Senior Compliance and Quality Assurance Consultant - Permanent position

About the role

ProPharma Group is a consulting firm with 25 years’ experience that advises biotech, medical device and pharmaceutical organisations across the complete product lifecycle using an advise-build-operate model.

The Senior Compliance and Quality Assurance (Qualified Person) Consultant will support life-science clients through development and commercialisation phases, providing strategic development, project leadership and SME support in QA; the role offers exposure to diverse therapeutic projects and remote working options, plus a competitive remuneration package and work-life balance.

Responsibilities

• Act as a key Subject Matter Expert in quality assurance and regulatory/GxP, providing independent consultation and leading client projects including QP batch certification, GxP auditing and QMS development.
• Identify scope and effort for client engagements, promote CQA services, drive continual improvement in customer satisfaction and deliver CQA-specific training.
• Support clients and internal units on GxP issues, consult on CAPA implementation, contribute to SOP writing and training, and educate employees to drive continuous improvement.
• Perform Qualified or Responsible Person functions for clients as applicable and contribute to phase-appropriate, risk-based GxP project execution while keeping pace with regulatory and technological changes.
• Undertake other duties as assigned.

Requirements

• Education: Ideally a BSc level in Pharmacy or another appropriate discipline.
• Experience: Minimum 10 years experience in Quality Assurance within GxP settings.
• Qualified Person experience: 2–3 years or more working as a Qualified Person.
• Experience with development and marketed products is desirable.
• Regulatory knowledge: thorough understanding of US FDA, ICH, EMA and MHRA expectations.
• Language and skills: fluency in English (and ideally one other EU language), demonstrated project management skills, and strong collaboration and stakeholder management abilities.

Preferred qualifications

Preferred: BSc in Pharmacy (or similar), experience with development and marketed products, and proficiency in an additional EU language.

Skills

• Project management, prioritisation, collaboration and stakeholder engagement skills.
• Subject-matter expertise in quality assurance and regulatory/GxP.

Work arrangement

Remote-first option with support for hybrid working for new hires living within a reasonably short commute of an office; specific arrangements to be agreed with the manager.

Compensation

ProPharma offers a competitive remuneration package and aims to support a positive work-life balance.

Benefits

Project variety across therapeutic areas; remote and hybrid work options; personal review of applications without AI screening; commitment to provide applicants with an outcome.

Company context

ProPharma has 25 years’ experience advising biotech, med device and pharmaceutical organisations and offers end-to-end, customizable consulting solutions across regulatory sciences, clinical research, quality & compliance, pharmacovigilance, medical information and R&D technology.

Relevant source disclaimer

Diversity & inclusion statement: We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.

Application process: All applications are personally reviewed by recruitment; no AI screening tools are used; applicants will always receive an outcome.

Additional application notes: ProPharma supports remote working but encourages hybrid working for those near an office; applications are treated on their own merit regardless of proximity to an office. ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please do not call or email regarding this posting.