Quality Oversight and Compliance Manager

Job Title: Quality Oversight and Compliance Manager

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

Duration: 6 Months

WorkType : Remote

Pay Rate: £32/hr umbrella or £150/day Take home

Overview:

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

Job Description:

Position Overview

• The Quality Oversight and Compliance Manager will play a pivotal role in driving continuous improvement across regulatory processes. This individual will collaborate with cross-functional global teams—including Regulatory Strategy, Global CMC, Regulatory Operations, Safety, Information Management, and more—to enhance quality and compliance related to regulatory data and processes. The role involves deep engagement in audit readiness, quality planning, and metrics-driven decision making.

Key Responsibilities

• Identify improvement opportunities across pan-regulatory processes by analyzing metrics and collaborating with stakeholders.
• Deliver clear, data-driven reports and executive summaries to senior leadership and governance bodies.
• Recognize procedural and compliance gaps; implement balanced remediation plans.
• Support audit/inspection readiness and remediation efforts.
• Lead or support investigations of Quality Events (QEs), develop Corrective/Preventative Action (CAPA) plans, and contribute to audits/inspections.
• Participate in cross-functional initiatives targeting quality enhancements.
• Develop metrics and conduct analyses to support Quality Plans and compliance tracking.

Technical Skills & Experience Required

• Demonstrated experience in leading investigations and managing CAPAs.
• In-depth knowledge of the drug development process, Regulatory Affairs, Regulatory Strategy, and Submissions Management.
• Proficient in project management with the ability to adapt and lead in dynamic environments.
• Familiarity with systems and technologies used in regulatory and submission processes.
• Ability to translate complex data into actionable insights.
• Skilled in change management and influencing across matrix organizations.
• Capable of handling ambiguity and delivering 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 exposure to regulatory strategies across multiple regions.
• Proven ability to manage complex projects with evolving requirements.
• Strong analytical, organizational, and problem-solving capabilities.
• Excellent written and verbal communication skills.

TekWissen® Group is an equal opportunity employer supporting workforce diversity.