Keith Brown Email & Phone Number

Shirley, New York, Us

Greenfield, In, Us

Global Quality leadership for the Elanco External Manufacturing organization in North America, LATAM, and Asia Pacific ensuring appropriate oversight of external contract manufacturers and suppliers to assure that all aspects of of the Quality relationship comply with cGMP and regulatory requirements for diverse technologies: Sterile Parenteral, Vaccines, Oral Solid Dose, API, liquid suspensions

Greenfield, In, Us

Paris, France, Fr

Somerset, Nj, Us

Lawrence Township, Nj, Us

Tel-Aviv, Il

Directs the operations of Quality Control and Quality Assurance departments to assure full compliance with federal, state, and local laws and regulations as well as company policies and procedures.

Thousand Oaks, Ca, Us

Quality site lead in charge of GMP and GDP compliance for commercial product distribution, secondary packaging and labeling operations, regulatory compliance, and inspection readiness. I am the primary contact and liaison for all regulatory agency inspections (i.e. FDA, TGA, VAWD, BARDA, CDC). Core responsibilities include ensuring that all products are compliant with SOPs, cGMPs and FDA regulations when released. Author and negotiate quality agreements with GMP service providers and vendors. Overseeing all quality systems, procedures and specifications affecting product quality (e.g., batch records, SOPs, validation protocols and reports) and ensure systems, resources, and action plans are in place attain sustainable compliance. Manage the assessments of complaint investigations. Represent the site on cross-functional teams for establishment of Company-wide quality policies, strategies, and practices.

Indianapolis, Indiana, Us

Managing Global Data Steward for the Global Business Integration Process (GBIP) involving Corporate Good Manufacturing Practice (GMP) applications related to SAP implementation across the company. Ensure trained, aligned staff at appropriate staffing level, Set departmental strategy and objectives, Create annual audit plan for units within area of responsibility, Review and approve audit and assessment reports and summaries, Provide advice on the interpretations of corporate, GMP and regulatory requirements. Maintain efficient communications to relevant groups within the company and with appropriate outside organizations. Review and approve divisional and corporate quality procedures as needed. Human resource development and planning including active resolution of HR issues, creation/review of employees’ performance plans.

Responsibilities included general oversight for the safety, training, and wellbeing of Marines under my area of command as well as the maintenance and availability of $MM motor transport equipment.

Bs/Ba, Biology/Chemistry

Mba, Business