Lead Qualified Person

AssureBio; Greater London; On-site; GBP 120,000 - 160,000; Full time

Job summary

An established industry player in the pharmaceutical sector is seeking a Lead Qualified Person to oversee quality management in radiopharmaceutical manufacturing. This pivotal role involves managing a team of Qualified Persons, ensuring compliance with GMP standards, and mentoring quality teams to foster a culture of continuous improvement. The successful candidate will play a key role in the safe release of products across multiple sites in the UK, contributing to the enhancement of the Global Quality System. If you're ready to take your career to the next level in a dynamic environment, this is the opportunity for you.

Qualifications

• Eligible to be named as a Qualified Person (QP) on a manufacturing licence.
• 10+ years’ Quality Assurance experience within a UK-licensed pharmaceutical organisation.
• 5+ years’ experience managing Quality teams in QA or QC.
• Previous experience in QP certification of medicinal products.
• Background in pharmaceutical manufacturing, preferably sterile or radiopharmaceutical production.

Responsibilities

• Manage and lead a team of Qualified Persons across multiple UK manufacturing sites.
• Ensure compliance with GMP, UK/EU regulations, and local/global procedures.
• Chair the QP Forum and contribute to site Quality Management Meetings.
• Ensure GMP compliance with UK/EU regulations and procedures.
• Review and certify batches; oversee deviations, CAPAs, and OOS/OOT investigations.
• Support MHRA inspections at key manufacturing sites.
• Mentor and coach quality teams to foster a culture of compliance and continuous improvement.
• Collaborate with Head of Quality to enhance the Global Quality System.

Skills

Quality Assurance

GMP Compliance

Team Leadership

Mentoring

Regulatory Compliance

Education

Qualified Person (QP) Certification

10+ years in Quality Assurance

Background in Pharmaceutical Manufacturing

Job description

Are you an experienced Qualified Person (QP) looking to take the next step in your career?

Do you thrive in leadership roles where you can shape quality strategy, mentor teams, and ensure the highest standards of GMP compliance?

We are recruiting for a Lead Qualified Person to take on a leadership role within a dynamic pharmaceutical environment, overseeing a team of QPs and quality management in radiopharmaceutical manufacturing.

About the Role

As a Lead QP, you will play a critical role in ensuring the safe release of radiopharmaceutical products across multiple sites in the UK. You will be responsible for:

• Managing and leading a team of permanent and contract Qualified Persons (QPs) across multiple UK manufacturing sites.
• Acting as a Releasing QP for radiopharmaceuticals/sterile products under a UK MHRA licence.
• Chairing the QP Forum and contributing to site Quality Management Meetings.
• Ensuring compliance with GMP, UK/EU regulations, and local/global procedures.
• Reviewing and certifying batches in a timely manner while overseeing deviations, complaints, CAPAs, and OOS/OOT investigations.
• Supporting MHRA inspections at key manufacturing sites.
• Acting as a mentor and coach for quality teams, fostering a culture of compliance and continuous improvement.
• Working closely with the Head of Quality to enhance and maintain the Global Quality System.

Experience & Qualifications

• Eligible to be named as a Qualified Person (QP) on a manufacturing licence.
• 10+ years’ Quality Assurance experience within a UK-licensed pharmaceutical organisation.
• 5+ years’ experience managing Quality teams in Quality Assurance or Quality Control.
• Previous experience in QP certification of medicinal products.
• Background in pharmaceutical manufacturing, preferably in sterile or radiopharmaceutical production.

Seniority Level

Mid-Senior level

Employment Type

Full-time

Job Function

Quality Assurance

Industries

Pharmaceutical Manufacturing