Hybrid Senior Quality Assurance Officer – GDP

at myTomorrows

• Job title: Senior Quality Assurance Officer – GDP
• Job type: Full Time
• Experience level: Senior
• Salary: Not specified
• Degree requirement: Bachelor's Degree
• Location requirements: Hybrid, Amsterdam, Netherlands

About the role

• Quality Assurance Officer in a global health tech company ensuring compliance with GMP and GDP standards. Collaborating with cross-functional teams to maintain quality and information security management systems.

Responsibilities

• Prepare product and batch release documentation and support batch disposition
• Lead internal audits and support external vendor and regulatory audits
• Manage deviations, complaints, temperature excursions, CAPAs and Change Controls
• Maintain our electronic QMS and draft procedures, templates and training materials
• Deliver cGxP training and manage training records
• Prepare PQRs, annual updates and quality reports
• Support supplier qualification, customer approval, and vendor performance monitoring
• Contribute to qualification, validation and periodic reviews of GxP computerized systems

Requirements

• Bachelor's degree in a relevant field, ideally (bio)pharmaceutical
• At least 4 years of pharmaceutical QA experience
• Strong knowledge of EU GMP, GDP and related legislation
• Experience with QMS systems, internal audits and batch review
• Skilled in root cause analysis, CAPA and Quality Risk Management
• Excellent attention to detail and strong communication skills
• Professional English proficiency
• Nice to have: external audit experience, FMEA, experience in RA, PV, MA or Supply Chain, and system qualification experience.

Benefits

• Impactful work that helps patients gain access to potentially lifesaving treatments.
• International work environment, scale-up energy, and a flat organizational structure that encourages creativity and accountability.
• Competitive salary, annual performance bonus, and an Employee Stock Option Plan.
• Health insurance benefits through Cigna.
• 401K where we match 100% of employee contributions up to the first 3% of pay and 50% of employee contributions to the next 2% of pay.
• Great career development opportunities in a fast-growing company.
• Learning and development budget alongside internal knowledge-sharing sessions.
• Remote working model. We also have an office in Brooklyn in where you can work with colleagues.
• Policies to support working parents.
• Unlimited access to professional guidance by certified psychologists via OpenUp
• An annual ‘myTomorrowland’, which is a 2-day company-wide celebration!