Quality Assurance Manager

Overview

About Certara

Certara accelerates the potential of bringing medicines to market and to patients using biosimulation software, technology, and services to transform traditional drug discovery and development. Our clients include more than 2,400 biopharmaceutical companies, academic institutions, and regulatory agencies across 70 countries.

Our goal is to enable the life sciences industry’s use of data, modeling, and analytics to make better decisions across the various phases of discovery and drug development. Our software and scientists incorporate modern advances in scientific understanding, drug development experience, data analysis, and AI resulting in significant opportunities to decrease the cost and increase the probability of success for new drug approval and commercialization.

As a Quality Assurance Lead in the Quality, Compliance, and Trust (QCT) organization within Certara, you are part of a global, fast-paced team with the primary mission to provide resilient, world-class oversight and guidance over Quality for our software products and services.The QCT function relies on the experience and judgment of our team to plan and accomplish our quality assurance activities. The Quality Assurance Lead will ensure consistent implementation of quality practices and procedures primarily across our software products. In this role, you will be responsible for ensuring that our commercial offerings meet the highest standards of quality, reliability, and compliance, and for supporting our continuous improvement initiatives. You will coordinate the activities required to meet quality standards that satisfy both external and internal requirements, and collaborate with teams across Certara to foster a culture of quality and customer satisfaction.

Responsibilities

• Identify and manage cross-functional process improvement projects across the Software Business Units, including initiatives that increase the efficiency of Quality Assurance activities and operations.
• Review compliance and adherence to approved software development standards, processes, and procedures, and recommend the adoption of industry best practices.
• Represent and lead QA support for hosted on-site and remote customer audits, including executing timely responses to findings when applicable.
• Manage the intake, triage, and investigation of customer complaints, field issues, and quality issues through to closure, routing corrective and preventive actions to the CAPA process as applicable.
• Define, implement, and maintain quality assurance methodologies and processes, and align them with key stakeholders.
• Review and approve change-control process for GxP and non-GxP systems, assessing the impact of proposed software changes prior to implementation.
• Provide QA oversight for product releases by reviewing release documentation, assessing quality and compliance readiness, and partnering with Quality Engineering and Service Quality Assurance to support effective release decisions.
• Ensure all components of the applications, systems, and services for each product release or service are properly documented, and ensure validation documentation meets regulatory expectations.
• Manage the audit program, including maintaining a risk-based audit universe and the annual audit schedule under which internal, vendor, and customer audits are executed.
• Plan and execute internal audits in accordance with the audit schedule.
• Plan and execute vendor audits in accordance with established vendor management guidelines.
• Perform additional duties as required.

Qualifications

Education and Experience

• Bachelor's Degree with preference for Computer Science, Information Technology, the Natural Sciences, or Health Sciences.
• Six+ years’ experience in quality assurance.
• Two+ years’ Quality Audit experience.
• Two+ years’ experience in Computer Systems Validation.
• Extensive prior experience with international GxP regulations.
• Working knowledge of ISO 9001 and ISO/IEC 27001.
• Excellent communication skills.
• Attention to detail.
• Analytical mind and problem-solving aptitude.
• Strong organizational skills.

Bonus

• Prior experience with a software or information technology company.
• Quality Assurance Certification, such as Certified Quality Process Analyst (CQPA), Registered Quality Assurance Professional (RQAP).
• Prior experience within Clinical Trials or Life Science industry.
• Prior experience with software support services and ticketing systems.
• Prior collaboration experience with Software Engineering and/or Development.
• Working expertise of Atlassian suite, e.g., JIRA and Confluence.

What we offer

• Hybrid-way of working (8 days/month home office)
• Private health insurance (Medicare)
• Daily entry into Life1 Fitness Clubs
• We work with global Top500 companies (R&D) and leading academic institutions, giving you a chance to gain insights into these dynamically evolving industries.
• Inspiring working environment - leisure and recreation area, playing corner for children
• You will be a valued member of a creative and supportive agile team
• Everyday use of English in a multicultural environment

Location: Budapest, Váci Greens Office Park

Certara bases all employment-related decision on merit, taking into consideration qualifications, skills, achievement, and performance. We treat all applicants and employees without regard to personal characteristics such as race, color, ethnicity, religion, sex, sexual orientation, age, nationality, marital status, pregnancy, physical or mental condition, genetic information, military service, or other characteristic protected by law.