обновлено 2 месяца назад
Senior Compliance & Quality Assurance (Qualified Person) Consultant - Permanent opportunity
Вакансия из Hirify Global, списка международных tech-компанийДля мэтча и отклика нужен Plus
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Senior Compliance & Quality Assurance (Qualified Person) Consultant (Pharmaceutical and Biological Industry): Supporting life science clients through GxP quality assurance, regulatory compliance, Qualified Person activities, and project leadership with an accent on QP batch certification, GxP auditing, and quality management systems. Focus on leading MIA/WDA projects, implementing CAPA for deviations and non-conformances, and developing risk-based, phase-appropriate quality processes.
Location: Sweden; remote working is available, with hybrid work encouraged for employees within a reasonably short commute of an office.
Company
provides consulting solutions across the pharmaceutical, biotechnology, medical device, regulatory, clinical research, quality, compliance, pharmacovigilance, and R&D technology lifecycle.
What you will do
- Provide subject-matter expertise and independent consultation in quality assurance, regulatory compliance, and GxP.
- Lead client projects involving MIA/WDA, PPG MIA licensing, QP batch certification, GxP audits, and quality management systems.
- Act as Qualified or Responsible Person for clients where applicable.
- Support risk-based and phase-appropriate GxP project execution, including deviations, non-conformances, and CAPA implementation.
- Develop SOPs, deliver CQA training, and promote continuous improvement across client and internal teams.
- Contribute to commercial scoping, client satisfaction, project profitability, and promotion of CQA consulting services.
Requirements
- Bachelor’s degree in Pharmacy or another appropriate discipline.
- 10 or more years of Quality Assurance experience in GxP settings.
- 2–3 or more years of experience working as a Qualified Person.
- Thorough understanding of the US FDA, ICH, EMA, and MHRA regulatory landscape.
- Fluent English required; another EU language is advantageous.
- Project management, prioritisation, collaboration, and stakeholder management skills.
Culture & Benefits
- Remote working opportunity with hybrid collaboration encouraged near an office.
- Competitive remuneration package and work-life balance.
- Work across pharmaceutical and biological projects and therapeutic disciplines.
- Inclusive workplace focused on diversity, equity, inclusion, innovation, collaboration, and continuous development.
Hiring process
- Applications are personally reviewed by a member of the recruitment team.
- Applicants receive an outcome after the application review.
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