Director, Operational Readiness CQV

Description

• Coordinate/collaborate with Regional leadership in business development and account management on Market Focus, Trends, and developing New Client Solutions
• Work with Construction and Digital Innovation to deliver streamlined data management across various platforms
• Active management of internal and/or external Operational Readiness resources on projects
• Maintain P+L responsibilities for business team and accountable to achieve Regional Team Revenue and Profit goals
• Manage our partners and/or build a group to execute the integrated delivery strategy
• Collaborate/Support the Digital Innovation team in the delivery of project data to Client’s using best practices and AI integration
• Develop and maintain relationships with ley stakeholders for successful projection execution
• Manage regulatory reviews, be part of operational design reviews, develop overall risk-based approach for testing/documentation
• Lead and Support the Operational Readiness approach internally and externally with client’s Design, Operations, Quality, and Regulatory teams
• Lead the development of specific Turnover, Operation, and CQV plans to ensure integration with design, automation and construction plans
• Future – assist in regulatory filings and agency reviews; operational training/staffing for clients

Requirements

• Knowledge of US FDA (21 CFR 210, 211, 810), ISO 9001, and EU EMEA regulations
• 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.
• Excellent organizational, interpersonal, presentation, and communication skills.
• ISPE GAMP V, A Risk Based Approach to Compliant GMP Computerized Systems
• ISPE Good Practice Guide Applied Risk Management for Commissioning and Qualification, 2011
• Professional licensure strongly preferred.
• 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
• Knowledge of primary industry guidance on CQV and CSV, including but not limited to:
• ASTM E2500 Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment
• Demonstrated effective leadership, financial management and collaboration skills.
• ISPE Baseline Guide 5 Commissioning and Qualification, edition 2
• Familiarity with all phases of design and construction required; direct experience in Life Sciences capital projects preferred.
• Bachelor’s Degree in Architecture, Engineering, Life Sciences, Construction Management, or similar degree preferred, or equivalent years of relevant industry experience.
• Direct experience in producing and managing commissioning, qualification, and operational deliverables.

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.

Training + Development

Interview process

Visa Sponsorship

Security clearance