/QC/Admin)
Coach operators and supervisors on GMP behaviour in a fast-moving environment
Set clear expectations and accountability
Be comfortable operating without layers of support
Balance regulatory compliance with >90% production efficiency targets
Lead cultural reset within the Quality function, improving engagement, retention, and accountability while restoring momentum in a high-pressure, lean operation. This role requires someone who can protect quality while lines are running, not after the fact.