•Oversee performance of QA shop floor activities. Supervise Field Quality Assurance employees. •Ensure manufacturing compliance with applicable procedures and batch records. •Perform real time review of manufacturing batch records. •Review manufacturing shop floor documentation. •Critically review investigations, interpret results and generate technical conclusions consistent with quality risk management principles. •Skilled in planning and organizing, decision-making, and building relationships. •Knowledge of quality processes, including material disposition, change control, product complaints, deviations, investigations, and CAPA management.

•Providing senior level support for issues of moderate complexity at a minimum. •Routine management & coordination of GMP compliance systems and policies for cGMP compliant facilities. •Review and approval of Quality Systems which include deviations and CAPA as well as supporting disposition as appropriate. •Collaborates with multiple departments to ensure appropriate RCA and CAPAs have been identified. •Monitors policies, processes, procedures and controls ensuring that performance and quality of products conform to established standards and agency guidelines to ensure lasting customer satisfaction. •Demonstrate high level of involvement in continuous improvement of quality assurance philosophy and practices to ensure the highest standards are maintained. •Examines programs to create efficiencies in practices and optimal utilization of staff. •Review of production records for compliance. •Assures cGMP’s and company procedures are followed and, if needed, procedures/policies are revised. •Accountable for meeting functional area goals and objectives as they relate to departmental and company-wide goals. •Responsible for adhering to GMP regulations, cGMP’s, company policies, and leadership capabilities.• Oversaw staff development, including job safety, cross-training, new/revised standard operating procedures, and refresher GMPs/FDA training.• Built and implemented strategic plans for organizations and programs ensuring staff and systems continued to meet emerging business needs.

•Issue, review, and approve Change Controls (CCs) related to all controlled documents.• Supervised staff in multiple functions including raw materials, fill, packaging, and distribution.• Audited hundreds of raw material suppliers and internal functional areas against domestic and international regulations, quality agreements, industry standards, and guidelines• Conducted area tours representing functional areas during regulatory inspections by FDA, EMA, and other regulatory agencies, partners and internal auditors.• Provided QA review and approval of standard operating procedures, authorization for destruction records, and clinical and commercial raw materials specifications• Reviewed and dispositioned batches of raw materials, drug substance, drug product, and finished goods ensuring compliance with internal procedures and regulatory requirements•Performs GMP walkthrough inspections to ensure compliance with cGMPs and regulatory requirements.•Actively participates in site inspections/audits by facilitating discussions with inspectors/auditors, fulfilling requests for information and presenting to inspectors on required topics as Quality representative. Supports the preparation of regulatory filings.•Responsible for the review and release of intermediate or final bulk material for downstream formulation/filling for both domestic and international markets.•Prepares and submits release protocols to CBER. Prepares CoAs to support regulatory filings.

• Supervised staff in multiple functions including raw materials, fill, packaging, and distribution.• Conducted area tours representing functional areas during regulatory inspections by FDA, EMA, and other regulatory agencies, partners and internal auditors.• Planned and supervised the daily activities of the quality assurance operation and inspectors, to ensure work is completed in a timely and accurate manner.• Train, coach, and mentor QA personnel. Ensure training records are complete and accurate.• Be proficient in all areas of manufacturing and packaging inspection process, including in-process QA, line inspection, label cage operation, incoming inspection, and expiration date assignment.• Perform these duties as needed and directed by QA Management.• Review batch records for accuracy and completeness for product disposition. Ensure that corrections are made in a timely manner.• Possess a working knowledge of statistical based sampling plans and their application.• Conduct evaluations and compliance audits of manufacturing and warehouse personnel and areas to ensure procedures are being followed in accordance with GMP compliance.• Conduct real time batch record reviews in assigned areas.• Create, review, and revise SOPs and assist with ER investigations as applicable.• Perform data analysis, identify corrective/preventive actions, and implement process improvements with a focus on quality processes.•Provide input and decision making for quality on the shop floor with regard to manufacturing and deviations. Provide corrective actions as necessary.•Monitor assigned area for compliance to SOPs and cGMPs – equipment, documentation, and personnel.

• Provided management review and approval of deviations, complaints, change controls, qualification/validation documents and system reports.• Write, edit, review, approve and implement site Standard Operation Procedures (SOPs).•Manages departmental costs to assure compliance with the approved budget and in conjunction with the Director identifies/justifies the need for variances from the budget.•Attends or facilitates meetings in support of initiatives. Provided coverage in the absence of Director.•Personnel development of supervisors and analysts, setting goals and objectives for supervisors and direct reports.• Monitor assigned area for compliance to SOPs, change control, and risk analysis, – equipment, documentation, and personnel..• Perform data analysis, identify corrective/preventive actions, and implement process improvements with a focus on quality processes.• Prepared program management correspondence spreadsheets, charts and presentations. Conducted research and prepared management, organizational and business analyses and forecasts. • Provides oversight of facilities ensuring compliance with standards with regard to control of facilities, personnel, processes and materials.