Director, Operational Readiness CQV

CRB•Kansas City, NC

About The Position

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 Client’s 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.

Requirements

Bachelor’s Degree in Architecture, Engineering, Life Sciences, Construction Management, or similar degree preferred, or equivalent years of relevant industry experience.
Minimum of 15+ years of Commissioning, Qualification, Validation, Compliance, and Operations experience in the Life Science industry; Sound technical knowledge of both US and global regulatory requirements
Demonstrated effective leadership, financial management and collaboration skills.
Interpersonal and leadership skills necessary to communicate clearly, and effectively manage qualification/validation activities with all levels of personnel from various disciplines across the organization.
Direct experience in producing and managing commissioning, qualification, and operational deliverables.
Familiarity with all phases of design and construction required; direct experience in Life Sciences capital projects preferred.
Excellent organizational, interpersonal, presentation, and communication skills.
Commitment to technical excellence, as well as creating world-class experiences for our clients and employees.
Flexible and willing to travel as needed. Expectation of 50+% travel initially with eventual expectation of up to 25% travel, in support of client projects and regional leadership.
Knowledge of US FDA (21 CFR 210, 211, 810), 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 ISPE GAMP V, A Risk Based Approach to Compliant GMP Computerized Systems ASTM E2500 Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment ISPE Guideline Science and Risk-based Approach for the Delivery of Facilities, Systems, and Equipment, 2011 ISPE Good Practice Guide Applied Risk Management for Commissioning and Qualification, 2011

Nice To Haves

Professional licensure strongly preferred.

Responsibilities

Maintain P+L 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 client’s 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 Client’s using best practices and AI integration
Future – assist in regulatory filings and agency reviews; operational training/staffing for clients