Manager, Quality

When our values align, there's no limit to what we can achieve.At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.Manager, Early Phase Risk & Compliance (Hybrid Role)About ParexelParexel is a leading global clinical development partner delivering insights-driven clinical and consulting solutions to the life sciences industry. With 22,000+ employees worldwide, we partner with biopharmaceutical companies and research sites to design and deliver patient-focused clinical trials that broaden access and make research a care option for anyone, anywhere.We work with focus, agility, and shared purpose -- moving with urgency to address patient needs and accelerate the delivery of new therapies. We embrace bold thinking, adapt quickly to change, and continually raise the bar for the speed and quality of clinical research. We are expanding our team and seeking talented individuals to help drive industry-leading innovation, With Heart.About the RoleWe are seeking a Manager, Early Phase Risk and Compliance to join our team in a hybrid capacity. As a Manager, Early Phase Risk and Compliance, you will lead and manage Risk and Compliance Leads who support Early Phase Clinical Units, driving strategic initiatives that enhance quality and ensure compliance with regulatory requirements, client expectations, and internal policies. This position plays a key role in risk management oversight, quality support for clinical trials, and regulatory compliance across Early Phase Clinical Units (EPCUs). You'll collaborate with cross-functional teams, follow industry-standard processes, and contribute to study operations from planning through closeout.Responsibilities include leading risk management initiatives, overseeing compliance with Parexel standards and regulatory requirements, managing and developing direct reports, and serving as a strategic partner to senior leadership. With diverse teams and continuous learning opportunities, the Manager, Early Phase Risk and Compliance can explore career paths and expand skills across clinical research and quality management.Key ResponsibilitiesLead and manage Risk and Compliance Leads, establishing individual contributions to departmental goals and supporting achievement of collective objectivesOversee EPRCM-specific risk management initiatives, identifying, categorizing, and scoring risks while developing and implementing effective mitigations across clinical trials and EPCUsEnsure compliance with Parexel standard operating procedures, regulatory requirements, and applicable curricula, while verifying accurate time recording and performance management for direct reportsLead facility inspection readiness checks and coordinate regular risk reviews to identify, categorize, and score potential risks and quality issues, confirming mitigations are integrated into departmental planningPrepare for and support sponsor audits and regulatory inspections, partnering with Quality Assurance to oversee internal audits and serve as an escalation point for critical issuesEstablish and sustain client relationships, serving as Account Risk and Compliance Lead (ARCL) when assigned, including client-level risk management, quality oversight, and quality agreement developmentAttract, recruit, retain, and develop EPRCM staff through engagement, training, performance measurement, and constructive feedback focused on individual developmentIdentify opportunities to enhance the Quality Management System and Risk Management through feedback, process improvement initiatives, and participation in Quality Forum and Quality Review Board activitiesMentor EPRCM Leaders and Risk and Compliance Leads, facilitating induction, designing training, and providing feedback on progressCandidate ProfileYou'll thrive in this role if you bring:Excellent communication skills, including verbal and written communication, active listening, and ability to facilitate group discussionsStrong interpersonal skills with ability to develop relationships, build rapport, persuade and influence teams, and develop talentExpert project management capabilities with strong organizational and planning skills, combined with competency in risk management and thoughtful action planningPersonal awareness and emotional intelligence, with ability to self-motivate, innovate, delegate, and manage time while taking ownership of deliverablesRobust skills in interpreting, synthesizing, and extracting pertinent data to identify areas of risk, trends, and aggregated issuesAdaptability to changing environments, ability to think quickly, manage ambiguity, and learn new tasksQuality-oriented mindset with strong attention to detail, initiative, and accountability for deliverablesExpertise in managing the complexity of a matrix environment while valuing teamwork and collaborationAbility to travel up to 10% as neededRequired Qualifications8 or more years of experience in clinical research or equivalent1-5 years of experience managing peopleExpertise in ICH-GxPs and regulatory requirementsEnglish proficiency in written and oral communicationStrong communication, organization, and problem-solving skillsEducationBachelor's Degree in life science or health-related disciplineMaster's Degree in a science, technology, or industry-related disciplineBenefits and CompensationHealth, Vision & Dental InsuranceTuition ReimbursementVacation/Holiday/Sick TimeFlexible Spending & Health Savings AccountsWork/Life Balance401(k) with Company matchPet InsuranceFor a complete list of benefits, please visit potential base pay range for this role is $135K - $140K. The actual salary offered may vary within this range based on several factors, including the position and level offered, skills, education, training, experience, professional achievements, and location.Some roles may also be eligible for additional incentives, bonuses, or other compensation programs. Our Talent Acquisition team will provide details on applicable bonus plans or incentive structures for eligible positions.We offer a comprehensive benefits package to eligible employees, which includes paid time off, a 401(k) match, life insurance, health insurance, and additional benefit offerings in accordance with the terms of our applicable plans.If this job doesn't sound like the next step in your career, but perhaps you know of someone who'd be a perfect fit, send them the link to apply!We believe in flexibility, growth, and creating space for people to do their best work. Join us and be part of a team where your contributions help shape the future of clinical research.EEO DisclaimerParexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.SummaryLocation: United States - Glendale - CaliforniaType: Full time PAREXEL