Senior Technology Auditor, QA

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(R).

About the Role

We are seeking an Auditor (Quality Assurance Auditor) to join our team. As an Auditor, you will lead and execute comprehensive Good Practice (GxP) audits across all phases of clinical research, ensuring regulatory compliance and maintaining the highest quality standards. This position plays a key role in evaluating quality systems, identifying process improvements, and supporting clinical trial integrity. You'll collaborate with cross-functional teams, follow industry-standard audit procedures, and contribute to quality assurance initiatives from planning through reporting and follow-up. Responsibilities include conducting independent and co-audits, managing audit findings, coordinating internal audit programs, and providing consultancy on regulatory compliance and quality matters.

You'll join a fast-paced, growth-oriented environment focused on making a meaningful impact through rigorous quality oversight, regulatory compliance, and continuous process improvement. With diverse teams and continuous learning opportunities, the Auditor can explore career paths and expand skills across clinical research quality assurance.

Key Responsibilities

Lead, plan, schedule, and independently perform a range of GxP audits across all phases of clinical research, including project-related audits, system and process audits, supplier qualification and re-qualification audits, Trial Master File audits, and safety/pharmacovigilance audits to evaluate quality systems against regulatory requirements and applicable guidelines

Deliver high-quality audit reports within specified timelines and budgets, independently or with limited oversight; lead or participate in complex audits including for-cause audits, co-audits, and observed audits with client representatives and other QA auditors

Collect, review, and escalate responses to audit findings; ensure timely and satisfactory quality of responses and formal documentation; act as point of consultancy for Operations and Quality regarding implementation of corrective actions and escalation of quality events

Lead and coordinate internal audit programs at global and regional levels; develop audit tools including report templates, checklists, and standard communications; report audit outcomes and trends to process owners and QA Senior Management

Act as QA Lead on billable audit programs; arrange stakeholder meetings, ensure audits meet client requirements, escalate systematic issues, and maintain client relationships to ensure high satisfaction and identify opportunities for additional services

Support Serious Breach investigations and help oversee project teams to reach conclusions regarding reportability of critical quality events

Support training and mentoring of new and less experienced auditors through co-audits, training delivery, and knowledge sharing; assist in developing training materials, auditing tools, and guidance

Provide consultation and interpretation on regulatory compliance to internal and external clients regarding GxP and safety/pharmacovigilance requirements; support development and improvement of Parexel procedures, systems, and tools

Facilitate client audits and regulatory inspections; liaise with external industry and regulatory contacts to determine best practices for GxP implementation

Maintain sound knowledge of Parexel policies, procedures, and guidelines; proactively identify areas for process improvements and provide input to management

Build and maintain strong working relationships with internal and external customer groups; work effectively in team environments and collaborate on quality-related initiatives

Candidate Profile

You'll thrive in this role if you bring:

Exceptional analytical, problem-solving, and decision-making skills with the ability to consider the big picture and recommend appropriate corrective actions

Excellent interpersonal, verbal, and written communication skills, including the ability to present at conferences, meetings, and training sessions

Strong organizational and time management skills with the ability to prioritize workload and manage multiple and varied tasks and projects with enthusiasm

Experience working in clinical research, healthcare, or a regulated environment with demonstrated knowledge of Good Practices and regulatory requirements

The ability to work independently and consistently in a fast-paced environment while being detail-oriented and a critical thinker

A patient-focused mindset and strong attention to detail with the ability to diplomatically address sensitive issues confidentially and professionally

Ability to rapidly learn and apply Parexel and client procedures; comfort working with multiple computer systems and software, including Microsoft Office

Team leadership abilities, a positive attitude, and the ability to work effectively in a multicultural and matrix environment with multiple supervisors

Required Qualifications

Bachelor's degree in biological science, technology, pharmacy, or other health-related discipline, or equivalent qualification or clinical research experience

Minimum of 2 years of experience in quality assurance and auditing, including sound experience with applicable GxP auditing

At least 5 years of experience in regulatory affairs, clinical research, monitoring, data management, safety/pharmacovigilance, pharmacy, laboratory, or other relevant area in life sciences such as technology or third-party supplier management

Excellent knowledge, understanding, and experience of Good Practices (GxPs) and international, national, and local regulations and laws related to clinical trials and other clinical research

Strong communication, organization, and problem-solving skills

Preferred Qualifications

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

Experience with GMP and GLP auditing, GCLP accreditation audits, or supplier qualification audits

Familiarity with quality management systems, audit management tools, and regulatory inspection processes

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.

If this job doesn't sound like the next step in your career, but perhaps you know of someone who'd be perfect fit, send them the link to apply!

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