Compliance and Quality Assurance Consultant (GxP)

Location: Sweden; remote working is supported, with hybrid work encouraged for new hires within a short commute of an office.

Company

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

What you will do

• Manage and support quality assurance, regulatory, and GxP consulting projects for clients.
• Develop Quality Management Systems, provide QA oversight, conduct GxP audits, and address GMP issues.
• Support client MIA/WDA projects, including QP batch certification and QP/RP/RPi responsibilities where applicable.
• Consult on deviations and non-conformances, implement CAPA, write SOPs, and deliver quality and compliance training.
• Contribute to risk-based GxP project execution, client satisfaction, business development, and CQA marketing content.
• Maintain billable project work and travel as required.

Requirements

• Bachelor’s degree or equivalent in a scientific discipline; an MSc or PhD is preferred.
• 5–8 years of relevant experience in quality assurance and regulatory/GxP compliance.
• Strong knowledge of GxP principles, CFRs, EU GMP/GDP, and applicable FDA, ICH, EMA, and MHRA regulations.
• Fluent English and Swedish, or another EU language, required.
• Experience with GxP systems, quality management, GMP auditing, analytical work, and CAPA implementation.
• QP/RP eligibility or previous QP registration is preferred where applicable; auditing-focused roles require at least five audits in the past year.

Nice to have

• Graduate degree in a scientific discipline.
• Previous registration as a Qualified Person.
• Recent GMP auditing experience and eligibility to act as QP or RP.

Culture & Benefits

• Remote working is supported, with hybrid collaboration encouraged near an office.
• Inclusive workplace focused on diversity, equity, inclusion, and psychological safety.
• Opportunities to work with biotech, medical device, and pharmaceutical clients across the product lifecycle.
• Employees are encouraged to contribute innovative, collaborative, and entrepreneurial ideas.

Hiring process

• Applications are personally reviewed by a member of the recruitment team.
• Applications are not screened using AI tools.
• Applicants receive an outcome after the application review.