Job Description
Clinical Development QA Manager
Essential Pharma is seeking a Clinical Development QA Manager responsible for identifying and mitigating quality and compliance risks in all aspects of clinical studies. The role requires adherence to GCP, GLP, GCLP, GMP, GDP, and GPvP regulations, along with leading site audits and inspections. Apply today!
What You Will Do
* Maintain and develop a quality strategy aligned with clinical development needs.
* Establish and oversee a quality management system supporting clinical activities.
* Develop SOPs to ensure best practices in clinical trial processes.
* Coordinate audits of clinical sites, CROs, manufacturers, and laboratories.
* Manage the annual audit schedule and CAPA system.
* Prepare and review documentation for regulatory submissions.
* Develop and maintain quality procedures, training matrices, and documentation control.
* Ensure readiness for regulatory inspections.
* Collaborate with project teams to ensure compliance with ICH guidelines and regulations.
* Provide regular quality updates to senior management.
* Stay informed on regulatory trends and share insights.
* Manage CAPA activities and monitor their closure.
* Maintain awareness of relevant regulatory guidelines across territories.
About Us
Essential Pharma is an international specialty pharmaceutical company focusing on niche medicines for small patient populations. Our portfolio includes over 300 medicines across various therapeutic areas, treating patients in over 70 countries. We focus on low-volume, difficult-to-manufacture products and late-stage clinical assets, including our recent acquisition of Renaissance Pharmaceuticals. In December 2024, we announced a €900 million recapitalisation with partners Gyrus Capital, AlpInvest, and Sixth Street. Our team comprises around 70 employees based in Surrey UK, Malta, France, Spain, and Switzerland.
What You Will Bring
* A degree in life sciences, pharmacy, chemistry, or an equivalent qualification.
* At least 5 years of GCP QA experience and thorough knowledge of GMP.
* Experience in building and maintaining a QMS supporting clinical trials in a biotech setting.
* Significant experience in QA roles within clinical development, such as CRO or sponsor environments.
* Deep understanding of GxP, especially GCP, GMP, and GLP.
What We Offer
* Competitive salary and benefits.
* Hybrid working model with flexibility for remote and office work.
* £150 home office allowance.
* Healthcare insurance, pension scheme, life insurance, enhanced family leave, sick pay, and 26 days of annual leave.
* Discretionary performance bonus.
What To Expect
* An inclusive, agile, and values-driven workplace culture that encourages authenticity and connection.
* Opportunities for growth, learning, and engaging with leadership.
* An environment that values autonomy, responsibility, and collaboration.
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