CAI

CQV Associate Director

CAI

full-time

Posted on:

Location Type: Hybrid

Location: United States

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Job Level

Senior

About the role

  • Acts as a recognized subject matter expert (SME) in CQV across multiple sites and projects.
  • Provides high-level consulting on best-in-class CQV practices, including risk-based approaches and program assessments.
  • Supports strategic project work as a door-opener or specialized expert.
  • Reports directly to the CQV Global Director and serves as a knowledge resource internally and externally.
  • Manages client relationships across multiple sites or projects.
  • Participates in or leads the initiation and early stages of billable CQV projects.
  • Oversees internal programs with cross-functional teams, including client personnel and contractors.
  • Drafts and reviews CQV proposals and estimates for clients.
  • Engages in forums, publishes articles, participates in committees, and influences guidance standards.
  • Builds and maintains a network of industry contacts to identify new opportunities and increase value to current clients.
  • Supports the proposal process and helps grow CAI's business pipeline.
  • Mentors employees and develops qualification and training materials.
  • Acts as an internal CQV knowledge base for teams across the globe.
  • Contributes to internal qualifications, knowledge sharing, and process improvements.
  • Advises on integrated commissioning and qualification strategies.
  • Implements QRM methodologies and assesses supplier qualifications.
  • Consults on facility, equipment, utility CQV methods, including automation integration.
  • Supports digital validation life cycle and strategies for accelerating project delivery and speed to market.

Requirements

  • BS or MS in a relevant science or engineering field, or equivalent
  • Seven (7) or more years in CQV SME or project manager for large CQV projects roles for life sciences.  Demonstrated success in leading your team to achieve defined goals.
  • Excellent oral and written communication skills in English
  • Excellent skill in leading teams to perform complex tasks under pressure.
  • Excellent problem-solving skills
  • Customer-service focused.
  • Proficient in life science manufacturing processes in areas such as biotech, aseptic fill/finish, OSD, Gene Therapy or equivalent experience.
  • Able to travel domestically and internationally will be required. There will be significant travel to the US as part of this role.
Benefits
  • We are an equal opportunity employer; we are proud to employ veterans and promote a diverse culture in our workplace. Diversity is a strength for our global company.

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills
CQVrisk-based approachesprogram assessmentsintegrated commissioningqualification strategiesQRM methodologiesautomation integrationdigital validation life cyclelife science manufacturing processesbiotech
Soft skills
communication skillsteam leadershipproblem-solvingcustomer servicementoringrelationship managementknowledge sharingprocess improvementnetworkingconsulting
Certifications
BS in science or engineeringMS in science or engineering