Quality Lead

SUMMARY:
Quality Lead required to act as the accountable Quality Authority (hands-on role) for a lean pharmaceutical manufacturing site operating high-speed, continuous production lines at >90% efficiency.  A relevant BSc / BPharm / Btech or equivalent in Life Sciences, Chemistry or Pharmacy is required combined with a min of 8 to 10 years' pharmaceutical manufacturing Quality experience (3+ years in site Quality Leadership).

POSITION INFO:
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.

• 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.

• 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

• 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.

• 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.

• Minimum 8–10 years pharmaceutical manufacturing Quality experience.
• At least 3–5 years in site Quality leadership.

• Proven experience in:
• Lean or small pharmaceutical manufacturing environments
• High-speed continuous production operations
• Sites operating at >85–90% efficiency targets

• Demonstrated ownership of:
• GMP systems
• ALCOA+ data integrity
• Validation lifecycle
• CAPA management
• Customer and/or regulatory audits

• Cosmetics-only, food-only, or ISO-only backgrounds are not acceptable.
• Large corporate QA profiles without hands-on site ownership experience are not suitable.

• GMP compliance
• Process C cleaning validation
• Contamination control
• Risk assessments
• Deviations C CAPA
• Water systems
• IPC in continuous manufacturing
• Stability programs
• Preventive maintenance frameworks

• Must demonstrate:
• Hands-on leadership.
• Independent judgement.
• Comfort challenging operations and engineering.
• Ownership mindset (“my system, my risk”).
• Customer-facing confidence.
• Ability to lead under audit pressure.
• Zero tolerance for undocumented practices.
• Ability to operate at speed without compromising compliance Builder mentality — not caretaker.

• BSc / BPharm / BTech or equivalent in Life Sciences, Chemistry, Pharmacy, or related field
• Formal GMP training essential.

• Quality risks identified internally before customer escalation.
• Audits anticipated, not reacted to.
• Validation and contamination control embedded into daily production.
• CAPAs systemic and operationally realistic.
• Quality visible daily on the floor.
• Lean site running at >90% efficiency with pharmaceutical discipline.