If you are looking for a rewarding career in a fast-paced, collaborative, and innovative environment, then Certara is the place for you. We are looking for a Software Quality, Lead to join our global quality team and oversee the quality assurance activities for our software products and services. You will be responsible for ensuring that our software products and services meet the highest standards of quality, reliability, and compliance, as well as supporting our continuous improvement initiatives. You will also collaborate with other teams across Certara to foster a culture of quality and customer satisfaction.

Certara is a growing company that provides a dynamic and exciting place to work. Our purpose is to assist in accelerating the development of meaningful medicines that make an impact on our society and the people that need them most. Innovation and creativity are highly valued, and everyone is given the opportunity for training and continuous development. Our portfolio spans the discovery, preclinical, clinical and post-marketing phases of drug development, working with 1,200 commercial companies, 250 academic institutions, and numerous regulatory agencies.

As part of Certara, you will have the opportunity to work on challenging projects that leverage your skills and expertise, as well as learn from some of the best minds in the industry. You will also enjoy a competitive compensation and benefits package, a flexible work schedule, and a supportive culture that values diversity, inclusion, and excellence.

Certara is a Nasdaq listed company that accelerates medicines to patients, partnering with life science innovators. Together with our partners, we advance modern drug development with modelling and simulation, regulatory science, and market access solutions. Our unique portfolio of best-of-breed software and services along with 1000+ strong team of scientists and subject matter experts enable informed decision-making, higher R&D productivity, and improved patient outcomes.

Responsibilities for the Software Quality, Lead position include:

• Identify and manage cross-functional process improvement projects across the Quality Assurance organization;
• Manage CAPA and deviation identification, tracking, follow up, and closure;
• Evaluate and approve proposed changes of GxP and non-GxP systems prior to implementation;
• Review and approve system requirements and related test scripts pre and post execution to ensure efficacy in collaboration with Quality Engineering and/or Service Quality Assurance;
• Assist the customer-facing teams through the customer onboarding process, and any customer quality questions and validation requests;
• Define, implement, and maintain quality assurance methodologies and processes that all stakeholders can rally behind, and that are in line with the Quality Assurance organization, in collaboration with managers;
• Perform multiple quality assurance tasks while working in an Agile-like environment;
• Ensure adherence to approved standards, processes, and procedures and make recommendations on the adoption of industry best-practices;
• Ensure all components of the applications and systems and/or services for the product are properly documented for each release or service provided;
• Host and organize customer audits following the guidelines and standards set forth by the Quality Assurance organization;
• Manage customer audit documentation, observation investigations, and responses;
• Plan and execute internal audits in accordance with the audit schedule;
• Plan and execute vendor audits in accordance with established vendor management guidelines;

• Additional duties as assigned.

Education and Experience:

• Bachelor's Degreewith preference forComputer 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 GxP international regulations,
• Working knowledge of ISO 9001, ISO 13485, ISO 27000 series
• 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,
• Two+ years' experience with ISO 9001, ISO 13485, ISO 27000 series implementation/management.

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.