Quality Assurance Manager

JR United Kingdom; Stone Cross; On-site; GBP 45,000 - 75,000; Full time

Job summary

An established industry player is seeking a Quality Oversight and Compliance Manager to drive improvements in regulatory processes. This role involves collaborating with global teams to enhance compliance and quality through data reporting and metrics analysis. You will identify gaps in procedures, support stakeholders in audit readiness, and lead investigations into quality events. If you have a strong background in regulatory affairs and a passion for quality management, this is an exciting opportunity to make a significant impact in a dynamic environment.

Qualifications

• Experience in leading CAPA plans and investigations.
• Strong understanding of drug development and regulatory submissions.

Responsibilities

• Identify opportunities for improving data and business processes.
• Prepare reports for senior management and governance committees.
• Support stakeholders in audit preparation and inspection readiness.

Skills

Investigation Leadership

Regulatory Affairs Knowledge

Project Management

Data Analysis

Stakeholder Management

Education

Bachelor's Degree in Life Sciences

Relevant Certifications in Quality Management

Tools

Quality Management Systems

Data Reporting Tools

Job description

Social network you want to login/join with:

I am looking to speak with Quality & Compliance Managers seeking their next contract opportunity with a Global Pharmaceutical Manufacturing organization based in Sandwich, Kent.

This position reports to the Regulatory Quality Oversight Lead for Submission Process & Compliance Excellence, Submissions Management, and collaborates with GRS BU Regulatory Strategy (above country and in-country), Global CMC, Regulatory Operations, Safety and Regulatory Quality, Information Management, COE SOP & Training, governance bodies, and external vendors if applicable.

Position Purpose

The Quality Oversight and Compliance Manager will drive improvements to existing processes, support the implementation and monitoring of initiatives related to pan-regulatory (e.g., Manufacturing, Regulatory Strategy, CMC, Submissions, Translation) information and processes globally through data reporting and metrics analysis. The role involves working with global teams to enhance the quality and compliance of regulatory processes and product/license information.

Primary Responsibilities

1. Identify opportunities for improving pan-regulatory data and business processes by analyzing metrics data in collaboration with Information Management, Analytics + Reporting, process owners, and stakeholders.
2. Prepare accurate reports and presentations on these activities for senior management, Quality councils, and governance committees, including executive summaries.
3. Identify procedural and compliance gaps within scope processes and develop mitigation and remediation plans with process owners to balance compliance and business needs.
4. Support stakeholders in inspection readiness, audit preparation, and provide remediation support for audit or inspection findings.
5. Participate in cross-functional teams to execute quality improvements.
6. Lead or contribute to investigations of suspected Quality Events (QEs), CAPA plans, audits, and inspections, owning actions as appropriate.
7. Generate metrics and analyze data to support Quality Plans and compliance initiatives.

Technical Skill Requirements

1. Experience leading investigations and managing CAPA plans.
2. Strong knowledge of drug development, Regulatory Affairs, Regulatory Strategy, and Submissions Management.
3. Proficiency in soft skills and adaptability of project management within dynamic environments.
4. Understanding of systems and electronic technologies supporting regulatory and submission processes, including process development and new technology implementation.
5. Ability to translate data into actionable information for decision-making and to structure ambiguous situations.
6. Experience managing change with stakeholders.
7. Ability to lead and influence colleagues across the organization to deliver complex projects on time and with quality.