Quality Oversight & Compliance Manager

CK Group- Science, Clinical and Technical; Stone Cross; Hybrid; GBP 60,000 - 80,000; Full time

Job summary

An established industry player is seeking a Quality Oversight and Compliance Manager to enhance regulatory processes in the pharmaceutical sector. This role involves driving compliance improvements, managing CAPA plans, and ensuring inspection readiness. The ideal candidate will have a strong background in regulatory affairs and project management, along with the ability to translate complex data into actionable insights. Join a forward-thinking company dedicated to improving lives through innovative biopharmaceutical solutions. This position offers flexibility in location, with options for remote work.

Qualifications

• Experience in leading investigations and managing CAPA plans.
• Strong knowledge of drug development and regulatory processes.

Responsibilities

• Drive improvements to existing processes and ensure compliance.
• Support implementation of initiatives related to regulatory information.

Skills

Regulatory Affairs

Project Management

Data Analysis

CAPA Management

Change Management

Education

Degree in Life Sciences

Certification in Regulatory Affairs

Tools

Electronic Regulatory Systems

Data Reporting Tools

Job description

CK Group are recruiting for a Quality Oversight and Compliance Manager to join a company in the pharmaceutical industry on a contract basis for 6 months initially.

Salary:

PAYE 23.39 - 28.59 per hour or UMB 26.21 - 32 per hour (inside IR35).

Quality Oversight & Compliance Manager role:

• Responsible for driving improvements to existing processes
• Supports implementation and monitoring of initiatives related to pan-regulatory (e.g. Manufacturing, Regulatory Strategy, CMC, Submissions, Translation) information and processes globally through data reporting/metrics analysis.
• Works with global delivery teams to improve the quality and compliance associated with regulatory processes and product/license information
• Identifies procedural/compliance gaps and establish and monitor remediation plans to close identified gaps
• Supports and drives implementation of initiatives targeting improvements in inspection readiness, audit preparedness and training compliance

Your Background:

• Experience in leading investigations and managing CAPA plans
  
  
• Strong knowledge of the drug development process, Regulatory Affairs, Regulatory Strategy and Submissions Management.
  
  
• Proven fluency with use of soft skills and ability to adapt core project management skills successfully within a dynamic line environment.
  
  
• Understanding of systems and electronic technologies used to support regulatory and submission process and planning activities and experience in process development and new technology implementation.
  
  
• Translates data into information to support the business in taking action and decision making
  
  
• Management of change in partnership with key stakeholders
• Ability to lead and operate seamlessly to influence colleagues across the organization and ensure delivery to time and quality driving highly complex projects to meet evolving business needs.
  
  
• Proven aptitude in project management
  
  

Company:

Our client is one of the world's premier innovative biopharmaceutical companies, discovering, developing and providing over 160 different medicines, vaccines and consumer healthcare products to help improve the lives of millions of people in the UK and around the world every year.

Location:

This role can be based at our clients sites in Sandwich, Kent or Tadworth, Surrey or worked remotely.

Apply:

For more information, or to apply for this Quality Oversight & Compliance Manager role please contact the Key Accounts Team on (phone number removed) or email (url removed). Please quote reference (Apply online only) .

It is essential that applicants hold entitlement to work in the UK

Please note: This role may be subject to a satisfactory basic Disclosure and Barring Service (DBS) check.