Providing quality assurance oversight to all aspects of validation, calibration, and maintenance of equipment, utilities, and facility infrastructure for GMP Cell Banking, Drug Substance, Drug Product, and Analytical Research Laboratories.Ensure the validated state, calibration and maintenance of equipment, utilities and facilities supporting manufacturing and laboratories aligns with procedures, corporate policies and regulatory requirements.Review and approve change controls including assessment of impact to validation and supporting operations and laboratories maintaining a validated state.Review related validation documentation such as specifications, protocols, testing documents, summary reports, data integrity assessments and validation plans.Review and approve equipment and facility calibration documentation as needed.Review and approve role-related investigations, commitments and procedures.

Providing quality assurance oversight to all aspects of validation, calibration, and maintenance of equipment, utilities, and facility infrastructure for GMP Cell Banking, Drug Substance, Drug Product, and Analytical Research Laboratories.Ensure the validated state, calibration and maintenance of equipment, utilities and facilities supporting manufacturing and laboratories aligns with procedures, corporate policies and regulatory requirements.Review and approve change controls including assessment of impact to validation and supporting operations and laboratories maintaining a validated state.Review related validation documentation such as specifications, protocols, testing documents, summary reports, data integrity assessments and validation plans.Review and approve equipment and facility calibration documentation as needed.Review and approve role-related investigations, commitments and procedures.

Auditing Equipment, Facility, and Computerized Systems qualifications to ensure they are complete, accurate, and subsequent changes have been properly documented.Determining final acceptance and release of all GMP Equipment, Facility, and Computerized Systems changes.Ensuring compliance with FDA 21 CFR Part 11, Part 210, and Part 211 Requirements, Internal Quality Requirements, and other Health Authority Agency expectations for Equipment, Facility, and Computerized Systems. Ensuring that all Equipment, Facility, and Computerized Systems related to manufacturing and laboratory testing is classified as GMP status is qualified, fit for intended use, and maintained in a validated state.Implementing Qualification, Change Management, Calibration, and Maintenance program improvements. Updating Standard Operating Procedures to reflect improvements.Lead New Product Introduction product containment initiative with 94 new products that limit the spread of highly potent substances for manufacture and packaging of OSD drug products.Participate in cross functional meetings for planning and discussing changes to commissioned, qualified, validated equipment, facilities, utilities, and computerized systems. Provide QA oversight for discrepancies/deviations related to manufacturing equipment, laboratory instruments, facilities, utilities, and computerized systems.Provide QA oversight of commissioning, qualification, and validation activities for 5,000+ manufacturing and laboratory equipment. Performing change control assessments and reviewing/approving change control implementation plans for equipment, facility, utilities, and computerized systems.Quality Review and Approval of design and commissioning documentation, validation protocols, reports and support records, as well as functional testing documents for Equipment, Facility, and Computerized Systems. Ensures timely resolution of documentation, compliance, and quality system issues.

Managing rollout and metrics of new quality culture and simplification/streamlining initiative for Head of Quality; compliance strengthening resulting in over 100+ Quality initiatives.Linking 6 Quality Systems inspection model to responsible functional groups, site procedures and FDA commitments.Performed audit support roles for all levels of Quality Department.Managing site Quality phase-out metrics.

Auditing Equipment, Facility, and Computerized Systems qualifications to ensure they are complete, accurate, and subsequent changes have been properly documented.Determining final acceptance and release of all GMP Equipment, Facility, and Computerized Systems changes.Ensuring compliance with FDA 21 CFR Requirements and other Health Authority Agency expectations for Equipment, Facility, and Computerized Systems from a quality perspective.Ensuring that all Equipment, Facility, and Computerized Systems related to manufacturing and laboratory testing is classified as GMP status is qualified, fit for intended use, and maintained in a validated state.Evaluating and implementing product containment measures that limit the spread of highly potent substances for manufacture and packaging of OSD drug products.Implementing Qualification, Change Management, Calibration, and Maintenance program improvements. Updating Standard Operating Procedures to reflect improvements.Providing Final Quality Review and Approval of Computerized System Validation deliverables for the validation process. Providing Final Quality Review and Approval of pre-execution and post-execution Installation, Operational, and Performance Qualification protocols as well as functional testing documents for Equipment, Facility, and Computerized Systems.Providing Quality oversight to Equipment, Facility, and Computerized Systems projects related to manufacturing and laboratory testing of pharmaceutical OSD product by ensuring that any and all changes impacting the GMP state of Equipment, Facility, and Computerized Systems are executed under Change Management.

Assist the Cleaning Validation team in authoring cleaning documentation and risk assessments for GMP manufacturing rooms and equipment.Assist the Quality Investigation team with retrieval of documentation.Manage continuous workflows for high priority manufacturing and quality documentation. Work with manufacturing operators and upper management on refining continuous manufacturing improvement.