Freelance/Contract - Principal/Senior Quality Control Consultant

Job description

For the past 25 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs. ProPharma is currently looking to partner with a highly experienced Quality Control Consultant (Senior/Principal level) for a contract project based mainly onsite just north of Solna. This project will run at least to the end of 2026; it is full time (1.0FTE) and requires immediate availability for success. We are looking to partner with independent Consultants ideally based in Sweden or within the region (Scandinavia ideally but open to the UK/EU if you can travel). Essential Functions: Provide technical leadership across a variety of matters linked to our clients Quality Control group Act as the SME to help guide and lead new initiatives to ensure regulatory compliance Perform key reviews of the QC performance and provide skills to lab compliance, analytical testing and GMP Lab operations Oversee testing activities Actively review activities and identify areas for improvement linked to key global regulations (FDA ideally) Lead complex investigations into key data linked to QC activities Lead key Quality led activities like CAPA’s, reviewing audit findings, inspection readiness etc. Overall support of our clients Quality Control activities and ensure all operations are regulatory compliant to all necessary regulations Necessary Skills and Abilities: Must be educated to at least a BSc level or higher with a life-sciences discipline or related discipline to the role Proven and extensive experience working within the Pharmaceutical or Biotechnology sector is a must Can thoroughly demonstrate advanced experience in Quality Control within the life-sciences sector Thorough experience to FDA regulations would be highly advantageous Fluent in English (Swedish would also be desirable) Can work mainly office based north of Solna throughout the project Must have extensive skills in problem solving, support corrective procedures and understanding key regulations to ensure compliance We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed. All applications to roles at ProPharma are personally reviewed by a member of our recruitment team. We do not rely on AI screening tools to support our hiring process. You will always receive an outcome to your application so that you have an answer from us - whether you're successful or not. Whilst ProPharma supports remote working, we also recognise the value that comes from in person collaboration. As such, we encourage any new hires that are based within a reasonably short commute of one of our offices to work on a hybrid basis and spend some time working from that office location, as agreed with your manager. All applications will be treated on their own merit and candidates will not be at any advantage or disadvantage based on their proximity to an office. ***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***