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CRB · 6 days ago

Director, Operational Readiness CQV

Boston, MA

Full-time

Onsite

Director/Executive

15+ years exp

CRB is a leading provider of sustainable engineering, architecture, construction and consulting solutions to the global life sciences and food and beverage industries. The Director of Operational Readiness will lead cross-functional teams to integrate and deliver Operational Readiness services on capital projects, focusing on achieving a faster production timeline for clients while ensuring compliance with regulatory requirements.

BiotechnologyConstructionConsultingWeb Design

H1B Sponsor Likely

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

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

Qualification

CommissioningQualificationValidationComplianceLife Sciences experienceRegulatory knowledgeLeadership skillsFinancial managementTechnical excellenceInterpersonal skillsOrganizational skillsPresentation skillsCommunication skillsCollaboration skills

Required

Bachelor's Degree in Architecture, Engineering, Life Sciences, Construction Management, or similar degree preferred, or equivalent years of relevant industry experience

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

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

Benefits

Complete and competitive benefit package designed to meet individual and family needs

Company

CRB

Glassdoor3.6

CRB is a leading provider of sustainable engineering, architecture, construction and consulting solutions to the global life sciences and food & beverage industries.

Founded in 1984

Basel, Basel-Stadt, CHE

1001-5000 employees

https://www.crbgroup.com/

H1B Sponsorship

CRB has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2021 (2)