Director, Quality Assurance and Regulatory Affairs(GCP, Clinical Research Digital Solution)-Evinova China
At Evinova, weput patients first and strive to meettheirunmetneedsworldwide. Workingheremeansbeingentrepreneurial, thinkingbig, and workingtogether to make the impossible a reality. If youareswift to action, confident to lead, willing to collaborate, and curiousaboutwhat science can do, thenyou’reour kind of person.
Evinova is a health-tech business, separatecompanywithin the AstraZeneca Group, accelerating the deliveryofbetterhealthoutcomes by propelling the lifesciencessector forward in digital health, from the inside. Throughourapplicationof science-basedexpertise, evidence-led rigor, and human experience-driven insight, our digital solutions aredeliberatelycrafted so thateveryonecanreachbetterhealthoutcomestogether.
Thisindividualwillworkcloselywith theHeadofQuality, Compliance, and Audit and the GM of China to ensurethatoperationalactivitiesalignwithour global strategy and local market needs. The ideal candidatewillhave a strong background in business strategy, operations, financial planning, and investor relations, with a proven ability to thrive in fast-paced, high-growthenvironments.
The Directorof Quality Assurance and Regulatory Affairs (QARA)willlead the regulatoryaffairs, qualityassurance, and auditprocessesfor our business in China.Youwillaid in the management customeraudits, software qualification and regulatorycompliancelocally in China. This is a pivotalrolethatensuresourproductmeetslocalregulatory standards and supportsourcontinuedgrowth in China market.The ideal candidatewillhave robust experiencenavigatingChina’sregulatory landscape while collaborating with global teams to maintain a consistent standard ofexcellence.
KeyResponsibilities:
Overseeand drive the qualificationofplatformand softwareproducts for China market.
Ensure all software and digital solutions adhere to bothChinese and internationalregulationsand standards.
Collaboratewith global and local teams to align regulatory strategies and documentation.
Develop, implement, and continuouslyimprovequalityassuranceprocessestailored for the digital clinical research environment under the directionof the HeadofQuality, Compliance, & Audit.
Establish regulatory strategies to support product releases, ensuring full compliancewithlocal and global standards.
Manageand monitor the executionofqualitycontrolprotocolsacross all stagesofproductdevelopment and deployment.
LiaisewithChina regulatoryauthorities, certificationbodies, and otherpartners to ensuretimely and successfulproductapprovals.
Partner withLegal supportdata privacycompliance and run Cross-Border Data Transfer (CBDT) initiatives in alignmentwith Chinaregulations.
Stayupdated on regulatorychanges and ensure the organizationadapts to new compliancerequirementseffectively.
Develop and implement a comprehensiveauditprogram for Chinafittinginto the Global QA Plan to proactivelyidentify and mitigate risks.
Act as a subjectmatter expert on qualityassurance and regulatory affairs, advisinginternalcustomers on best practicesspecific to the China market.
Workcloselywith global teams, localtechnical experts, product managers, and legal advisors to harmonizeregulatory and qualityinitiatives.
Provideregularreports, dashboards, and updates to the GM of China and the Global HeadofQuality, Compliance, and Audit on compliance status, auditoutcomes, and certification progress.
Collaborate with cross-functional teams to integrate QARA standard methodologies into broader business operations.
Continuouslyevaluate and improvequalityassuranceprocesses to meetevolving regulatory requirementsand businessneeds.
Champion industry best practices in qualityassurance and regulatoryaffairs, encouraging a cultureofexcellenceand innovation.
Required Experience/Qualifications:
Bachelor’sdegree in Life Sciences, Engineering, Quality Management, RegulatoryAffairs, or arelatedfield; advanceddegree (Master’s/PhD) ispreferred.
8+yearsofexperience in qualityassurance and regulatoryaffairsin the pharmaceutical or CROindustry, withrobust understandingofDrugDevelopmentProcesses and ClincalTrials.
Provenexpertise and success in managing regulatory compliance, qualityassuranceprocesses, and audit programs in China.
In-depthknowledgeofChina regulatory requirements, including ICP filing, MLPS certification, data privacy,CBDT, PIPL, etcregulations.
In-depthknowledgeof the China pharmaceutical R&D market, particularly inclinicalresearchand GCP practice.
Previousauditexperience in life scienceindustry.
Confirmed ability to workeffectively in a global, matrixedenvironment, collaboratingwith cross-border teams and customers.
Strong leadership, project management, and communication skills, with the ability to drive critical initiatives and encourage cross-functional teams.
Proven track record to leadcomplexprojects in a fast-paced, high-growthenvironment.
Meticulouswith strong analytical and troubleshootingskills.
Fluent English and Mandarin, bothcan be used as workinglanguage
Why Evinova (AstraZeneca)?
Evinovadraws on AstraZeneca’sdeepexperiencedevelopingnoveltherapeutics, informed by insights from thousandsof patients and clinical researchers. Together, wecanaccelerate the deliveryoflife-changingmedicines, improve the design anddeliveryofclinicaltrials for better patient experiences and outcomes, and thinkmoreholisticallyabout patient carebefore, during, and aftertreatment. Weknowthat regulators, healthcareprofessionals, and care teams at clinicaltrial sites do not want a fragmented approach. They do not want a futurewhereeverypharmaceuticalcompanyprovidesitsown, different digital solutions. Theywant solutions thatworkacross the sector, simplifytheirworkload, and benefit patients broadly. By bringingour solutions to the widerhealthcarecommunity, wecanhelpbuildmoreunifiedapproaches to howwe all develop and deploy digital technologies, betterservingour teams, physicians, and ultimately patients. Evinovarepresents a uniqueopportunity to delivermeaningfuloutcomeswith digital and AI to serve the widerhealthcarecommunity and createnew standards for the sector. Joinus on ourjourneyofbuilding a new kind ofhealthtech business to resetexpectationsofwhat a bio-pharmaceuticalcompanycan be. Thismeanswe’reopening new ways to work, pioneeringcutting-edgemethods, and bringingunexpected teams together.
Location: Shanghai China
Salary: Competitive + Excellent Benefits!
So, what’snext?
Areyoualreadyimaginingyourselfjoiningour team? Good, becausewecan’twait to hear from you!
Wherecan I findoutmore?
Our Social Media, FollowEvinova on LinkedIn https://www.linkedin.com/company/evinova/
LearnmoreaboutEvinovawww.evinova.com
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.
