Site Quality Head (Pharma | Life Sciences)

The Site Quality Head provides strategic and operational leadership across Quality Assurance, Quality Control, and Quality Systems within a regulated manufacturing environment. This role is accountable for ensuring full compliance with current Good Manufacturing Practices (cGMP), regulatory standards, and client requirements, while driving a culture of quality, continuous improvement, and inspection readiness.

The position serves as the key authority on all quality-related matters, including batch disposition, regulatory inspections, and quality systems governance, and acts as the primary liaison with regulatory bodies.

Key Responsibilities:

Quality Leadership & Governance

• Lead and oversee end-to-end QA and QC operations, including raw materials, in-process controls, finished product release, microbiological testing, and stability programs.
• Serve as the final authority for batch disposition, including approval or rejection of raw materials, packaging materials, and finished products.
• Establish and maintain a robust Pharmaceutical Quality System (PQS) aligned with global regulatory expectations.

Regulatory Compliance & Inspection Readiness

• Ensure compliance with cGMP, PIC/S, FDA, and other applicable regulatory standards.
• Lead regulatory inspections, client audits, and internal audits; ensure timely closure of audit observations.
• Act as the primary point of contact for regulatory authorities and external auditors.

Quality Systems Management

• Oversee core quality systems including deviations, CAPA, change control, complaints, risk management, and validation.
• Review and approve critical GMP documentation such as validation protocols/reports, SOPs, risk assessments, and investigation reports.
• Ensure effective implementation of data integrity and documentation practices across all quality systems.

Operational Excellence & Continuous Improvement

• Drive continuous improvement initiatives across manufacturing and quality processes to enhance compliance, efficiency, and product quality.
• Provide strategic direction on validation, qualification, and process improvements.
• Ensure effective product lifecycle management including stability and ongoing process verification.

Stakeholder Management

• Collaborate cross-functionally with Production, Engineering, Supply Chain, and Technical Services to ensure alignment on quality standards.
• Manage client communications related to quality concerns, product complaints, and recalls, ensuring timely and compliant resolution.

People Leadership

• Lead, develop, and mentor QA/QC leaders and teams, including Quality Systems, Validation, and Compliance functions.
• Establish training frameworks to ensure organization-wide adherence to cGMP and quality standards.
• Build a high-performance culture focused on accountability, compliance, and continuous learning.

Scope of Responsibility

• Direct oversight of QA, QC, Validation, Quality Systems, and Compliance Heads
• Indirect oversight of laboratory analysts, specialists, and technical personnel

Qualifications:

Education

• Bachelor's Degree in Pharmacy, Chemistry, Chemical Engineering, or related field
• Licensed Pharmacist or Chemist preferred

Experience

• Minimum 10+ years of progressive experience in Quality within pharmaceutical, biotech, or regulated manufacturing
• At least 5 years in a senior leadership or site quality role
• Strong exposure to regulatory inspections (e.g., FDA, PIC/S, EU GMP)

Technical Expertise

• Deep knowledge of cGMP, Pharmaceutical Quality Systems (PQS), and regulatory frameworks
• Strong experience in:
• Batch release and disposition
• Validation and qualification (process, cleaning, equipment)
• Deviation investigation, CAPA, and change control
• Product complaints and recall management
• Supplier qualification and audits
• Data integrity and risk management

Leadership & Competencies

• Strong leadership presence with proven ability to manage cross-functional teams
• High level of accountability and decision-making authority in regulated environments
• Excellent stakeholder management and regulatory communication skills
• Strategic mindset with strong execution capability