 Responsible for providing strategic leadership, management and direction to the Quality Assurance and Quality Control departments. Develop and manage compliance oversight of clinical and commercial projects and services. Direct and oversee activities to evaluate QA programs and support product release Direct and provide senior level management of the QC Laboratory and its services. Act as primary contact with regulatory agencies and customers for registration, compliance inspections, audits, and quality agreements. Partner with senior leadership to implement inspection and audit readiness activities, and represent company at regulatory inspections. Leader and direct programs for regulatory, internal, customer and third party audits.  Provide leadership and direction for significant events that may impact compliance status and provide recommendations to ensure the highest level of product integrity. Lead implementation of quality monitoring, management reviews, quality risk management and quality improvements. Interact with customers, company management, internal departments, third parties and other sites to provide effective compliance oversight, alignment and guidance. Prepare and effectively manage budgets related to quality and compliance activities.ACCOMPLISHMENTS: Successfully managed simultaneous inspections from FDA and MHRA, addressing each agency’s observations resulting in GMP Certificates from the MHRA. Managed the Quality organization that exhibited a 50% attrition rate. Reorganized the Quality departments, created position descriptions and hired for each role. Reduced the attrition to less than 4% and created a significantly more robust Quality Unit. Created and led the process for management review of quality metrics and reduced the backlog of events by 80% in 6 months. Managed client audits, vendor qualifications, deviations and multiple quality events improving the process and outcome of each.

- Responsible for providing strategic leadership, management and direction to the Quality Assurance and Quality Control (laboratory) departments.- Oversee operations of the Quality Unit related to testing and release of products- Assure regulatory readiness and manage FDA inspections of quality systems- Conduct quality metrics reviews to assure consistent regulatory compliance- Review and approve manufacturing deviations, validation, qualifications and change control documents - Oversee vendor audit and qualification program including contract testing laboratories and raw material manufacturers.- Manage, review, and finalize the completion of inspections and audits to assure compliance with cGMPs, SOPs, company practices and procedures and governmental regulations with department managers.- Oversee, participate and approves the interviewing, hiring and training of department employees; conducts performance evaluations for direct reports.- Ensure project deadlines and performance standards are established and met.ACCOMPLISHMENTS: - Reorganized Quality unit into the QA Compliance and QA Operations, allowing for greater efficiency in responsibilities as well as greater proficiency in job duties.- In collaboration with Site Operations Head, revised the work and shift schedules to become 24/7 operation. This increased production output by more than 18%.- Identified backlog in QC department through an FDA-style mock inspection. Reduced backlog by 80% within 7 months.- Led FDA inspection with zero written observations.- Implemented standardized Quality Agreement with contracted clients- Re-established and led the Management Review Board, identifying metrics to be presented and actions to be taken leading to reduction in lagging quality indicators- Interfaced with the FDA to close one recall and several Field Alerts.- Established a Regulatory Readiness process leading to an efficient execution of the FDA inspection.

• Lead the company’s "FDA Readiness"​ and "Internal Audits"​ programs, establishing new, robust and sustainable programs for each. Lead the Management Notification (for quality events) and Regulatory Notification events. Also a leader in the revision of the Management Notification (of quality events) and Regulatory Notification procedures.• Global Process Owner for the Internal Audit team leading three (3) sites including managing the audit schedule; coaching audit execution; and approving the agenda, reports and auditee responses. • Global Process Owner for the Field Alert/Regulatory Response to Quality Events• Trainer for Regulatory Conduct (conduct expectations during an FDA or other regulatory inspection).• Moderate discussions with Board members in decision-making meetings on field actions.• Act as the liaison for Regulatory Agency communications.• Managed Regulatory Actions including Recalls and other Field Actions.• Provide compliance direction and create metrics for Internal Audit observations and corrective actions including trend analyses.• Maintain the Commitments to Regulatory Agency database; verify timely updates and completion of commitments.• Reviewed and approved critical deviation reports and corrective actions.• Led the Home Office monitoring of simultaneous FDA and MHRA inspections at multiple sites and core team member of the regulatory responses.- Led "FDA simulations" at sites to prepare for inspections.- Highly experienced in Consent Decree remediation having led a section of the work plan to a successful conclusion.

• Direct and manage the Quality Assurance and Compliance Groups (approximately 25 people). • Perform investigations of non-conformances. • Host FDA, DEA and customer audits.• Identify and implement improvements to meet GMP requirements.• Create training program and provide GMP training for production, laboratory, packaging and warehouse personnel. • Initiate Field Alerts and corresponding follow-up investigations and corrective actions. • Perform audits of international sister and parent companies.• Perform external audits of company suppliers and potential vendors.• Write Standard Operating Procedures for Compliance, Manufacturing, QA and Regulatory Affairs• Perform internal audits of all departments requiring compliance with GMPs. • Initiate investigations regarding production or laboratory deviations and recommend corrective actions.• Review, identify deficiencies and approve master batch records and validation protocols.• Direct meetings

- Performed inspections and investigations of biological, food and pharmaceutical establishments with primary duties performing drug inspections. - Position included recognizing and documenting cGMP compliance deficiencies, writing affidavits, documenting violations of the FD&C Act. - Performed inspections that lead to over 12 Warning Letters, 1 Injunction and over 14 Withhold (from approval) Letters.- Certified by the GMP Institute as a GMP Auditor in Quality Systems- Pharmaceutical inspections included systems inspections at domestic and international companies, sterile, non-sterile, solid oral dosage form, veterinary medicine, biotechnology and active pharmaceutical ingredient manufacturers. - Completed all FDA advanced drug training for senior level investigators - Led the most complex inspections and identified as "Lead" investigator on team inspections- Types of inspections included general GMP inspections, Pre-approval inspections and For-Cause inspections. - Received over 14 performance awards including a Letter of Recognition from the FDA Commissioner- Led inspections of pharmaceutical companies in over 22 countries.- Trained junior Investigators on pharmaceutical inspections.Speeches "Preparing For an FDA Inspection" ISPE - CASA (Award of Appreciation 2002 presented; "FDA Initiatives and the Importance of Quality" Amman, Jordan 2006. "The Top 10 Reasons for Quality Breakdown and How to Fix Them"