Manager, Operations

About WCG WCG delivers transformational solutions that accelerate clinical research and advance human health. We serve the experts, innovators, and pathfinders on the frontlines of science and medicine—empowering them to develop breakthrough therapies while ensuring the risks of progress never outweigh the value of human life. Together, we stimulate growth, maximize efficiency, and shape the future of clinical trials. Why WCG At WCG, we invest in our people because you are the driving force behind our mission. When you grow, our impact grows. When you thrive, research accelerates. We empower you to build a meaningful career while advancing the work that improves lives. What we offer: Comprehensive health and financial protection – Medical, dental, vision, life and disability insurance, 401(k) with company match, and flexible spending accountsResources that support your whole life – Employee assistance programs and work/life balance toolsInvestment in your growth – Referral bonuses, tuition reimbursement, on-the-job training, certification assistance, and continuing education supportTime to recharge – Paid holidays, vacation, and sick timePathways forward – Career development opportunities across One WCG We practice transparency in everything we do, including compensation. The salary range for this position reflects our commitment to fair, competitive pay based on your qualifications, experience, skills, education, and location. Together, we'll find the right fit for your expertise and our shared mission. Job Summary JOB SUMMARY: The Manager, Operations QA & Compliance, is responsible for managing quality assurance resources and establishing team goals and objectives in alignment with corporate quality goals.  The position also establishes and maintains quality assurance standards and measures across WCG services organizations and ensures such standards comply with regulatory requirements and industry standards.  This position is responsible for working alongside WCG leadership to achieve corporate and departmental compliance goals as well as ensuring the organization remains compliant with the Quality Management System, business processes, and emerging technology governance expectations. ESSENTIAL DUTIES/RESPONSIBILITIES: To perform this job successfully, an individual must be able to perform each essential duty and responsibility satisfactorily.  The requirements listed below are representative of the knowledge, skills, and/or abilities required.  Provides management responsibility for the implementation, maintenance, and continual improvement of WCG’s Quality Management System (QMS) in alignment with the Quality Policy, Quality Manual, applicable ISO standards, regulatory requirements, and WCG business objectives, using a process‑based and risk‑based approach to quality management. Defines, implements, and monitors quality objectives, key performance indicators, and quality trends; evaluates the effectiveness of QMS processes; and prepares quality performance data, risk assessments, and management review inputs to support leadership oversight and evidence-based decision making. Ensures effective control of QMS documented information, including policies, procedures, work instructions, and quality records, in accordance with defined documentation and record‑control requirements to support consistent execution of regulated and quality‑critical processes. Leads and oversees Quality Event and CAPA management activities, including deviations, corrective and preventive actions, and Notes to File (NTF), ensuring events are investigated using documented root cause analysis methodologies, corrective actions are risk‑based and proportionate, and effectiveness checks are performed and documented to verify sustained improvement. Plans, manages, and executes the internal audit and periodic review program in accordance with QMS and ISO requirements, including audit planning, execution, reporting, and follow‑up, to assess conformity, effectiveness, and ongoing suitability of QMS processes and controls. Identifies nonconformities, compliance gaps, and systemic risks; supports the development and implementation of corrective actions; and monitors remediation activities to closure to ensure ongoing conformity and improvement. Serves as a primary Operations Quality contact for client audits and third‑party assessments, including inspection readiness activities, audit coordination, response development, and follow‑up to ensure timely, effective, and sustainable resolution of audit and inspection findings. Provides quality assurance oversight of external vendor qualification and monitoring activities using a risk-based approach, ensuring vendors meet applicable quality, regulatory, and contractual requirements and that vendor performance and risks are periodically evaluated and escalated as appropriate. Leads quality oversight activities associated with the integration of newly acquired WCG businesses, ensuring planned and controlled onboarding into the WCG QMS, harmonization of policies and procedures, and alignment with established quality objectives, regulatory requirements, and ISO standards. Oversees and reinforces the responsible and compliant use of technology and AI enabled tools within Operations and Quality processes by ensuring governance controls, documented procedures, training, and monitoring mechanisms are established, implemented, and maintained in accordance with WCG policies, approved governance frameworks, and applicable regulatory and information security requirements. Collaborates cross‑functionally with Compliance, Information Security, Legal, Technology, and business stakeholders to identify, assess, and manage quality and compliance risks associated with systems and emerging technologies, consistent with WCG’s Quality Risk Management framework. Supports personnel competence and quality awareness by ensuring appropriate training, coaching, and