Manager, Quality

Parexel International; Glendale (CA); Hybrid; USD 120,000 - 140,000; Full time

Benefits offered by this job

Health, Vision & Dental Insurance

Tuition Reimbursement

Vacation/Holiday/Sick Time

401(k) with Company match

Life Insurance

Pet Insurance

Work/Life Balance

Job summary

Parexel International in California (Hybrid) is seeking a Manager, Early Phase Risk & Compliance to lead Risk and Compliance Leads supporting EPCUs, driving quality and regulatory adherence across early phase trials.

You will oversee risk management processes, audits, client relations, and staff development, ensuring timely inspections readiness and alignment with Parexel SOPs and ICH-GxP requirements.

Qualifications

• 8+ years in clinical research or equivalent.
• 1-5 years managing people.
• Expertise in ICH-GxPs and regulatory requirements.
• English proficiency in written and oral communication.
• Strong organization and problem-solving skills.

Responsibilities

• Lead and manage Risk and Compliance Leads across EPCUs.
• Oversee risk management initiatives and mitigations.
• Ensure compliance with Parexel SOPs and regulatory requirements.
• Lead facility inspection readiness checks and risk reviews.
• Prepare for sponsor audits and regulatory inspections.
• Develop client relationships and act as ARCL when assigned.
• Mentor staff and drive training and development.
• Identify opportunities to improve QMS and risk management.

Skills

Excellent communication

Interpersonal skills

Project management

Risk management

Time management

Data interpretation

Travel readiness

Education

Bachelor's in life science

Master's in science/tech

Job description

Manager, Early Phase Risk & Compliance (On-site 2 - 3 days)

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.

Key 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

Candidate Profile

You'll thrive in this role if you bring:

• 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
• Ability to travel up to 10% as needed

Required Qualifications

• 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

Education

Bachelor's Degree in life science or health-related discipline

Master's Degree in a science, technology, or industry-related discipline

Benefits and Compensation

Health, Vision & Dental Insurance

Tuition Reimbursement

Vacation/Holiday/Sick Time

Flexible Spending & Health Savings Accounts

Work/Life Balance

401(k) with Company match

Pet Insurance

For a complete list of benefits, please visit www.parexel.com/us-benefits.

The potential base pay range for this role is $120K - $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.

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 Disclaimer

Parexel 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.