JOB OBJECTIVE: Leads and manages a team that maintains Promega’s current eQMS software while serving as a pivotal project team member in transitioning to a modern eQMS platform. Ensures compliance with regulatory requirements, fosters team development, and delivers innovative quality system solutions aligned with business goals CORE DUTIES: Leadership and Strategy 1. Act as a key contributor in transitioning to a next generation eQMS platform, aligning with business objectives and compliance standards. 2. Ensure the existing eQMS meets internal and external requirements, including compliance with 21 CFR and ISO standards, while facilitating a seamless transition to the new system. 3. Translate organizational strategy into actionable plans for both maintaining current systems and implementing new software solutions. 4. In cooperation with QA leadership, will serve as system owner of existing and new eQMS solution. 5. Identify and lead process improvement initiatives within the department as well as across the organization. Team Management 1. Direct and oversee eQMS team members by assigning, prioritizing, and monitoring their work to align with business needs. 2. Provide daily support to eQMS users and allocate resources effectively to maintain operational continuity. 3. Offer coaching, performance feedback, and career development opportunities to foster a high-performing team. Compliance and Quality Oversight 1. Assure design and performance requirements are met for new and revised eQMS modules through direct oversight or active participation in development and testing. Ensure data is secure, maintained, and meets both business and compliance requirements. 2. Develop methods for prioritizing eQMS work to address user and business needs promptly. 3. Ensure that documentation is accurate, comprehensive, and meets procedural requirements. Cross-Functional Collaboration 1. Represent QA in cross-departmental interactions and external discussions with suppliers and service providers. 2. Collaborate with other departments to establish staffing, budgeting, training, and capital expense plans. 3. Lead or contribute to projects that enhance company operations and compliance infrastructure. Other Responsibilities 1. Represent Promega during external inspections and audits, ensuring readiness and compliance. 2. Uphold ethical, legal, and regulatory requirements in all business activities. 3. Demonstrates inclusion through their own words and actions and is accountable for a safe workspace. Acts with kindness, curiosity and respect for others. 4. Understands and complies with ethical, legal and regulatory requirements applicable to our business. KEY QUALIFICATIONS: 1. B.S. or M.S. in Computer Science/Engineering or a related field. 2. 7+ years’ experience in software development or software quality assurance. 3. Proven success in cross-functional environments, with advanced written and verbal communication skills. 4. Independent self-starter with strong analytical, leadership, and project management capabilities. PREFERRED QUALIFICATIONS: 1. Experience in a cGMP environment with a solid understanding of ISO 13485 and QSR Quality System requirements. 2. Project Management Professional (PMP) certification or equivalent. PHYSICAL DEMANDS: 1. Ability to work with computers for extended periods. At Promega, we value diversity and strive to create an inclusive workplace. We are proud to be an Equal Opportunity Employer, making employment decisions without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, disability, or any other protected class.