Manager – CQV Portfolio Delivery

Manager – CQV Portfolio Delivery

Requirements

• Knowledge of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, computer systems validation requirements and good documentation practices.
• Advanced knowledge of pharmaceutical, manufacturing and laboratory systems and equipment that support cell therapy clinical manufacturing.
• Ability to develop, delegate and motivate others including direct and indirect reports.
• Understanding of project scheduling and execution principles.
• Strong written and verbal communication skills.
• Excellent interpersonal skills with experience dealing with a diverse workforce.
• Strong multi‐tasking ability in conjunction with proven organizational skills. Ability to organize assigned tasks in a high paced environment and concurrently monitor tasks / assignments with others that may impact timely completion. Ability to effectively manage multiple tasks and activities simultaneously.
• Highly proficient in Microsoft Office Suite – Word, Excel, PowerPoint, and Outlook. Innate ability to learn new software, such as corporate intranet and enterprise business.
• Working knowledge of scheduling software and systems, and inventory management systems.

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.
• 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.
• 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.
• 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.
• In cooperation with ECQ functional managers, manage and prioritize staff workload across multiple projects and different departments that the ECQ organization serves.
• Maintain ECQ project schedules, and report ECQ timelines and task completion at project meetings.
• Continually seek opportunities to increase internal client satisfaction and deepen client relationships.

Preferred Qualifications

• BS in Engineering or Science related discipline.
• Minimum of 5 years of experience in FDA-regulated industry (validation preferred), or 3 years and an advanced degree. A combination of relevant experience, education, and training is acceptable.
• Minimum of 3 years of experience managing personnel and/ or projects.
• Strong instrumentation background and experience in laboratory and manufacturing operations.
• Knowledge of cGMP in the pharmaceutical industry.
• Excellent computer skills including knowledge of asset management and project management software.
• Strong problem-solving skills, strong verbal and written communication skills, and the ability to work independently.
• Experience interacting with regulatory agents, external and/or internal auditors in a compliance audit environment with direct interaction including face to face interaction and response to audit questions.