LabConnect

Proposal Manager

• Manage individual study quotation preparation processes and timelines
• Prepare quotations using the company’s pricing tools
• Obtain third-party vendor quotes from partner companies
• Participate in strategy calls and budget review calls
• Recommend desirable proposals based on financial and operational criteria
• Participate in cross-functional teams to improve quotation quality and timeliness
• Follow up with Business Development Directors to ensure proposals are complete and meet needs
• Assist with Business Development presentations
• Update the CRM database and maintain departmental information accuracy
• Act as an expert resource for internal and external customers
• Participate in Proposal Management initiatives
• Perform other related duties as assigned

Associate

• Prepare quotations for protocols, bid requests, study revisions, and additions using company pricing tools
• Complete budget-to-actual reconciliations at predetermined points during awarded studies
• Assist with recommendations on desirable proposals using financial and operational criteria
• Coordinate with Business Development Directors to ensure clinical study quotes address client needs
• Coordinate and facilitate quotation generation with staff and partner laboratories
• Assist with proposal tracking
• Update Salesforce and maintain accurate departmental information
• Manage low- to medium-complexity opportunities when required by the business unit or team
• Shadow or assist senior colleagues on medium- to high-complexity opportunities when required
• Participate in Business Operations departmental initiatives
• Assist with departmental reports
• Provide backup assistance for other departmental functions
• Perform other related duties as assigned

Proposal Associate II

Operations

• Develop and execute the annual US Quality Plan aligned with global strategy
• Provide oversight of US Quality Assurance operations and Global Quality Control
• Advise US Operations and senior leadership on quality strategy, regulatory requirements, and compliance risks
• Lead strategic projects that enhance quality culture and improve processes and outcomes
• Oversee design verification and quality control review processes
• Direct study QC support documentation reviews
• Establish and monitor US QA and Global QC metrics; report outcomes and recommend improvements
• Participate in quality-event investigations and CAPA planning
• Author, review, and approve Project Quality Control SOPs
• Coordinate and host client audits and prepare the organization for regulatory inspections
• Collaborate across departments to align QC reviews with current processes and standards
• Provide regulatory and compliance risk reviews of contractual negotiations
• Partner with global QA and IT staff on systems validation and compliance initiatives
• Supervise, coach, and develop Quality Control Specialists and other team members
• Oversee training-material creation and staff readiness for evolving quality standards
• Interface with laboratory, customer service, business development, project management, IT, and data management teams

Director, Quality Operations

QA Engineer

• Oversee Computer System Validation activities for newly implemented and modified systems throughout the software life cycle
• Collaborate with IT and system owners on validation strategies, documentation, and deliverables
• Plan and perform audits of IT and technology vendors
• Review audit findings and validation reports to assess compliance gaps and system risks
• Participate in root cause analysis sessions and approve effective CAPAs with cross-functional SMEs
• Assist with risk assessments of new and proposed technologies, including contributions to the AI advisory team
• Create and approve internal SOPs and processes for computerized systems, data integrity, and data privacy compliance
• Ensure documentation for CSV and Data Integrity projects, including risk control matrices, compliance assessments, process narratives, testing, issue evaluation, and reporting
• Manage day-to-day compliance operations, including client and vendor IT questionnaires, metrics reporting, audit finding responses, internal audits, and document reviews
• Conduct IT supplier qualification reviews
• Ensure lifecycle management of GxP computerized systems through QMS policies, documentation, and change control
• Prepare KPIs for management quality reporting and assist with Veeva Vault workflows, reporting, and configurations
• Identify and implement continuous quality improvement plans across computerized systems
• Monitor regulatory and IT compliance developments and best practices

Proposal Manager

Proposal Associate II

Director, Quality Operations

Senior Quality Assurance Specialist – Computer Systems, Data Integrity