Quality Assurance Manager

Biomapas is a functional and full outsourcing solution provider to the global life science industry. As a trusted partner for biopharmaceutical, medical device, cosmetics, and food supplement companies, we have one-stop-shop clinical research capabilities in high recruiting countries, delivering regulatory and pharmacovigilance excellence across Europe, CIS, MENA, and LATAM regions through the entire product lifecycle. Our in-house experience combined with a hands-on mindset allows for tailored solutions to complicated challenges that emerge on your path to commercialization. Our professionals execute your projects efficiently, cost-effectively and aspire to partner with you and become an integral part of your team from Early Development to Commercial success.

• Higher education in Life Sciences (e.g., Pharmacy, Medicine, Biology, Biotechnology, or related discipline)
• Knowledge of EU Good Pharmacovigilance Practices (GVP) is required; knowledge of Good Clinical Practice (GCP) is an advantage
• At least 5 years of experience in pharmacovigilance and/or clinical research environment, including quality assurance experience related to GVP and/or GCP activities
• Knowledge of other GxP requirements and ISO 9001, ISO27001, ISO13485 standards is an advantage
• Strong computer literacy and experience with eLMS and eQMS programs
• Ability to develop quality management systems and procedures
• Professional level English in oral and written communication
• Ability to apply critical thinking and problem-solving skills
• Excellent presentation, written, and oral communication skills

• Develop, review, and manage standard operating procedures (SOPs) ensuring conformance with local and international requirements and standards
• Assure effectiveness and continuous improvement of the quality management system ensuring clinical trials, pharmacovigilance, regulatory affairs, and good clinical practice training services conform to applicable regulations and standards such as ISO 9001, ISO13485, and ISO27001
• Conduct GxP audits in accordance with client agreements and internal audit programs
• Manage vendors’ quality assessments and audits
• Coordinate during second and third party audits or regulatory GCP and GVP inspections; manage corrective and preventive action plans following audits
• Complete and manage quality management system documentation and accountability forms
• Identify non-compliances, present audit findings, oversee implementation and control effectiveness of corrective and preventive actions, provide improvement recommendations
• Assist in performing root-cause analysis and problem-solving to identify effective corrective actions and process improvements
• Participate in staff training by preparing and presenting relevant quality and legal requirement trainings
• Implement and monitor processes that ensure quality
• Provide assistance for all quality management activities

Position is in Lithuania or any EU country.