Advarra

Manager

• Lead and develop a team of 2-8 Product Support Specialists delivering Tier 1, 2 or 3 support across multiple channels.
• Provide technical and subject matter leadership across the supported product ecosystem.
• Conduct regular 1:1s, set performance goals, deliver coaching, and drive professional development.
• Monitor queue health, SLA performance, quality standards, and workload distribution; adjust resources and step-in directly to meet operational targets.
• Serve as an internal escalation point for complex or high-impact customer issues.
• Partner with Product Management and Engineering as the Voice of the Customer, escalating trends, enhancement requests, and systemic issues.
• Act as liaison between customers and development teams to support requirements gathering, product feedback, and validation efforts.
• Identify and implement process improvements to enhance team efficiency, quality, and customer experience.
• Support recruiting, onboarding, and training of new team members.
• Maintain an active caseload, providing direct Tier 1, 2 or 3 support and ensure timely, high-quality resolutions.
• Lead resolution of complex, cross-functional issues, coordinating with internal stakeholders to drive outcomes.
• Diagnose and troubleshoot technical and workflow-related issues; communicate solutions clearly and provide customer training as needed.
• Research and collaborate with internal teams when solutions are not immediately available.
• Develop trusted customer relationships by understanding operational goals and recommending workflow optimizations and expanded product functionality.
• Serve as a product expert across supported applications and integrations, maintaining up-to-date knowledge of system changes and enhancements.

Associate Manager, Product Support

Customer Success Manager

• Support the BD Team in the RFI/RFP process
• Follow the Client Onboarding Framework to ensure client expectations are satisfied
• Conduct CIRBI demonstrations
• Provide ongoing CIRBI support and training
• Proactively manage transition of new studies to the assigned CSC team
• Establish periodic check-ins to monitor client satisfaction

Client Success Director

• Support the BD Team in the RFI/RFP process
• Follow the Client Onboarding Framework to ensure client expectations are satisfied and goals are achieved
• Establish and document client-specific processes and documentation requirements
• Conduct CIRBI demonstrations, highlighting features and functions that support efficiency from study start-up through study closure
• Provide ongoing CIRBI support and training
• Coordinate specific or unique requirements with assigned Client Service Coordinators through primary interaction with managers/leads of such teams
• Proactively manage transition of new studies to the assigned CSC team, including introductions, setting expectations, and establishing escalation pathway
• Further existing strategies to increase revenue and profitability from existing customers
• Establish periodic check-ins to monitor client satisfaction and client outcomes
• Facilitate resolution/alternative to any client dissatisfaction with Advarra
• Ensure clients are receiving consistent quality of service through the establishment of Client Engagement policies

QA Engineer

• Approve the final quality of Investigational Medicinal Products (IMPs)
• Review and approve compliance with all mandatory requirements, including Manufacturing Batch Records, Environmental Monitoring (EM), Media Fills, deviations/violations/out-of-specification (OOS) events and corrective and preventive actions, packaging and labeling, drug release, distribution, and temperature control (in-transit and storage)
• Lead and manage all quality-related communications with regulatory authorities
• Explain the sponsor’s quality system and release decision processes during regulatory inspections (e.g., EMA, FDA)
• Provide scientific justification for the sterile product risk management framework within the Contamination Control Strategy (CCS) in accordance with Annex 1
• Ensure compliance with the Pharmaceutical Quality System (PQS) according to International Council for Harmonisation (ICH Q10) guidelines
• Provide appropriate quality oversight of Contract Manufacturing Organizations (CMOs)
• Approve change controls and Corrective and Preventative Actions (CAPAs)
• Conduct quality risk assessments

Quality Assurance – Manufacturing, GMP, CMC, Aseptic

Auditor

• Conduct Good Pharmacovigilance Practice (GVP) audits (planning, agenda, physical or remote audit, and report writing)
• Evaluate investigator sites, CROs, and vendor compliance or qualification.
• Prepare comprehensive audit reports detailing findings and root-causes.
• Provide written audit reports in English.
• If required will provide corrective actions support and present findings to QA leadership and stakeholders
• Work collaboratively with clients to ensure quality standards.

Pharmaceutical Quality GVP Auditor – Freelance/Independent Consulting

• Conduct Good Clinical Practice (GCP) audits (planning, agenda, physical or remote audit, and report writing)
• Evaluate investigator sites, CROs, and vendor compliance or qualification.
• Prepare comprehensive audit reports detailing findings and root-causes.
• Provide written audit reports in English.
• If required will provide corrective actions support and present findings to QA leadership and stakeholders
• Work collaboratively with clients to ensure quality standards.

Pharmaceutical Quality GCP Auditor – Consulting

• Conduct Good Manufacturing Practice (GMP) audits (planning, agenda, physical or remote audit, and report writing)
• Evaluate investigator sites, CROs, and vendor compliance or qualification.
• Prepare comprehensive audit reports detailing findings and root-causes.
• Provide written audit reports in English.
• If required will provide corrective actions support and present findings to QA leadership and stakeholders
• Work collaboratively with clients to ensure quality standards.

Pharmaceutical Quality GMP Auditor – Consulting

• Conduct Good Clinical Practice (GCP) audits (planning, agenda, physical or remote audit, and report writing)
• Evaluate investigator sites, CROs, and vendor compliance or qualification
• Prepare comprehensive audit reports detailing findings and root-causes
• Provide written audit reports in English

Pharmaceutical Quality GCP Auditor, Consulting

Pharmaceutical Quality GCP Auditor – Independent/Freelance

• Partner with commercial, Clinical Science, Ops and Product Teams to translate sold proposals into clearly defined scope of work, delivery approach, assumptions, dependencies and documented deliverables.
• Validate feasibility of timelines, data inputs, and analytics prior to executive.
• Lead end to end customer onboarding including implementation planning, configuration, data readiness, setup, and product adoption.
• Serve as the primary contact during activation and guide customers on workflow integration and use of Study Design solutions.
• Manage multi-workstream customer projects by developing and maintaining detailed project plans, milestones, dependencies and risk across cross functional teams.
• Drive data onboarding and validation of workflows and support customers in enabling platform capabilities, including Databricks based processes.
• Establish delivery of governance, progress tracking, and escalation paths to ensure predictable execution.
• Serve as the primary owner of scope integrity by managing client expectations, evaluating change requests, and aligning any scope modifications with commercial and internal delivery teams to prevent delivery risk and scope creep.
• Support commercial engagement by maintaining strong handoff routines, aligning implementation plans to business objectives, and providing value evidence that supports renewal and expansion.
• Manage strategic partnership engagement for AI powered services and products by coordinating onboarding, integration activities, shared deliverables, and communication rhythms.
• Support late-stage sales, renewals, and expansions by advising on delivery approach, timelines, data requirements and feasibility of proposed Study Design Insights.
• Oversee operational construct for Advarra’s Thought Leadership Council, including agenda planning, content coordination, member engagement, and follow up actions.
• Ensure council outputs inform product strategy and contribute to Advarra’s industry leadership.
• Act as a cross-functional connector by surfacing customer and partner insights and helping teams refine delivery processes and engagement models.

Implementation, Customer Success Manager – AI & Innovations

Customer Support

• Provide support via e-mail, Chat, or ticket system to respond to inquiries and troubleshoot complex issues.
• Become proficient in core applications in the Advarra product suite, their points of integration, and what problems each product solves for a given customer.
• Facilitate troubleshooting and communication across multiple teams to provide customers with effective solutions quickly.

Product Support Specialist II

• Lead and develop a team of 2-8 Product Support Specialists delivering Tier 1, 2 or 3 support across multiple channels.
• Provide technical and subject matter leadership across the supported product ecosystem.
• Conduct regular 1:1s, set performance goals, deliver coaching, and drive professional development.
• Monitor queue health, SLA performance, quality standards, and workload distribution; adjust resources and step-in directly to meet operational targets.
• Serve as an internal escalation point for complex or high-impact customer issues.
• Partner with Product Management and Engineering as the Voice of the Customer, escalating trends, enhancement requests, and systemic issues.
• Act as liaison between customers and development teams to support requirements gathering, product feedback, and validation efforts.
• Identify and implement process improvements to enhance team efficiency, quality, and customer experience.
• Support recruiting, onboarding, and training of new team members.
• Maintain an active caseload, providing direct Tier 1, 2 or 3 support and ensure timely, high-quality resolutions.
• Lead resolution of complex, cross-functional issues, coordinating with internal stakeholders to drive outcomes.
• Diagnose and troubleshoot technical and workflow-related issues; communicate solutions clearly and provide customer training as needed.
• Research and collaborate with internal teams when solutions are not immediately available.
• Develop trusted customer relationships by understanding operational goals and recommending workflow optimizations and expanded product functionality.
• Serve as a product expert across supported applications and integrations, maintaining up-to-date knowledge of system changes and enhancements.
• Demonstrate urgency, accountability, and professionalism in all client interactions.
• Work independently and integrate into a team environment

Systems Engineer

• Follow and optimize Business Systems processes, SOPs and SLAs.
• Elicit requirements utilizing various techniques: interviews, document analysis, requirements workshops, surveys, business process flows, use cases, and end user task and workflow analysis.
• Proactively identify and define system improvements, enhancements, and customizations to meet business needs.

Business Systems Analyst

• Follow and optimize Business Systems processes, SOPs and SLAs.
• Demonstrate key business analysis skills: elicit requirements utilizing various techniques, to include: interviews, document analysis, requirements workshops, surveys, business process flows, use cases, and end user task and workflow analysis.
• Exhibit a strong customer-centered mindset with attention to process and system improvements to drive business outcomes.
• Support team accountability for promised deliverables, project progress, successes, and failures.
• Collaboratively share insights with peers and colleagues.
• Escalate and qualify issues and risks related to work items, systems, or existing processes.
• Understand, quantify and communicate business relevance and value to business teams.
• Proactively identify and define system improvements, enhancements, and customizations to meet business needs.
• Perform other job-related duties as assigned.

Full-stack Engineer

• Architect and lead implementation of AI-powered features within Product & Technology applications.
• Provide hands-on technical leadership in system design, model integration strategies, prompt engineering, retrieval-augmented generation (RAG), and AI orchestration patterns.
• Evaluate and guide selection of AI tools, services, and platforms based on performance, scalability, cost, compliance, and long-term maintainability.
• Establish governance standards for responsible AI usage.
• Partner with Product Management to convert AI use cases into executable technical plans.
• Lead the implementation of AI assistants and automation across engineering workflows.
• Define operational guardrails and usage standards.
• Track and report measurable improvements.
• Lead multiple agile engineering teams with clear accountability for roadmap execution.
• Contribute to budgeting discussions, vendor evaluations, and cost optimization strategies.

Associate Manager, Product Support

Client Success Director

Client Success Director

Quality Assurance – Manufacturing, GMP, CMC, Aseptic

Pharmaceutical Quality GVP Auditor – Freelance/Independent Consulting

Pharmaceutical Quality GCP Auditor – Consulting

Pharmaceutical Quality GMP Auditor – Consulting

Pharmaceutical Quality GCP Auditor, Consulting

Pharmaceutical Quality GCP Auditor – Independent/Freelance

Implementation, Customer Success Manager – AI & Innovations

Product Support Specialist II

Associate Manager, Product Support

Business Systems Analyst

Business Systems Analyst

Director, Software Engineering – AI & Innovations