Senior Manager, CQV

CRB•Raleigh, NC

About The Position

CRB is looking for an energetic, self-motivated individual for the role of Sr. Manager of Commissioning, Qualification and Validation (CQV). The Sr. Manager will support the integration and delivery of CQV services for our Life Sciences clients. Their focus will be to provide guidance on daily operations of the CQV team, including internal and external CQV resources, for all regional projects from proposal stage to facility turnover – this will include leading resources through regulatory requirements, devising and executing strategies, and meeting timelines with risk mitigation. This position requires a high level of organization, communication, leadership, and interpersonal skills that will be used to build strong relationships 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, or Construction Management, or similar degree preferred, or equivalent years of relevant industry experience.
9+ years of Commissioning, Qualification, Validation and Compliance experience in the Life Sciences and/or regulated Industry; Sound technical knowledge of both US and global regulatory requirements. Proficient in cGMP and SUPAC standards.
Demonstrated effective leadership and collaboration skills
Direct experience in managing Commissioning, Qualification and Validation deliverables
Excellent organizational, interpersonal, presentation, and communication skills
Commitment to technical excellence, as well as creating world-class experiences for our clients and employees
Knowledge of US FDA (21 CFR 210, 211, 810) and EU EMEA regulations, ISPE Baseline Guide 5 Commissioning and Qualification and ISPE Guideline Science and Risk-based Approach for the Delivery of Facilities, Systems, and Equipment, 2011
Experience using statistical, risk assessment, and process improvement tools.
Familiarity with validation tools and processes, including environmental mapping and use of Kaye Validator
Ability to plan and execute Smoke / Airflow Visualization Studies
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.
Flexible and willing to travel as needed

Responsibilities

Provide guidance & support for daily operations of the CQV team, including internal and external CQV resources, for all regional projects from proposal stage to facility turnover
Manage and perform the development of validation protocols, the development of validation studies, data analysis, and compilation of the data and results into final reports
Review & Approve User Requirements Specifications (URS), Functional Specifications (FS), Design Specifications (DS), Change controls and equipment, and process Failure Mode and Effects Analysis (FMEA).
As a subject matter expert, represent these activities in discussions and communications with Clients and regulatory agencies
Collaborate in the development of specific CQV plans and ensuring integration with design and construction plans
Responsible for the implementation and execution of the periodic system reviews and requalification activities, as needed
Develop execution schedule and planning efforts on all ONEsolution projects
Interact with regulatory authorities during audits
Mentoring & training employees, both internal and external, on the CQV approach as it relates to each project
Supporting the development of internal qualification documents
Assess impact to validated status of new systems and changes to existing systems using a quality risk-based approach.