QC Manager (FSP)

May 2, 2026

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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.Job Nature & Scope: Key Working Relationships <ul><li>Internal contacts within client </li></ul>Global & Regional Team <ul><li>QA from R&D </li></ul><ul><li>Procedural & Process Management Network </li></ul><ul><li>Global LMS Administrator </li></ul><ul><li>Global PV enabling team </li></ul>Local Team <ul><li>Local Study Team Leaders and Local Study Team Members – Evidence Generation, China MA </li></ul><ul><li>GxP QMS, China MA </li></ul><ul><li>Head of Evidence Generation, China MA </li></ul><ul><li>Pharmacovigilance Personnel, China MA </li></ul><ul><li>Medical Excellence Manager, China MA </li></ul><ul><li>QC team member </li></ul><ul><li>External contacts with organizations outside client </li></ul><ul><li>Study team staff of Contract Research Organization </li></ul><ul><li>Study site staff </li></ul> Job requirements Acts Decisively <ul><li>Makes Effective Decisions Under Pressure: individual still makes effective decisions and can do so in the absence of complete information and when under pressure. </li></ul>Works Collaboratively <ul><li>Respects and Integrates Diverse Views: individual seeks input and demonstrates an appreciation for diverse views by incorporating them into decisions/ proposals. </li></ul>Results driven behavior <ul><li>Always maintain a focus on the objectives and anticipated outcomes of the clinical trial, ensuring that all components are effectively advanced to meet the established goals. </li><li>Adapt work strategies and plans with flexibility in response to trial progress and feedback on outcomes. Enhance the trial process to improve both efficiency and quality. </li></ul>Establish robust alliances with both internal and external stakeholders <ul><li>Establish and maintain close collaborative relationships with internal team members. Foster effective communication and collaboration among team members to facilitate the smooth progression of the trial. </li></ul><ul><li>Ensure consistent communication and coordination with external stakeholders. </li></ul><ul><li>Exhibit good teamwork and coordination skills in cross-departmental and inter-institutional collaborations. </li></ul>Self-motivation and adaptability <ul><li>Demonstrate a sense of self-motivation, exhibiting the capacity to actively and enthusiastically engage in clinical trial work. Be able to devise effective solutions for the complex and dynamic situations in clinical trials. </li></ul><ul><li>Demonstrate a commitment to continuous learning and skill acquisition to adapt to the ever-evolving landscape of clinical trial regulations and technologies. </li></ul> Academic / Professional Qualification <ul><li>Bachelor degree or above of medical/pharmaceutical background </li></ul> Working experience (No. of years / Job function / Business types) Essential <ul><li>At least 2 years working experience in clinical trial </li></ul><ul><li>At least 2 years quality management relevant experience </li></ul> <ul><li>At least 1 year proven training or coaching experience </li></ul>Desirable <ul><li>Procedural documents development experience </li></ul><ul><li>Clinical research experience within multinational pharmaceutical companies.</li></ul> COMPETENCIES (Skill / Knowledge / Technical / Training requirements) Skill <ul><li>Learning agility: swiftly acquire new knowledge and skills and apply effectively in practical works. </li></ul><ul><li>Presentation skills: confidently and fluently delivering training. </li></ul>Knowledge <ul><li>Experience of quality management in clinical trial </li></ul><ul><li>Excellent competence of GCP and clinical study procedure or pharmacovigilance </li></ul>Language ability <ul><li>Fluent oral and written English is essential. </li></ul>Computer literacy <ul><li>Proficient in the Microsoft Office software </li></ul> DUTIES & RESPONSIBILITES: Study onsite and remote QC activities <ul><li>Conduct onsite QC and remote QC as per QC plan requirement. </li></ul><ul><li>Draft related QC Report within timeline and keep the quality observations be notified to CPM and QC head. </li></ul><ul><li>Provide suggestion of CAPA and have a follow up if needed. </li></ul><ul><li>Conduct TMF quality checks for studies with documentation as per QC plan. </li></ul><ul><li>Conduct study level QC if needed (e.g., safety handling QC, HGR QC, etc.) </li></ul> Training delivery/support <ul><li>Lead/support the NEO training </li></ul><ul><li>Deliver /support the routine training/on-demand training for EvGen teams which are to emphasize the procedural key points or the update of global/local procedures. </li></ul><ul><li>Organize learning from QC checking, Audit and inspection for study teams which is aimed at increasing study team capability for study delivery. </li></ul>Supporting Audits & Inspections readiness <ul><li>Manage and supports activities during the preparation/ongoing/follow up phase of an audit or inspection. </li></ul><ul><li>Support finding management in VQV, CAPA development and implementation. </li></ul><ul><li>Case Sharing of results and training of local project team, if required. </li></ul>Vendor Management <ul><li>Coordinator the Operational Due Diligence (ODD) activity. </li></ul><ul><li>Support the vendor ODD by third party and follow the CAPA implementation status if needed. </li></ul><ul><li>Conduct the periodic vendor performance assessment and follow up with related CAPAs. </li></ul>SUSAR Line Listing management <ul><li>Sampling check to ensure the accuracy of monthly SUSAR line listing translation from third party </li></ul><ul><li>Delivery the qualified monthly SUSAR line listing to the project team in time. </li></ul>Other <ul><li>Keep compliance with regulatory, industry, client standard/policy and SOP requirements. </li></ul><ul><li>Complete other tasks assigned by QC head. </li><li></li></ul>

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Common Interview Questions And Answers

1. HOW DO YOU PLAN YOUR DAY?

This is what this question poses: When do you focus and start working seriously? What are the hours you work optimally? Are you a night owl? A morning bird? Remote teams can be made up of people working on different shifts and around the world, so you won't necessarily be stuck in the 9-5 schedule if it's not for you...

2. HOW DO YOU USE THE DIFFERENT COMMUNICATION TOOLS IN DIFFERENT SITUATIONS?

When you're working on a remote team, there's no way to chat in the hallway between meetings or catch up on the latest project during an office carpool. Therefore, virtual communication will be absolutely essential to get your work done...

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With this question, companies are looking to see what equipment they may need to provide you with and to verify how aware you are of what remote working could mean for you physically and logistically...

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Several years ago, I was working in a team to plan a big event. My supervisor made us all work as a team before the big day. One of our activities has been to find out how each of us processes information...

6. HOW DO YOU MANAGE THE CALENDAR AND THE PROGRAM? WHICH APPLICATIONS / SYSTEM DO YOU USE?

Or you may receive even more specific questions, such as: What's on your calendar? Do you plan blocks of time to do certain types of work? Do you have an open calendar that everyone can see?...

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Just like your schedule, how you track files and other information is very important. After all, everything is digital!...

8. HOW TO PRIORITIZE WORK?

The day I watched Marie Forleo's film separating the important from the urgent, my life changed. Not all remote jobs start fast, but most of them are...

9. HOW DO YOU PREPARE FOR A MEETING AND PREPARE A MEETING? WHAT DO YOU SEE HAPPENING DURING THE MEETING?

Just as communication is essential when working remotely, so is organization. Because you won't have those opportunities in the elevator or a casual conversation in the lunchroom, you should take advantage of the little time you have in a video or phone conference...

10. HOW DO YOU USE TECHNOLOGY ON A DAILY BASIS, IN YOUR WORK AND FOR YOUR PLEASURE?

This is a great question because it shows your comfort level with technology, which is very important for a remote worker because you will be working with technology over time...

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