Client Quality, Technical & Validation Lead

PCI TRGR Penn Pharmaceutical Services Ltd; Tredegar; On-site; GBP 90,000 - 130,000; Full time

Job summary

PCI Pharma Services in Tredegar is seeking a senior Quality leader to oversee Client Quality Account Management and Validation. You will lead teams, manage regulatory submissions, and ensure GMP-compliant quality activities across projects.

The role focuses on risk-based validation, change controls, and maintaining strong client relationships to support timely product Release and continuous quality improvements.

Qualifications

• Extensive experience in a Quality function within a pharmaceutical company.
• Strong regulatory and GMP knowledge with proven QA leadership.
• Ability to lead and develop multiple teams and manage client quality requirements.

Responsibilities

• Provide strategic leadership across Client Quality Account Management and Validation.
• Lead QA teams, ensuring oversight of regulatory submissions, Quality Agreements and change controls.
• Drive risk-based validation programmes and ensure timely product release.
• Liaise with regulatory audits and inspections and maintain robust quality documentation.

Skills

Quality leadership

Regulatory knowledge

Quality Assurance

GMP compliance

Risk management

Stakeholder management

Education

Bachelor's Degree in related field

QP eligibility (75/319/EC)

Tools

GxP systems

Documentation management

Job description

PCI Pharma Services in Tredegar is seeking a senior Quality leader to oversee Client Quality Account Management and Validation. You will lead teams, manage regulatory submissions, and ensure GMP-compliant quality activities across projects.

The role focuses on risk-based validation, change controls, and maintaining strong client relationships to support timely product Release and continuous quality improvements.