Senior Manager, Global Quality & Validation

PCI Pharma Services; United Kingdom; On-site; GBP 90,000 - 130,000; Full time

Job summary

PCI Pharma Services seeks a senior leader to oversee Client Quality Account Management and Validation across our UK site. You will lead the Quality Account Manager team, drive GMP-compliant validation, and manage regulatory submissions to support timely product releases.

The role requires strategic thinking, risk management, and robust communication with clients and regulators, ensuring continuous improvement and adherence to quality standards across all activities.

Qualifications

• Bachelor's degree in a related field or equivalent experience.
• Aspire to or be eligible to act as a Qualified Person under 75/319/EC.
• Lean Six Sigma Green Belt or higher is desirable.
• ILM Level 5 or above in management.

Responsibilities

• Provide strategic leadership across Client Quality Account Management and Validation functions.
• Lead and develop the Quality Account Manager team with oversight of client quality requirements and regulatory submissions.
• Oversee qualification and validation activities for processes, equipment, utilities, cleaning and computer systems.
• Act as senior escalation point for complex client, regulatory and quality matters.
• Ensure compliance with GMP and align activities with product quality and business objectives.
• Identify and manage risks affecting delivery, quality, timelines or performance.
• Develop metrics and provide oversight of all areas to support the business.
• Maintain client relationships and ensure quality documentation supports timely product release.
• Review and approve validation protocols, reports and change controls.
• Support audits and inspections from clients and regulators.
• Drive continuous improvement across quality and validation processes.

Skills

Quality leadership

People management

GMP compliance

Quality systems

Regulatory knowledge

Communication skills

Risk management

Quality documentation

Training & development

Audit support

Problem solving

Education

Bachelor's Degree in a related field

Green Belt in Lean or Six Sigma

ILM Level 5 Management Qualification

Qualified Person eligibility (EU/UK)

Tools

GxP documentation tools

Job description

PCI Pharma Services seeks a senior leader to oversee Client Quality Account Management and Validation across our UK site. You will lead the Quality Account Manager team, drive GMP-compliant validation, and manage regulatory submissions to support timely product releases.

The role requires strategic thinking, risk management, and robust communication with clients and regulators, ensuring continuous improvement and adherence to quality standards across all activities.