Senior Process Quality Excellence Specialist

Hyper Recruitment Solutions; Greater London; On-site; GBP 50,000 - 70,000; Full time

Job summary

A leading organisation in the pharmaceutical industry is seeking a Senior Process Quality Excellence Specialist for a 12-month contract based in the Berkshire area. This role involves managing regulatory intelligence requirements, coordinating with Subject Matter Experts (SMEs), ensuring compliance with regulatory standards, and overseeing internal Quality Audits. Candidates must have a relevant scientific degree and proven experience in regulatory intelligence and quality management. This is a mid-senior level contract position.

Qualifications

• Proven industry experience in regulatory intelligence and quality management within the pharmaceutical sector.
• Working knowledge and practical experience with audit coordination and regulatory compliance.

Responsibilities

• Act as the RIN coordinator to ensure regulatory requirements are met.
• Review regulations and identify appropriate SMEs for compliance.
• Serve as a contact for CROs regarding regulatory assessments.
• Coordinate internal Quality Audits and manage post-audit responses.

Skills

Regulatory Intelligence

Quality Management

Audit Coordination

Regulatory Compliance

Education

Relevant degree in a scientific or regulatory discipline

Job description

Senior Process Quality Excellence Specialist

A leading organisation in the pharmaceutical industry is seeking a Senior Process Quality Excellence Specialist for a 12‑month contract based in the Berkshire area. As the Senior Process Quality Excellence Specialist, you will play a crucial role in managing Regulatory Intelligence requirements.

Key Duties And Responsibilities

• Act as the RIN coordinator, collaborating with Subject Matter Experts (SMEs) to ensure regulatory and guidance requirements are met in controlled documents.
• Review regulations and identify appropriate SMEs based on the topic, ensuring compliance with regulatory standards.
• Serve as a point of contact to confirm that Contract Research Organisations (CROs) have assessed regulatory and country‑specific regulations impacting their Standard Operating Procedures (SOPs) and company studies.
• Work with the Auditing team to host and coordinate internal Quality Audits, assisting SMEs in responding to audit queries, managing post‑audit responses, and implementing Corrective and Preventive Actions (CAPAs).

Role Requirements

• Relevant degree in a scientific or regulatory discipline.
• Proven industry experience in regulatory intelligence and quality management within the pharmaceutical sector.
• Working knowledge and practical experience with audit coordination and regulatory compliance.

Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer. We welcome applications from anyone who meets the role requirements.

Seniority Level

• Mid‑Senior level

Employment Type

• Contract

Job Function

• Management and Manufacturing
• Industries: Biotechnology Research and Pharmaceutical Manufacturing