Overview
A world renowned CDMO, focused on supporting a mixture of small biotech's through to leading Pharmaceutical companies. They have development and commercial focuses for international clients.
The Quality compliance lead is responsible for ensuring the ongoing quality, compliance, and lifecycle management of assigned pharmaceutical products. Acting as the quality representative for the product, this role partners closely with Manufacturing, QC, QA, Supply Chain, and Regulatory Affairs to ensure products consistently meet GMP, regulatory, and company quality standards. You will act as lead auditor, working with health authorities in a front office facing role, leading inspections and answering questions and or challenges.
Key Responsibilities
* Act as Quality Lead for both internal and external Audits and Inspections.
* Main POC for Health Authority inspections and customer Audits.
* Liaise with customers, and answer concerns and queries, as well as offer advice.
* Act as the primary quality point of contact for assigned products
* Review, assess, and approve deviations, CAPAs, change controls, and risk assessments related to the product
* Support batch release activities, including review of manufacturing and QC documentation.
Required Qualifications & Experience
* Degree in Life Sciences, Pharmacy, Chemistry, or a related field
* Experience in pharmaceutical or biotech quality roles (QA, QC, or Product Quality)
* Audit experience, and work with any health authorities/regulatory bodies.
* Strong working knowledge of GMP and pharmaceutical quality systems
* Experience handling deviations, CAPAs, change control, and documentation review
* Ability to work cross-functional in a fast-paced, regulated environment
* Strong analytical, organisational, and communication skills
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