Director, Operational Readiness CQV

Overview

Lead operational readiness for life science projects, managing CQV, turnover, and startup.

Key Responsibilities

• operational readiness
• turnover planning
• data management
• regulatory review
• digital innovation
• stakeholder management

Tasks

-Lead the development of specific Turnover, Operation, and CQV plans to ensure integration with design, automation and construction plans -Lead and Support the Operational Readiness approach internally and externally with client’s Design, Operations, Quality, and Regulatory teams -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 -Active management of internal and/or external Operational Readiness resources on projects -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 -Work with Construction and Digital Innovation to deliver streamlined data management across various platforms -Manage regulatory reviews, be part of operational design reviews, develop overall risk-based approach for testing/documentation -Manage our partners and/or build a group to execute the integrated delivery strategy -Future – assist in regulatory filings and agency reviews; operational training/staffing for clients

Requirements

• bachelor's degree
• 15+ years
• regulatory
• iso 9001
• leadership
• csv

What You Bring

-Excellent organizational, interpersonal, presentation, and communication skills. -Knowledge of primary industry guidance on CQV and CSV, including but not limited to: -ISPE Good Practice Guide Applied Risk Management for Commissioning and Qualification, 2011 -ASTM E2500 Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment -Direct experience in producing and managing commissioning, qualification, and operational deliverables. -ISPE Baseline Guide 5 Commissioning and Qualification, edition 2 -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. -ISPE Guideline Science and Risk-based Approach for the Delivery of Facilities, Systems, and Equipment, 2011 -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. -Familiarity with all phases of design and construction required; direct experience in Life Sciences capital projects preferred. -Knowledge of US FDA (21 CFR 210, 211, 810), ISO 9001, and EU EMEA regulations -Professional licensure strongly preferred. -ISPE GAMP V, A Risk Based Approach to Compliant GMP Computerized Systems

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Benefits

-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.

About Crb

-Global design-build and consulting firm with international offices. -Integrating engineering, architecture, construction, and consulting. -Projects include biopharma facilities, processing plants, and research campuses. -Unified ONEsolution model streamlines design and construction delivery. -From a basement start to delivering high-tech labs and large-scale breweries globally.

Sector Specialisms

Security Clearance

-employment is contingent on background screening.