Senior Manager, Quality Systems & Platform Compliance
Company Description
About AbbVie AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us atwww.abbvie.com. Follow @abbvie onLinkedIn,Facebook,Instagram,XandYouTube.
Job Description
The Senior Manager of Quality System will reporttothe Director of Operations, Quality and Compliance withinthe Strategic Operations function of AbbVie Patient Services.This roleis responsible forsupporting theestablished Quality Management System,includingTraining, Document Management Systems,QualityProcessesutilizedacrossour patient support programs. In addition, this role willhaveBSOresponsibilitiesof the Quality & Compliance Platform(GxP)housed byapprovedthird partyto ensureinnovation,advancement of capabilities,reporting needs andalignment with functional program owners while ensuringSLC and Data Protection and Privacyenforcement. Responsibilities: - Be a champion ofestablishingthe environment of process and continuous improvement.Work to integrate quality into all we do in APS, including project management,metricsand performance review processes.
- TranslatingAPSPolicies, Proceduresand Approved Process into approved organizational training plans within approved LMS (ALC, Compliance Wire, LERN).
- Ownannual APS training plan and lead collaborative governance meetings withUSCommercial Compliance Training team.This includes ensuring functionalareas,PSP program ownersare appropriately assigned training, and enforcing on-time completion.
- Own PSP Experience and Insightsprocess, ensuringagileand efficient dashboard, reports andtemplatedprocesses are stood up to meet the needs of our functional areasand APS business aswhole.
- Ownership ofQuality PSP AIbasedprocess(i.e.QSautoscoring, call summaries,transcriptions, etc.)Includesoversight of current framework,reportingand continuous improvement of capabilities.Liaison between third-partyvendor, functionalteamsand BTS partnersto ensure collaboration, strong workingrelationshipsand delivery of capabilities.
- Provides oversight for the development and maintenance of quality programs, systems,processesand procedures that ensure complianceand cansupport D2D operational businessand program owners. This ensures good documentationpractice, as well as continuedknowledgemanagement ofimplemented processes.
- Business System Owner ofGxPapproved third-party housed quality & compliance platformand ensuring the following(but not limited to):
- Strategic oversight of third-party andall approved modules/sleevesof operations that are live, implemented and used within APS.
- Driving implementation ofinnovation,enhancements of BAU capabilities to meet the needs of functional partners.
- Ensuring data quality, reporting accuraciesper capabilities to ensure D2D use of platform and information isaccurate, compliant andmeetsAbbviecompliance and privacy framework.
- Ensuring platform is approved and has allappropriateand up to datedocumentation (i.e.ADCT, SET, ACTOR,TPSE,etc.)
- Collaborating with functional partners to translate needs into new capabilities that are user friendlyandmeetestablished business requirements.
- Ensure rigor of business requirements, testing androll-out of current and new features.
- Holdingapprovedthird partyvendoraccountable to established MSA, SOW and KPIthrough defined health checks, including published agendas andmeeting minutes.
- Work withoperations,quality&complianceteamtoensure theyare receivingappropriate supportto deliverdata and metrics related to performance read-outs,calibrationsand management reviews.
Qualifications
- Bachelor's degree required in a science related area.
- 5+ years of Quality Systems experience within the pharmaceutical industry withsome leadershipexperience and a demonstrated understanding of relevant regulations and standard operating procedures.
- This role requires strong organizational, strategic thinking, analytical and reporting skills, and strong understanding of the patient services and pharmaceutical business.
- Requires an in-depth understanding of the pharmaceutical patient centricity, customer service oriented, and quality systems.
- The position requires human relations and administrative skills necessary toestablishand maintain effective working relationships with team members,co-leadersand senior leadership in Commercial, Business Technology Services, Legal, OEC, Manufacturing Operations, Global Medical Affairs, Promotions, Brand teams, and Global Patient Services.
- The individual mustpossesssound judgment in evaluating andestablishingcompliance strategic plans as well as in day-to-day situations.
- Conflict resolution skills including persuasive management techniquesrequired.
- Excellent verbal, written, presentation and interpersonal skillsrequired. Ability to communicate concepts and problems in terms that are understandable to all levels of the organization, including senior leadership.
Additional Information
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state orlocal law: - The compensation range described below is the range of possible base pay compensation that the Companybelieves ingood faith it will pay for this role at the timeof this posting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographic location, andwemay ultimatelypay more or less than the posted range. This range may be modified in thefuture.
- We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),medical/dental/visioninsurance and 401(k) to eligibleemployees.
- This job is eligible to participate in our short-term incentiveprograms.
Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, anddeterminable.The amount and availability of any bonus,commission, incentive, benefits, or any other form ofcompensation and benefitsthat are allocable to a particular employee remains in the Company's sole andabsolutediscretion unless and until paid andmay be modified at the Companys sole and absolute discretion, consistent withapplicable law. AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visithttps://www.abbvie.com/join-us/equal-employment-opportunity-employer.html US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: https://www.abbvie.com/join-us/reasonable-accommodations.html
|