Associate Director, Validation

Position Summary The Associate Director of Validation will lead the Qualification and Validation teams at the site. Serve as a member on project steering, value stream and quality systems performance teams. Establish operational objectives and systems to drive employee engagement and alignment with other departments.

Deliver on site objectives while implementing harmonized engineering systems and processes. Provide leadership support to the other sites and validation initiatives as needed. Will lead system validation projects related to authoring and executing validation documentation for laboratory instruments/equipment and systems according to the ISPE GAMP 5 Validation Life Cycle as well as 21CFR Part11 and FDA’s guide to Computer Software Assurance.

Requirements

, Risk Assessment, IQ, OQ, PQ, Test Scripts, Summary reports,

Traceability Matrix (RTM), Periodic Review of Computer Systems, and Data Integrity Assessment.

for laboratory systems and equipment (Understanding of data integrity principles and security controls including, but not limited to audit trail reviews, user access roles, disaster recovery, business continuity, system implementation, change control, archival, retirement, etc) Strong understanding of Validation Lifecycle (GAMP 5) principles Experience with calibration and maintenance management software Knowledge of electronic document management systems Experience with data integrity practices and compliance Strong technical writing skills for qualification documents, SOPs, and work instructions Ability to manage multiple projects simultaneously with minimal supervision Detail-oriented with excellent verbal and written communication abilities Ability to adapt to changing priorities in a deadline-oriented environment Significant hands-on experience and regulatory expectations knowledge with controls, automation and computer system validation.

Responsibilities

Provide leadership and direction to Validation team members, driving performance and value creation to the site function operational and strategic plans and tasks Ensure adequate resourcing (capacity and capability) to accomplish site and OST objectives. Recommend solutions to alleviate constraints Regularly interacts with senior management or executives on multi-department projects and challenges. Able to build coalitions for change.

) Identify areas to drive down operations costs and improve project delivery efficiency.

Qualifications

Bachelor’s degree.