Associate Director Functional Quality Business Partner RDQuality

4 days ago

mon, India TekWissen LLC Full time
Overview : TekWissen Group is a workforce management providerthroughout the USA and many other countries in the world. The belowjob opportunity is with one of our Biotech clients who researchesdevelop and commercializes drugs. The company focuses primarily onantiviral drugs used in the treatment of HIV hepatitis B hepatitisC and influenza including Harvoni and Sovaldi.
Position: AssociateDirector Functional Quality Business Partner R&D Quality Location: Foster City CA 94404 Duration: 12 Months Job Type: Contract Work Type: Hybrid Job Description POSITION OVERVIEW:
  • You will act as the R&D Quality BusinessPartner to assigned groups such as client R&D functions orvendors supporting client R&D.
  • You will provide strategic expert advice andconsultation on R&D quality risk and continuous improvementwith impact across crossfunctional Good Clinical Practices (GCP).
  • You will educateassigned groups on client quality policy and procedural standardsGCP regulations and other requirements.
  • You will provide expert advice on GCP riskminimization and mitigation.
  • You will help the business understand potential impactsof risk and alternatives to best address risk.
  • You will also provide leadershipsupport in escalating quality risks or issues.
  • You will participate in Qualityforums crossfunctional teams and/or projects.
  • You will act as the central pointof contact for QMSrelated communications to assigned groups;consolidating and channeling justintime information and resourcesto assist assigned groups.
  • You will collaborate with other R&D Quality groupsto ensure justintime support and resources to assigned groupsincluding data reporting training audit inspection risk assessmentand deviation/ CAPA management support.
  • You may support client during regulatoryinspections.
EXAMPLE RESPONSIBILITIES:
  • Serves as Quality Business Partner lead forassigned client R&D functions programs and/or vendors.
  • Handles multipleprojects simultaneously and ensures overall and timely completionof tasks.
  • Worksclosely with business to provide expert quality information manageidentified issues and support continuous improvement.
  • Acts as Subject Matter Expertsupporting GCP cross portfolio risk assessment for all activitiesperformed by assigned functions vendors or relevant to assignedR&D programs.
  • Collaborates with the Audit Inspection and CAPAManagement Team within R&D Quality as required on internalquality audits regulatory agency inspections risk assessmentdeviations and CAPA activities.
  • Assists in readiness preparation and/or directlysupports regulatory agency inspection.
  • Supports deviation identification reportingand CAPA development.
  • Supports evaluation of new regulations and potentialimplications for client R&D and/or R&D vendors.
  • Evaluates writesand/or reviews standard operating procedures and performs otheractivities in support of an integrated crossfunctional QMS.
  • Collaborates withother R&D Quality teams to ensure assigned functions programsor vendors have timely and robust support for quality data/analytics and reporting quality documentation and training qualitytechnology and systems validation and other related activities.
  • May lead or supportprojects.
  • Ensuresown work complies with established practices policies and processesand any regulatory or other requirements.
REQUIREMENTS:
  • Education& Experience
  • PharmD/PhD with 2 years experience.
  • MA/MS/MBA with 8 years relevant experience.
  • BA/BS with 10 yearsrelevant experience.
  • Significant experience advising business functions inthe biopharma industry on GCP quality and compliance requirementsevolving regulations risk minimization and mitigation andcontinuous improvement.
  • Previous GCP quality experience at a Sponsor or CRO;Previous experience as an auditor highly desired.
  • Experience working across a broadspectrum of quality and/or compliance activities includingauthoring and reviewing SOPs conducting internal auditingsupporting regulatory inspections developing and managing CAPAs anddeviations and training others on quality and/or compliancerequirements.
  • Significant experience participating in crossfunctionalprojects and teams with responsibilities related to clinical trialsor other drug development activities.
  • Experience working with total qualitymanagement methodologies such as Lean Six Sigma is a plus.
Knowledge & Other Requirements
  • Thorough knowledge of standards systemspolicies and procedures that enable Good Clinical Practices (GCP)QMS operations and compliance within the biopharma industry.Experience with Good Clinical Laboratory Practices (GCLP) GoodPharmacovigilance (GVP) and Electronic Systems Compliance (ESC) isa plus.
  • Thoroughknowledge of the drug development process including all keyfunctions involved in the various stages of drug development fromearly research through postmarketing.
  • Demonstrates advanced business knowledge andanalytical skills as evidenced by strengths in assessing complexsystems and data and understanding the quality and complianceimplications.
  • Strongleadership presence with demonstrated ability to lead withoutauthority and influence programs projects and/or initiatives.
  • Strong interpersonalskills and understanding of team dynamics.
  • Strong communication and organizationalskills.
  • Strongnegotiation and conflict resolution skills.
TekWissen Group is an equal opportunityemployer supporting workforce diversity.

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