Compliance Program Manager (Quality)

Overview

As a Compliance Program Manager (Quality) in the Compliance Standards & Data Privacy organization within Certara, you are part of a global, fast-paced IT organization with the primary mission to provide capable & resilient world-class oversight and guidance to professional services, software, and corporate business units ensuring our team members have the ability to perform at the highest level in service of our customers.

The Compliance Standards & Data Privacy function relies on experience and judgment to plan and accomplish goals through implementation of GRC best practice methodologies, governance, and tooling. This Compliance Program Manager role will plan, lead, and maintain Certara's ISO 9001:2015 Quality Management System (QMS). This role is responsible for overseeing all activities related to ISO 9001 compliance, ensuring certification readiness, supporting internal and external compliance audits, promoting a culture of quality across the organization, and delivering continuous improvement initiatives across business functions.

The ideal candidate will have a strong background in ISO 9001, quality systems, auditing, and process optimization. Experience with information security standards (e.g., ISO/IEC 27001) or data privacy frameworks is highly desirable, especially in regulated or tech-driven environments. They will have a wide-breadth of compliance expertise, excellent project management skills, and the ability to collaborate across departments. In addition, the ideal candidate will have sufficient technical skills and experience in managing and maintaining the applicable quality systems.

This role requires understanding of consulting services & software organizations as well as internal corporate functions.

Responsibilities

• Lead the strategy, development, implementation, maintenance, and improvement of the ISO 9001 Quality Management System (QMS).
• Ensure compliance with ISO 9001 standards, company policies, and regulatory requirements.
• Plan and coordinate internal audits; oversee the scheduling and coordination of external compliance audits and certification processes.
• Act as the primary point of contact for ISO 9001-related inquiries and audits.
• Partner with cross-functional teams (Engineering, Consulting, Operations, Quality Assurance, IT, Security) to ensure process and QMS documentation alignment, and adherence to quality standards.
• Develop, update, and maintain QMS documentation including policies, procedures, work instructions, and quality manuals. Work with other Program Managers to maintain Integrated Management System (IMS) documentation.
• Manage non-conformances using root cause analysis and quality tools and drive corrective and preventive action (CAPA) processes.
• Identify, implement, and maintain automation or digital solutions to streamline QMS processes.
• Support the alignment and integration of ISO 9001 processes with ISO/IEC 27001 and other frameworks and standards.
• Contribute to risk assessments related to data integrity, confidentiality, and business continuity.
• Conduct training sessions to ensure staff awareness and understanding of ISO 9001 requirements.
• Foster a culture of continuous improvement, accountability, and quality excellence across departments.

Qualifications

• Bachelor's degree in Engineering, Quality, Business Management, or a related field.
• 7+ years of experience in compliance, risk management, or a related field.
• 7+ years of experience in quality management or ISO 9001 program administration.
• 7+ years of experience working in consulting services & software organizations, preferably in drug discovery and healthcare industries.
• 3+ years of experience working with ISO 27001 and data privacy compliance control frameworks.
• In-depth knowledge of ISO 9001:2015 standards and QMS implementation.
• Proven experience managing full life cycle of ISO 9001 certification, from gap analysis to audit and surveillance.
• Proven experience integrating ISO 9001 and ISO 27001 frameworks and administration of Integrated Management System (IMS).
• Proven experience managing internal audits, external compliance audits, and corrective action processes.
• Lead Auditor certification (ISO 9001) is highly preferred.
• Demonstrated Technical abilities to understand the complexity of IT/Security Operations.
• Demonstrated ability to lead or oversee cross-functional QMS projects involving multiple departments or global sites.
• Demonstrated knowledge of how ISO 9001 interacts with data governance or ITGCs (IT General Controls).
• Familiarity with ERP/CRM/SFA/PSA systems, and security and privacy governance tools.
• Skilled in process mapping, process analysis, and identifying process inefficiencies.
• Experience in using data-driven decision-making and statistical analysis to improve quality outcomes.
• Strong organizational, analytical, and problem-solving skills.
• Excellent communication and interpersonal skills; able to influence and collaborate across departments; meticulous attention to quality and detail to ensure completeness and accuracy.
• Capable of influencing stakeholders at all levels.
• Comfortable working in a fast-paced, evolving environment.

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.