Head of Quality (PSS08146)

About the Company

An integrated pharmaceutical organization with comprehensive capabilities in API development and manufacturing, finished dosage product development, regulatory affairs, and international markets. The company operates state-of-the-art manufacturing facilities with multiple global GMP certifications and is focused on expanding its global presence and leadership strength in regulated markets.

Position Overview

The Group Quality Head serves as the senior enterprise Quality authority, accountable for establishing and replicating a consistent Quality philosophy, governance framework, and compliance standards across all facilities. This role provides strategic oversight to site Quality Heads, strengthens enterprise QMS and data-integrity governance, and accelerates readiness for international regulated-market approvals while ensuring Quality remains independent, practical, and business-enabling. The position reports directly to the Managing Director.

Key Responsibilities

• Establish Group Quality standards, policies, SOP architecture, and governance across API and formulation operations.
• Ensure site QA, QC, and Microbiology functions operate within a consistent enterprise Quality framework.
• Provide independent Quality oversight for critical decisions, escalations, and integration or replication of Quality standards across new, expanded, and acquired facilities.
• Establish enterprise-level governance, review mechanisms, and trend oversight for site Quality systems, ensuring effective management of deviations, investigations, CAPA, change control, and product quality reviews.
• Define Group expectations for data integrity, documentation governance, qualification/validation strategy, and Quality risk management.
• Own Group-level vendor-quality governance, qualification principles, and Quality risk standards, ensuring consistent application across sites and functions.
• Build sustained organizational readiness for international certifications, inspections, and regulated-market approvals including USFDA, EU, and TGA Australia.
• Provide strategic oversight of inspection preparedness, remediation governance, and cross-site learning from audits and regulatory observations.
• Lead site Quality Heads through governance, reviews, dashboards, and escalation mechanisms.
• Build succession plans, technical capability, and a culture where Quality and data integrity are non-negotiable.

Required Experience & Qualifications

• Education: M.Pharma / M.Sc. or equivalent relevant qualification.
• Experience: 20+ years of progressive pharmaceutical Quality experience, including enterprise/corporate or multi-site Quality leadership in regulated environments.
• Leadership: Proven ability to lead site Quality Heads and influence cross-functional stakeholders at executive levels, reporting to Managing Director.
• Technical Expertise: Deep pharmaceutical Quality leadership background with strong exposure to international regulated markets; USFDA experience preferred, along with EU, TGA Australia, and other global regulatory inspections and approvals. Experience in API and FDF operations and new-site/acquisition Quality integration is advantageous.
• Soft Skills: Integrity-driven, strategic, and committed to placing Quality and data integrity at the center of decision-making.

Why Consider this Opportunity?

• Lead enterprise-wide Quality governance across multiple global manufacturing sites.
• Drive strategic Quality initiatives that enable accelerated international market approvals.
• Shape and embed a unified Group Quality philosophy and compliance culture.
• Influence senior leadership and cross-functional teams in a high-growth, regulated environment.
• Build and mentor a strong Quality leadership pipeline and technical capability.

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