Compliance and Quality Assurance Consultant (Permanent)

About the role

ProPharma, a consultancy serving biotech, medical device and pharmaceutical organisations since 25 years, is looking for a Compliance and Quality Assurance (CQA) Consultant. The role supports the management of compliance and quality assurance projects and provides consulting and contract services to clients on quality and GMP issues, with a share of billable project work set quarterly.

Key responsibilities

• Represent the company in assigned areas of quality assurance and regulatory / GxP.
• Manage client projects such as QP batch certification, GxP auditing, Quality Management System (QMS) development and regulatory agency response, and act as Qualified/Responsible Person where applicable.
• Support risk-based, phase-appropriate GxP projects and help implement CAPA for deviations and non-conformances.
• Take part in the sales process, promote CQA services through social media content and blogs, and train clients and colleagues.
• EU or UK consultants can act as QP / RP / RPi for clients; eligible QPs may also hold the ProPharma MIA license QP role.

Required profile

• Bachelor's degree in a scientific discipline (MSc / PhD preferred).
• 5-8 years of relevant experience in quality assurance and regulatory / GxP compliance; previous QP registration preferred.
• At least 5 audits in the last year if the role is primarily auditing.
• Eligible to register as a Qualified Person and Responsible Person.
• Fluent in English and Swedish (or another EU language); willingness and ability to travel.

Required skills

• Strong working knowledge of GxP, CFRs and EU GMP / GDP.
• Knowledge of US FDA, ICH, EMA and MHRA regulations and guidance.
• GMP auditing experience preferred.
• Ability to plan, organise, control and execute projects while managing several tasks.