CQV Associate Director overseeing multiple CQV projects and providing subject matter expertise. Building client relationships and supporting strategic project engagements in life sciences.
Responsibilities
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.
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