Quality Oversight and Compliance Manager

JR United Kingdom; United Kingdom; Remote; GBP 40,000 - 80,000; Full time

Job summary

An established industry player is seeking a Quality Oversight and Compliance Manager to enhance regulatory processes and ensure compliance in a dynamic environment. This role involves collaborating with global teams to drive continuous improvement, preparing insightful reports for leadership, and leading investigations into Quality Events. The ideal candidate will possess strong project management skills and the ability to interpret complex data into actionable insights. Join a forward-thinking organization that values diversity and innovation in the pharmaceutical sector.

Qualifications

• Experience in leading investigations and managing CAPAs.
• Knowledge of drug development and regulatory strategy.

Responsibilities

• Identify improvement opportunities in regulatory processes.
• Prepare data-driven reports for senior leadership.
• Support audit readiness and remediation efforts.

Skills

Investigation Management

CAPA Management

Regulatory Affairs Knowledge

Project Management

Data Analysis

Change Management

Communication Skills

Education

B.Sc. in a relevant field

M.Sc. or Ph.D. in a relevant field

Tools

Regulatory and Submission Systems

Job description

Job Title: Quality Oversight and Compliance Manager

Location: Sandwich, Walton Oaks, or Remote (with occasional office visits)

Duration: 6 Months

Work Type: Remote

Overview:

TekWissen is a global workforce management provider operating throughout the UK, Europe, and other countries. The client is an American multinational pharmaceutical and biotechnology corporation.

Job Description:

Position Overview

• The Quality Oversight and Compliance Manager will drive continuous improvement in regulatory processes, collaborating with global teams such as Regulatory Strategy, Global CMC, Regulatory Operations, Safety, and Information Management to enhance quality and compliance of regulatory data and processes. Responsibilities include audit readiness, quality planning, and metrics-driven decision making.

Key Responsibilities

• Identify improvement opportunities in pan-regulatory processes through metrics analysis and stakeholder collaboration.
• Prepare clear, data-driven reports and summaries for senior leadership and governance bodies.
• Identify procedural and compliance gaps; develop and implement remediation plans.
• Support audit and inspection readiness and remediation efforts.
• Lead or support investigations of Quality Events (QEs), develop CAPA plans, and assist in audits/inspections.
• Engage in cross-functional initiatives to improve quality.
• Create metrics and conduct analyses to support Quality Plans and compliance tracking.

Technical Skills & Experience Required

• Experience leading investigations and managing CAPAs.
• Knowledge of drug development, Regulatory Affairs, Regulatory Strategy, and Submissions Management.
• Proficiency in project management and adaptability in dynamic environments.
• Familiarity with regulatory and submission systems and technologies.
• Ability to interpret complex data into actionable insights.
• Change management skills and influence across matrix organizations.
• Ability to handle ambiguity and produce structured outcomes.
• Strong communication and interpersonal skills for cross-functional leadership.

Preferred Qualifications

• B.Sc., M.Sc., Ph.D., or equivalent in a relevant field.
• Experience in a global pharmaceutical environment with regional regulatory strategies.
• Proven project management skills for complex, evolving projects.
• Strong analytical, organizational, and problem-solving skills.
• Excellent written and verbal communication skills.

TekWissen Group is an equal opportunity employer supporting workforce diversity.