Quality Oversight and Compliance Manager

TieTalent; Cotswold District; Remote; GBP 50,000 - 90,000; Full time

Job summary

An established industry player is seeking a Quality Oversight and Compliance Manager to enhance regulatory processes and compliance in a dynamic environment. This role involves driving improvements through data analysis, managing investigations, and collaborating with global teams to ensure inspection readiness and audit preparedness. The ideal candidate will have a strong background in regulatory affairs and project management, with the ability to translate complex data into actionable insights. If you're passionate about quality and compliance in the pharmaceutical sector, this opportunity is perfect for you.

Qualifications

• Experience leading investigations and managing CAPA plans.
• Strong knowledge of drug development and Regulatory Strategy.

Responsibilities

• Identify opportunities for improvement in pan-regulatory data and processes.
• Lead investigations into suspected Quality Events (QEs) and audits.
• Generate metrics and analyze data to support Quality Plans.

Skills

Investigation Management

Regulatory Affairs

Project Management

Data Analysis

Change Management

Education

Sc., M.S., Ph.D. or equivalent

Tools

Electronic Regulatory Systems

Job description

Quality Oversight and Compliance Manager

Location: Remote with occasional travel to Walton Oaks or Sandwich

Contract: 6 Months

Job Description:

SRG is seeking a Quality Oversight and Compliance Manager for a global pharmaceutical company. The role involves driving improvements to existing processes, supporting implementation and monitoring of initiatives related to pan-regulatory information and processes (e.g., Manufacturing, Regulatory Strategy, CMC, Submissions, Translation) globally through data reporting and metrics analysis. The manager will collaborate with global delivery teams to enhance quality and compliance related to regulatory processes and product/license information.

The manager will work closely with the SPACE teams and other stakeholders to identify procedural and compliance gaps, establish and monitor remediation plans, and support initiatives to improve inspection readiness, audit preparedness, and training compliance. Additionally, they will lead investigations involving process or data deviations and support data gathering, metrics generation, and analysis for Quality Plans and compliance initiatives.

Responsibilities:

1. Identify opportunities for improvement in pan-regulatory data and processes through metric data analysis in collaboration with relevant teams and stakeholders.
2. Provide detailed reports and presentations for senior management, Quality councils, and governance committees, including executive summaries.
3. Identify procedural and compliance gaps, establishing mitigation and remediation plans with process owners to balance compliance and business needs.
4. Support stakeholders in inspection readiness, audit preparation, and remediation of audit findings.
5. Participate in cross-functional teams to implement quality improvements.
6. Lead investigations into suspected Quality Events (QEs), CAPA plans, and audits/inspections, owning associated actions.
7. Generate metrics and analyze data to support Quality Plans and compliance initiatives.

Experience and Qualifications:

• Experience leading investigations and managing CAPA plans.
• Strong knowledge of drug development, Regulatory Affairs, Regulatory Strategy, and Submissions Management.
• Proficiency in project management and adaptability within dynamic environments.
• Understanding of systems and electronic technologies supporting regulatory and submission processes.
• Ability to translate data into actionable information for decision-making.
• Skill in transforming ambiguous situations into structured outcomes.
• Experience managing change and influencing colleagues across organizations.
• Proven project management aptitude.

Qualifications:

• Sc., M.S., Ph.D., or equivalent.
• Knowledge of pharmaceutical company structures, policies, and global regulatory strategies.
• Strong interpersonal, analytical, organizational, and communication skills.

Carbon60, Lorien & SRG - The Impellam Group STEM Portfolio act as an employment business regarding this vacancy.