Senior Compliance & Quality Assurance (Qualified Person) Consultant (Pharmaceutical Quality)

Location: Sweden; remote working is available, while employees within a reasonably short commute of an office are encouraged to work on a hybrid basis.

Company

hirify.global provides regulatory, clinical, quality, compliance, pharmacovigilance, medical information, and R&D technology consulting services to biotech, medical device, and pharmaceutical organizations.

What you will do

• Serve as a subject matter expert in quality assurance, regulatory compliance, and GxP.
• Lead client projects involving MIA/WDA activities, QP batch certification, GxP auditing, and quality management systems.
• Provide independent consultation, project leadership, and risk-based GxP support across pharmaceutical and biological programs.
• Act as a Qualified or Responsible Person for clients where applicable.
• Support deviations and non-conformances through CAPA implementation, SOP development, training, and continuous improvement.
• Contribute to commercial scoping, client satisfaction, service promotion, and delivery profitability.

Requirements

• At least 10 years of quality assurance experience in GxP environments.
• At least 2–3 years of experience working as a Qualified Person.
• BSc-level education in Pharmacy or another appropriate discipline.
• Strong understanding of the US FDA, ICH, EMA, and MHRA regulatory landscape.
• Fluent English required.
• Demonstrated project management, prioritization, collaboration, and stakeholder management skills.

Nice to have

• Experience with development and marketed products.
• Knowledge of another EU language.

Culture & Benefits

• Permanent full-time opportunity.
• Remote working option with hybrid collaboration encouraged for employees near an office.
• Competitive remuneration package.
• Positive work-life balance.
• Inclusive workplace focused on diversity, equity, and inclusion.

Hiring process

• Applications are personally reviewed by a member of the recruitment team.
• Applicants receive an outcome regarding their application.