Senior Quality Control Specialist

Novartis seeks a Senior Quality Control Specialist in Basel to lead bioanalytics reviews, ensure GxP compliance, and support laboratory operations through expert oversight of analytical data and processes.

This position is located in Basel, Switzerland, within the bioanalytics function. The specialist provides deep technical expertise to the laboratory team, ensuring that all activities and investigations adhere to GxP and HSE standards. A core part of the role involves the rigorous review and approval of analytical data to maintain operational efficiency and regulatory compliance.

Responsibilities

• Organize and oversee sampling workflows, ensuring proper documentation and alignment with both project-specific and routine laboratory schedules.
• Evaluate and authorize analytical test results for release, stability monitoring, and project milestones according to established procedures.
• Draft, assess, and approve analytical protocols, reports, trend analyses, KPIs/KQIs, and documentation required for regulatory submissions.
• Drive analytical project initiatives, including method implementation, technology transfers, new product introductions, and routine lab readiness.
• Act as the primary contact or subject matter expert for assigned products, pipeline projects, external collaborations, audits, inspections, and technical reviews.
• Oversee the management of deviations, out-of-specification (OOx) investigations, corrective and preventive actions (CAPA), and continuous improvement efforts to strengthen laboratory performance.
• Participate in supplier qualification, vendor management, contract negotiations, service level agreements, quality agreements, budgeting, and cross-functional governance.
• Guarantee strict adherence to cGxP, data integrity, quality, and HSE standards, covering equipment maintenance, calibration, training, risk assessment, and safe work practices.

Requirements

• A technical education with 3–5 years of experience, or a university degree in Pharmacy, Chemistry, or a related scientific field with 0–4 years of relevant experience.
• Prior experience in the pharmaceutical sector, active substance manufacturing, or GMP-regulated analytical laboratories.
• Solid understanding of Quality Control testing, sampling techniques, laboratory instrumentation, GxP regulations, data integrity principles, and quality decision-making frameworks.
• Hands-on experience supporting analytical release, stability studies, method transfers, deviation handling, CAPAs, trend analysis, and project documentation.
• Proven ability to collaborate effectively across internal functions, departments, external partners, and project teams.
• Strong communication skills, including proficient written and spoken English and fluency in the local language.
• Competency in MS Office and standard IT systems used for quality, laboratory, and documentation tasks.
• Demonstrated skills in collaboration, result orientation, analytical problem-solving, resilience, operational excellence, continuous learning, and digital awareness.

What the company offers

• An 18-month fixed-term contract.
• Comprehensive insurance coverage.
• Retirement and pension plans.
• Access to wellbeing resources.
• Global recognition programs.
• Flexible and hybrid working options where feasible.
• At least 14 weeks of paid parental leave.
• A performance-based bonus tied to specific performance metrics.

About the company

Novartis is dedicated to reimagining medicine and fostering an inclusive work environment with diverse teams that reflect the patients and communities they serve. The company upholds pay equity as a core principle, ensuring a respectful and dignified workplace for all employees.

• Commitment to reimagining medicine.
• Focus on building an inclusive and diverse workforce.
• Adherence to pay equity and respectful treatment of all staff.