QC Manager (FSP)

When our values align theres no limit to what we can achieve.

At Parexel we all share the same goal - to improve the worlds 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 were committed to making a difference.

Job Nature & Scope:

Key Working Relationships

• Internal contacts within client

Global & Regional Team

• QA from R&D

• Procedural & Process Management Network

• Global LMS Administrator

• Global PV enabling team

Local Team

• Local Study Team Leaders and Local Study Team Members Evidence Generation China MA

• GxP QMS China MA

• Head of Evidence Generation China MA

• Pharmacovigilance Personnel China MA

• Medical Excellence Manager China MA

• QC team member

• External contacts with organizations outside client

• Study team staff of Contract Research Organization

• Study site staff

Job requirements

Acts Decisively

• Makes Effective Decisions Under Pressure: individualstill makes effective decisions and can do so in the absence of complete information and when under pressure.

Works Collaboratively

• Respects and Integrates Diverse Views: individual seeks input anddemonstratesan appreciation for diverse views by incorporating them into decisions/ proposals.

Results driven behavior

• Alwaysmaintaina focus on theobjectivesand anticipated outcomes of the clinical trial ensuring that all components are effectively advanced to meet the established goals.

• Adapt work strategies and plans with flexibility in response to trial progress and feedback on the trial process to improve both efficiency and quality.

Establish robust alliances with both internal and external stakeholders

• Establish andmaintainclose collaborative relationships with internal team members. Foster effective communication and collaboration among team members tofacilitatethe smooth progression of the trial.

• Ensure consistent communication and coordination with external stakeholders.

• Exhibit good teamwork and coordination skills in cross-departmental and inter-institutional collaborations.

Self-motivation and adaptability

• Demonstrate a sense of self-motivationexhibitingthe capacity toactively and enthusiastically engage in clinical trial work. Be able to devise effective solutions for the complex and dynamic situations in clinical trials.

• Demonstrate a commitment to continuous learning and skill acquisition to adapt to the ever-evolving landscape of clinical trial regulations and technologies.

Academic / ProfessionalQualification

• Bachelor degree or above of medical/pharmaceuticalbackground

Working experience (No. of years/Job function/Business types)

Essential

• At least2yearsworking experience in clinical trial

• At least 2 yearsquality managementrelevantexperience

• At least1 yearproven training or coaching experience

Desirable

• Procedural documentsdevelopmentexperience

• Clinical research experience within multinational pharmaceutical companies.

COMPETENCIES(Skill/ Knowledge /Technical /Trainingrequirements)

Skill

• Learningagility:swiftly acquire new knowledge and skillsandapply effectively in practicalworks.

• Presentationskills: confidently and fluently deliveringtraining.

Knowledge

• Experience of quality management in clinical trial

• Excellent competence of GCP and clinical study procedureorpharmacovigilance

Language ability

• Fluent oral and written English is essential.

Computer literacy

• Proficient in the Microsoft Officesoftware

DUTIES & RESPONSIBILITES:

Studyonsite and remoteQCactivities

• Conductonsite QC and remoteQCas per QC plan requirement.

• Draft related QCReportwithin timelineandkeep the qualityobservationsbe notifiedto CPM and QChead.

• ProvidesuggestionofCAPA and have a follow up if needed.

• Conduct TMF quality checks for studieswith documentation as per QC plan.

• Conduct study level QC if needed (e.g. safety handling QC HGR QC etc.)

Trainingdelivery/support

• Lead/support the NEO training

• Deliver/support theroutine training/on-demand trainingfor EvGen teamswhich are to emphasize the procedural key points or the update of global/local procedures.

• Organize learning from QC checking Audit and inspection for study teams which is aimed at increasing study team capabilityfor studydelivery.

Supporting Audits & Inspections readiness

• Manage andsupportsactivities during the preparation/ongoing/follow up phase of an audit orinspection.

• Support finding management in VQV CAPAdevelopmentandimplementation.

• Case Sharing of results and training of local project team ifrequired.

Vendor Management

• Coordinatorthe Operational Due Diligence (ODD) activity.

• Supportthevendor ODDby thirdparty andfollowtheCAPAimplementation status if needed.

• Conduct the periodic vendor performance assessmentandfollow up with related CAPAs.

SUSAR Line Listingmanagement

• Sampling check toensure the accuracy of monthly SUSAR line listing translation fromthirdparty

• Delivery the qualified monthly SUSAR line listing to the project team in time.

Other

• Keep compliance with regulatory industryclientstandard/policyand SOP requirements.

• Complete other tasks assigned by QC head.