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Senior complaints manager

AssureBio
Complaints manager
Posted: 13 June
Offer 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

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