Director, Operational Readiness CQV

Director Operational Readiness

Position Summary

CRB is looking for an energetic self-motivated individual for the role of Director Operational Readiness. The Director will lead cross-functional teams in the integration and delivery of Operational Readiness services (Turnover CQV and Startup Operations) on capital projects for our Life Science Food & Beverage Semi-Conductor and Data Center clients. Their main focus will be to become a business partner with Clients in achieving a Make Product Faster mindset which enables licensable facilities to be production online sooner utilizing risk-based and lifecycle methodologies. This role will also include helping clients navigate through regulatory requirements devising and executing strategies that meets timelines and assessing / mitigating risk all while driving leaner processes to achieve the end goal. The Director will provide oversight guidance and team formation for all regional projects from business development to proposal stage to facility turnover. This position requires a high level of organization communication and leadership; and the qualified candidate will have excellent interpersonal skills with internal and external clients.  They will represent CRB in a professional manner assist in winning work and understand how their strategy directly impacts our collective success.

Responsibilities

• Maintain PL responsibilities for business team and accountable to achieve Regional Team Revenue and Profit goals
• Coordinate / collaborate with Regional leadership in business development and account management on Market Focus Trends and developing New Client Solutions
• Lead and Support the Operational Readiness approach internally and externally with clients Design Operations Quality and Regulatory teams
• Manage regulatory reviews be part of operational design reviews develop overall risk-based approach for testing / documentation
• Active management of internal and / or external Operational Readiness resources on projects
• Lead the development of specific Turnover Operation and CQV plans to ensure integration with design automation and construction plans
• Work with Construction and Digital Innovation to deliver streamlined data management across various platforms
• Manage our partners and / or build a group to execute the integrated delivery strategy
• Develop and maintain relationships with ley stakeholders for successful projection execution
• Collaborate / Support the Digital Innovation team in the delivery of project data to Clients using best practices and AI integration
• Future assist in regulatory filings and agency reviews; operational training / staffing for clients
• Knowledge of US FDA (21 CFR) ISO 9001 and EU EMEA regulations
• Knowledge of primary industry guidance on CQV and CSV including but not limited to :

ISPE Baseline Guide 5 Commissioning and Qualification edition 2

Qualifications :

Additional Information :

All your information will be kept confidential according to EEO guidelines.

CRB is committed to hiring and retaining a diverse workforce. We are proud to be an Equal Opportunity / Affirmative Action Employer and it is our policy to provide equal opportunity to all people without regard to race color religion national origin ancestry marital status veteran status age disability pregnancy genetic information citizenship status sex sexual orientation gender identity or any other legally protected category. Employment is contingent on background screening.

CRB does not accept unsolicited resumes from search firms or agencies. Any resume submitted to any employee of CRB without a prior written search agreement will be considered unsolicited and the property of CRB. Please no phone calls or emails.

CRB offers a complete and competitive benefit package designed to meet individual and family needs.

If you are unable to complete this application due to a disability contact this employer to ask for an accommodation or an alternative application process.

Remote Work : No

Employment Type : Full-time

Key Skills

Computer Science,Operational Risk Management,Risk Management,Six Sigma,Continuous Improvement,Lean,Process Improvement,Pricing,Customer Support,Alteryx,Kaizen,Project Management Lifecycle

Experience : years

Vacancy : 1