Senior Quality Associate – 6-Month Contract (with possibility of extension)
Location: Bracknell (Hybrid)
Company: Our client is a global pharmaceutical organisation focused on developing and delivering innovative medicines that improve patient outcomes worldwide. Operating across multiple therapeutic areas,.
We are seeking an experienced Senior Quality Associate to support the implementation and oversight of quality systems and compliance activities across regional business operations. This role will work closely with cross-functional teams to ensure alignment between global quality standards and local regulatory requirements within a regulated pharmaceutical environment.
Key Responsibilities
Quality Systems Management
* Support the development, review, and maintenance of regional quality system documentation, procedures, and templates.
* Provide guidance on regulatory requirements, quality standards, and business process compliance.
* Manage deviations, change controls, notifications to management (NTMs), and CAPA activities.
* Conduct root cause investigations and support implementation of corrective and preventive actions.
* Ensure effective application of enterprise quality systems and continuous compliance across the business.
* Participate in quality self-assessments and external party oversight activities.
Quality Oversight & Compliance
* Monitor compliance with quality procedures and proactively identify process improvements and risk mitigation opportunities.
* Support implementation and tracking of regional quality plans and compliance actions.
* Analyse quality trends, identify gaps, and recommend corrective actions where required.
* Provide input into risk assessments, audit planning, and quality improvement initiatives.
* Drive continuous improvement and promote best practices across teams and functions.
Audits & Inspections
* Coordinate and support audit and inspection readiness activities, including document preparation and stakeholder coordination.
* Manage audit responses and ensure timely completion of CAPA actions arising from inspections or audits.
* Support front room/back room activities during regulatory inspections.
Cross-Functional Collaboration
* Act as a key quality contact for assigned business areas.
* Partner with stakeholders to strengthen quality controls and compliance processes.
* Collaborate with global and regional quality teams to share knowledge and improve operational effectiveness.
* Contribute to business and quality-related projects as required.
Required Experience & Qualifications
* Bachelor’s or Master’s degree in a science or healthcare-related discipline.
* Previous experience within Quality, Regulatory Affairs, Clinical Development, Pharmacovigilance, or related GxP environments.
* Strong understanding of GMP, GCP, GVP, CAPA, deviations, and change control processes.
* Experience supporting audits and regulatory inspections.
* Excellent communication, analytical, and problem-solving skills.
* Ability to manage multiple priorities within a fast-paced, regulated environment.
* Experience working within global or cross-functional teams is advantageous.