Manager, Quality

Parexel•Glendale, CA

56d•$135,000 - $140,000•Hybrid

About The Position

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. About Parexel Parexel 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 Role We 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.

Requirements

8 or more years of experience in clinical research or equivalent
1-5 years of experience managing people
Expertise in ICH-GxPs and regulatory requirements
English proficiency in written and oral communication
Strong communication, organization, and problem-solving skills
Excellent communication skills, including verbal and written communication, active listening, and ability to facilitate group discussions
Strong interpersonal skills with ability to develop relationships, build rapport, persuade and influence teams, and develop talent
Expert project management capabilities with strong organizational and planning skills, combined with competency in risk management and thoughtful action planning
Personal awareness and emotional intelligence, with ability to self-motivate, innovate, delegate, and manage time while taking ownership of deliverables
Robust skills in interpreting, synthesizing, and extracting pertinent data to identify areas of risk, trends, and aggregated issues
Adaptability to changing environments, ability to think quickly, manage ambiguity, and learn new tasks
Quality-oriented mindset with strong attention to detail, initiative, and accountability for deliverables
Expertise in managing the complexity of a matrix environment while valuing teamwork and collaboration

Nice To Haves

Ability to travel up to 10% as needed

Responsibilities

Lead and manage Risk and Compliance Leads, establishing individual contributions to departmental goals and supporting achievement of collective objectives
Oversee EPRCM-specific risk management initiatives, identifying, categorizing, and scoring risks while developing and implementing effective mitigations across clinical trials and EPCUs
Ensure compliance with Parexel standard operating procedures, regulatory requirements, and applicable curricula, while verifying accurate time recording and performance management for direct reports
Lead 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 planning
Prepare for and support sponsor audits and regulatory inspections, partnering with Quality Assurance to oversee internal audits and serve as an escalation point for critical issues
Establish and sustain client relationships, serving as Account Risk and Compliance Lead (ARCL) when assigned, including client-level risk management, quality oversight, and quality agreement development
Attract, recruit, retain, and develop EPRCM staff through engagement, training, performance measurement, and constructive feedback focused on individual development
Identify opportunities to enhance the Quality Management System and Risk Management through feedback, process improvement initiatives, and participation in Quality Forum and Quality Review Board activities
Mentor EPRCM Leaders and Risk and Compliance Leads, facilitating induction, designing training, and providing feedback on progress