Full Time Contract Title or Role: Validation Lead Compensation: up to $75 Hourly commensurate with experience Location: Remote Length of Contract: 18 months + Position Description: We are seeking a Validation Lead to oversee several workstreams which include an ERP migration effort, interfaces, and other manufacturing systems. This role is a hands-on role that demands a deep understanding of validation, SDLC documentation, compliance regulations, and risk-based approaches. The ideal candidate will possess strong leadership skills, a keen eye for detail, and the ability to drive quality and efficiency across diverse teams, review documents/test scripts, and motivate teams. Responsibilities: + Project Portfolio Management: Oversee a portfolio of validation projects, tracking progress, reviewing documentation, identifying risks, and implementing mitigation strategies. + Team Coordination: Facilitate team meetings, coordinate activities, capture meeting notes and action items. + SDLC Documentation Review: Review SDLC documentation, including user requirements/test script, to ensure completeness, accuracy, and testability. + Risk-Based Approach: Maintain risk-based approach across project planning and execution tasks, prioritizing critical activities and allocating resources effectively. + Regulatory Compliance: Ensure adherence to relevant regulatory standards (e.g., FDA, ISO, GAMP 5) and industry best practices. + Quality Assurance: Collaborate with the QA team to develop and execute test cases, analyze test results, and identify defects. + Communication: Effectively communicate with project teams, stakeholders, and regulatory authorities. + Problem-Solving: Identify and resolve complex technical and procedural issues. Qualifications + Advanced knowledge of SDLC methodologies (Agile, Waterfall, etc.) and quality assurance principles. + Strong understanding of regulatory requirements (e.g., FDA, ISO, GAMP 5) and Risk Based Approaches (CSV/CSA). + Proven experience in leading and managing validation teams. + Excellent written and verbal communication skills. + Strong organizational and time management skills. + Ability to work independently and as part of a team. + Experience with risk-based approaches and problem-solving techniques. If you are a highly motivated individual with a passion for quality and compliance, we encourage you to apply. Education & Certifications: + Bachelor's degree in a relevant field (e.g., Computer Science, Engineering, Information Technology). Equal Opportunity Statement: RCM is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. Pay Transparency: RCM believes in transparency and fairness in compensation. We are committed to providing our employees with competitive salaries that reflect their skills, experience, and contributions to our organization. As part of our commitment to pay transparency, we want to provide you with as much information as possible about our compensation practices. Disclaimer: This job posting is intended to describe the general nature and the level of the work to be performed. It is not intended to include every job duty and responsibility specific to the position. RCM reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. About RCM: RCM is a leading provider of Business, IT, and Engineering Services to over 1,000 clients in the commercial marketplace. RCM partners with clients to define, implement and manage a broad range of technologies across multiple platforms, systems, and networks. Our broad geographic presence ensures that a proven and reliable tactical and strategic capability is available and deployable virtually everywhere in North America.