✨ WHY CHOOSE MEDSIR ✨

We are a Barcelona-based fastest-growing company founded by scientific experts 🔬. We are dedicated to the design and management of innovative strategic clinical trials in oncology, from study conception to the publication of study results 💊📃. Together, we create the best strategies that are both clinically relevant and scientifically meaningful 💉. We strive to improve our knowledge of this complex disease and the vast array of available treatments in a fast-innovative way 🚀.

At MEDSIR, you will have the job of your life while working together towards our shared 🌟 mission 🌟 bringing novel treatments to cancer patients worldwide. We welcome top performers that will bring new ideas, diverse perspectives, and provide you the opportunities and freedom to grow and make a real impact ❤ in patients' lives and science... all while having great fun 🎉.

🤓 ABOUT THE OPPORTUNITY

The Quality Assurance Director defines, leads, and oversees the company's Quality strategy, ensuring full compliance with national and international regulations, standards, and guidelines, while driving a culture of continuous improvement.

The Quality Assurance Director provides strategic guidance, leads the Quality Assurance team, and acts as the primary representative of MEDSIR in front of regulatory authorities, clients, and external partners regarding quality matters.

The position reports to the Chief Data Director.

🚀 HOW YOU WILL CONTRIBUTE:

• · Strategic Leadership: Define the company's global Quality strategy, policies, and objectives, ensuring alignment with corporate goals and regulatory expectations.

  · Team Management: Lead, mentor, and develop the Quality Assurance team, fostering professional growth and high performance.

  · Governance & Oversight: Provide guidance and oversight to ensure compliance with GCP, ICH, ISO, and other applicable international standards.

  · Quality Systems Management: Ensure the establishment, maintenance, and continuous improvement of Quality Management Systems (QMS), including SOPs, manuals, guidelines, and work instructions.

  · Regulatory Compliance & Inspections: Act as company lead during regulatory authority inspections and client audits, ensuring readiness and effective communication.

  · Audit & Risk Management: Oversee risk assessments, internal/external audits, and vendor qualification. Ensure timely implementation of corrective and preventive actions (CAPAs) and follow-up of quality events (issues, deviations, non-compliance).

  · Training & Culture of Quality: Define training programs to strengthen quality awareness across the organization. Promote a culture of quality and compliance at all levels of the company.

  · Management Reporting: Provide regular reports and recommendations to the Directive Committee and Line Managers on quality metrics, risks, and improvement opportunities.

  · Continuous Improvement: Identify trends and opportunities to optimize processes, systems, and tools, ensuring efficiency while maintaining compliance and quality excellence.

  · External Representation: Act as the main point of contact for clients, vendors, and regulatory authorities in all quality-related matters.

💪 WHAT DO WE VALUE FOR THIS OPPORTUNITY?

• · Bachelor's degree in Life Sciences, Pharmacy, or related field.

  · Master's degree or advanced certification (e.g., Quality Management, Regulatory Affairs) preferred.

  · Experience in Quality Assurance/Quality Management within the pharmaceutical, biotech, or clinical research industry.

  · Experience with project and quality management tools.

  · Knowledge of ISO 9100:2015 is a plus.

  · Demonstrated ability to represent the company during regulatory inspections and client audits.

  · Strategic mindset combined with strong problem-solving and decision-making skills.

  · Excellent leadership, communication, and interpersonal skills to engage with stakeholders at all levels.

  · Strong organizational and time management abilities, with capacity to manage multiple priorities in a dynamic environment.

  · Proficiency in Microsoft Office applications and QMS/clinical trial management systems.

• Fluent English and Spanish.

📢 THE THINGS YOU REALLY WANNA KNOW 😉:

At MEDSIR, we believe that employees today want to evolve in collaborative, high-growth environments where they can demonstrate their abilities and thrive both professionally and personally. We are convinced that employees need to find alignment between their inner values and their company's culture and mission to unlock their full potential. We work to create a culture of empowerment, continuous learning and growth where everyone can bring expertise, own projects and easily measure their impact.

🙌 BENEFITS

🤓 Work with world-renowned clinicians and KOL's on high-level publications and papers.

🚀 Fast growth, we are an early-stage company with a multidisciplinary team and many growth opportunities.

🏡 Work-life balance - hybrid working model and flexible hours focusing on performance rather than office hours.

🎓 Unlimited access to GoodHabitz courses and regular workshops (external & internal) to continue your development.

📚 Opportunities to participate in scientific conferences & events at national and international level.

💉 Private health Insurance (AXA).

🏝 Work-from-abroad policy depending on position and local legislation.

🌏 A young & international team with a company culture focused on development.

☕ Positive, dynamic, and passionate work environment.

💪🏽 Elevate your wellness with Wellhub (formerly GymPass)! One subscription for the best in fitness, mindfulness, therapy, nutrition, and sleep support-all in one place.

💸 "Flexible compensation plan" to help you save taxes and increase your net salary (Cobee).

🎂 A free day on your birthday so you can truly celebrate!

🎉 Unforgettable MEDSIR events and regular get togethers.

👥 Equal employment opportunity, at MEDSIR we proudly pursue a diverse workforce and celebrate our differences.

🌇 A fantastic workplace located in 22@, Barcelona's new hub of innovation.

💻 We work with MacBook computer (Apple).

If you believe you match our values, you are unique and feel ready to make a change, we look forward to meeting you!

🧡 We are committed to fostering a diverse and inclusive workplace, where all individuals are treated with respect and equality, regardless of race, gender, age, religion, disability, or any other characteristic. We believe in providing equal opportunities for all and do not tolerate discrimination in any form.