Quality Assurance Manager

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Biomapas

WebsiteLinkedInAll Job Openings

201 - 500 employees

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

Biotechnology • Pharmaceuticals • Healthcare Insurance

Biomapas is a comprehensive outsourcing solution provider catering to the global life science sector. The company acts as a strategic partner for biopharmaceutical and medical device companies, offering extensive clinical research services worldwide. Biomapas covers the entire product lifecycle from regulatory compliance to pharmacovigilance and medical information. The company operates across various regions including Europe, CIS, EAEU, MENA, LATAM, and the US, ensuring high-quality, efficient, and cost-effective methodologies to deliver superior service and strategic advantages. With a focus on clinical trials, pharmacovigilance, and regulatory affairs, Biomapas is equipped to navigate complex regulatory environments and manage clinical trial data effectively, contributing to clients' commercial success.

📋 Description

• Develop, review, and manage standard operating procedures (SOP’s) of the company processes by assuring conformance with local and international requirements and standards • Assure the effectiveness and continuing improvement of the quality management system, that clinical trials, pharmacovigilance, regulatory affairs, and good clinical practice training services conform to applicable regulations, good clinical, pharmacovigilance (GVP), good Clinical practice (GCP) or other applicable practice guidelines, ISO 9001, ISP13485 and ISO27001 standards requirements • Conduct GxP audits according to the agreements with clients and/or internal audits programs • Manage vendors’ quality assessments and audits • Coordinate activities during second, third party audits or regulatory GCP and GVP inspections in the company and manages corrective and preventive actions plans after the audits • Complete and manage quality management system documentation and required accountability forms • Identify non-compliances, present, and discuss the audits findings, oversee implementation, and control effectiveness of corrective and preventive action plans, provide recommendations for improvement • Assist in performing root-cause analysis and other problem-solving activities to identify effective corrective actions and process improvement in collaboration with the personnel • Participate in the training process of the staff by preparing and presenting quality and legal requirements relevant trainings • Implement and monitor processes that ensure quality • Provide assistance for all quality management activities

🎯 Requirements

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

🏖️ Benefits

• Professional growth and career opportunities • International team and environment • Bonus based on annual performance • Personal accident and business trip insurance • Additional health insurance • Influenza vaccines • Rewarding referral policy • Team building, global meetings, B active events