QA Manager

TieTalent; Port Talbot; On-site; GBP 60,000 - 80,000; Full time

Job summary

A leading pharmaceutical company based in Port Talbot, Wales, is seeking a QA Manager. The ideal candidate will have extensive experience in GMP life science manufacturing and proficiency in Quality Management Systems. The role involves overseeing the QA team, implementing quality standards, and ensuring regulatory compliance, fostering a culture of continuous improvement within the organization.

Qualifications

• Manufacturing experience with strong QA background within a GMP environment.
• Proficiency in Quality Management Systems, preferably PQS.
• Experience working with MHRA, FDA, or EMA.

Responsibilities

• Oversee the QA team and lead cross-functional QA activities.
• Develop and implement the company's QMS in line with relevant regulations.
• Conduct risk assessments and prepare SOPs, work instructions, and records.

Skills

GMP life science manufacturing

Quality Management Systems

Leadership experience

Communication skills

Education

Qualification in Science (Chemistry, Pharmacy, Biology)

Job description

About the Job:

We require a QA Manager with extensive experience in GMP life science manufacturing, ideally within a pharmaceutical environment, with exposure to drug manufacturing, aseptic filling, packaging, or site services equipment. The role involves working as the QA SME, promoting a strong GMP culture within a small team of QA Officers, and fostering continuous improvement and audit readiness.

Responsibilities:

1. Oversee the QA team, report to the head of department, and lead cross-functional QA activities to meet quality objectives.
2. Develop and implement the company's QMS in line with ISO 9001, ICH Q10, UK Human Medicines Regulations, the Orange Guide, and EudraLex.
3. Conduct risk assessments, audits (internal & external), and prepare SOPs, work instructions, and records.
4. Communicate effectively with regulatory bodies, external suppliers, and senior management.
5. Promote a culture of continuous improvement and ensure audit readiness across departments.
6. Encourage innovative suggestions and challenge existing procedures to support a growing team.

About You:

• Qualification in Science (Chemistry, Pharmacy, Biology, etc.), Engineering, or equivalent.
• Manufacturing experience with strong QA background within a GMP environment.
• Proficiency in Quality Management Systems, preferably PQS.
• Experience working with MHRA, FDA, or EMA.
• Previous leadership or management experience.
• Positive attitude with a drive for continuous improvement.
• Excellent communication skills.

This position is based in Port Talbot, Wales, United Kingdom.