GCP Compliance & QA Consultant (Pharma)
Мэтч & Сопровод
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Описание вакансии
TL;DR
GCP Compliance & QA Consultant (Pharma): Providing expert regulatory and quality assurance consulting for biotech and pharmaceutical clients with an accent on GxP compliance, auditing, and QMS development. Focus on managing complex regulatory projects, ensuring adherence to FDA/EMA/MHRA standards, and driving continuous quality improvement across the product lifecycle.
Location: Remote/Hybrid (US, UK, and EU)
Company
is a global consulting firm providing end-to-end regulatory, clinical, and quality solutions for the life sciences industry.
What you will do
- Represent the company in quality assurance and regulatory GxP matters.
- Provide expert consultation and project management within the CQA business practice.
- Execute risk-based GxP projects and support client needs through the sales process.
- Develop and implement quality systems, including SOP writing and training.
- Support clients in resolving deviations and non-conformances through CAPA implementation.
- Promote CQA services through content development and client training.
Requirements
- Bachelor’s degree in a scientific discipline required (MSc/PhD preferred).
- Minimum 5 years of relevant experience in quality assurance and regulatory GxP compliance.
- Strong knowledge of US FDA, ICH, EMA, and MHRA regulations.
- Recent auditing experience (at least 5 audits in the past year for audit-focused roles).
- Professional proficiency in English (additional European language preferred for EU-based roles).
- Ability to travel as required for client projects.
Culture & Benefits
- Commitment to diversity, equity, and inclusion.
- Supportive environment for innovative and entrepreneurial professionals.
- Hybrid work model encouraged for those near office locations.
- Opportunities for professional growth in a global consulting environment.
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