Manager, CQV Portfolio Delivery

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The Portfolio Delivery Manager supports the successful operation of facility, laboratory, and business functions at a multi-use site through interaction with internal team members and customers as well as external service providers. The individual manages multiple projects and ongoing work activities of moderate to high complexity to ensure on time completion. The incumbent’s focus is support of small to medium size validation projects, such as new product introduction, facilities/utilities upgrade and modification, manufacturing and laboratory systems upgrade and modification, including validation delivery and decommissioning/retirement. The incumbent in this role may supervise entry, junior, and experienced level personnel.

Management Responsibilities:

• Supervise small to medium size validation and qualification project teams.
• Develop CQV project scope documents, CQV budget and timelines.
• Assist with interviewing personnel to fill necessary roles.
• Provide direction to internal and external team members.
• Directly supervise contracted project personnel, ensuring that required updates are provided to the functional managers regularly and timely.

CQV Responsibilities

• Understand validation and qualification requirements for different project stages and ensure appropriate validated and qualified state for project release gates.
• Manage vendors responsible for performing validation activities of new facilities, utilities, equipment, and standalone computerized systems and/or changes to existing facilities, utilities, equipment, and standalone computerized systems.
• Liaise with Engineering, Metrology, LSM, and Business Owners, coordinate equipment installation and asset induction.
• Own project change controls and project validation master plans.
• Owns change actions in change controls executed by contracted project personnel.
• Drive validation, qualification, and decommissioning projects to completion, and owns project summary reports.

Technical and Quality Responsibilities

• Understand new technologies, introduced to the Manufacturing and Quality Control areas, and serves as the first line of support during testing and implementation.
• Serves as a technical SME for investigations and deviation resolutions, owns applicable quality actions, as required.
• As a technical SME, owns ECQ equipment FMEAs.
• As a technical SME, assists functional managers as required in documentation review, SOP authoring and revision, and executed data review.

Excellent Customer Service and Support

• Regularly review, prioritize, and promptly respond to business owners’ requests regarding equipment qualification, standalone computer systems validation, and equipment and systems decommissioning / retirement.
• In cooperation with functional managers provide technical support and guidance on equipment and computer systems qualification and validations issues.  Interface with customers to ensure all expectations are being met.
• Maintain a positive relationship with all the members of the Equipment Commissioning and Qualification department and site customers while promoting a positive team environment.

Communication and Management of Timelines

• In cooperation with ECQ functional managers, manage and prioritize staff workload across multiple projects and different departments that the ECQ organiz