Responsible for the creation and management of key Quality Assurance Systems, related to the manufacturing, testing and release of Pharmaceuticals, Medical Devices & Biologics at Fort Worth, TX manufacturing and contract manufacturing organizations.

Provides strategic leadership to the compliance team and able to formulate a compelling vision for future state of the team and establishes metrics to monitor, improve and sustain performance. A people leader who is able to motivate and drive the team to sustain a high performing culture.Develops and maintains quality assurance programs, policies, processes, procedures and controls ensuring that performance and quality of products conform to establish standards and agency guidelines to ensure lasting customer satisfaction. Provides expertise and guidance in interpreting governmental regulations, agency guidelines and internal policies to assure compliance to current requirements and expectations. Serves as liaison between the company and the governmental agencies and notified body. Works directly with operating entities to ensure that inspections, statistical process control analyses and audits are conducted on a continuing basis as specified to enforce requirements and meet specifications. Establishes and ensures compliance with good housekeeping practices, employee hygiene and equipment sanitation; analyzes plant error, salvage, spoilage reports and process statistics for significant findings and conclusions; establishes policy and strategy during new product start-ups, change control execution for plant processes and systems and key checkpoints for new products and processes.

I manage overall Quality and Compliance activities during the product development life cycle processes and to ensure related practices adhere to market(s) Health Authority regulatory requirements as well as the Novartis Corporate GMP Quality Manuals. In addition, to ensure R&D activities are in compliance with regulations.• Manage and lead the Quality / Compliance activities for all assigned new product launches• Manage and lead Quality / Compliance initiatives to improve NCH Quality Systems.• Act as liaison between R&D and Product Supply and provide assistance in project transfer to commercial QA/QC.• Author and implement local and global SOPs.• Review and approve CMC and non CMC related documents, including product specification, batch documentation, test method, analytical validation report, method transfer, equipment qualification and calibration related documents, process validation protocol and reports and packaging documentation.• Support clinical supplies activities, including providing formal approval and release for clinical supplies and registration samples.• Manage Change Control, Planned / Unplanned Deviation and CAPAs• Perform due diligence audits and provide QA / Compliance expertise for business development initiatives as required. • Perform cGMP audit of internal R&D facilities an operations as well as 3rd Party vendors• Manage Heath Authorities audits including communicating audit findings, issues audit reports, evaluate and follow up on the appropriateness and completeness of corrective action plans until closure. • Provide QA / Compliance support for manufacturing and packaging activities at 3rd party operations.• Prepare Quality Agreement new products to be launched.

Quality Assurance/Quality Engineering for GMP manufacturing. •Manages and leads Quality/Compliance activities for commercial and developmental drug products (ANDA/NDA). Ensures appropriate Quality System GMP Documentation for Chemistry, Manufacturing & Controls (CMC) applied at each stage. •Performs technical reviews and quality approvals of change control, unplanned deviations, CAPAs, and other Quality System Documentation

• Established and implemented departmental policies to improve efficiency and ensure compliance with the requirements of Novartis Quality Modules, GMP requirements, FDA guidance documents and other regulatory requirements.• Authored and executed GMP manufacturing and packaging equipment validation documentation including Installation, Operational, Commissioning, and Site/Factory Acceptance Test protocols and reports. • Developed Standard Operating Procedures (SOP) and user worksheets to streamline equipment qualification process for common equipment subgroups. • Developed User Requirements for electronic document system/Computer System Validation and acted as third party liaison for contracted computer validation.