Responsible for Global Quality and Regulatory Affairs Pharmaceutical and Medical Device

Most responsible person for Quality at Reata. Directed quality operations, including quality assurance, quality control, quality systems, clinical quality, pharmacovigilance, and quality oversight of all GXP systems. Led strenuous preparation cycle to ensure readiness for all upcoming FDA inspections.• Completed five clinical trial site inspections, one sponsor BIMO inspection, and two manufacturing site PAIs with no observations. • Corrected all issues from clinical and manufacturing quality side in six months.• Prepared 14 clinical trial sites and five manufacturing sites and passed all pertinent inspections without any issues.• Prepared EU and Japan for all required inspections. Passed PMDA inspection with zero observations.

The most responsible Quality person for AMAG Pharmaceuticals and Cord Bank Registry (CBR). Managed quality organization for AMAG Pharmaceuticals and Cord Bank Registry (CBR). Led all quality (quality assurance and quality control), clinical quality assurance, and pharmacovigilance. Administered CMC module 3 of all submissions. Provided oversight for six major clinical trials in the USA and EU.• Navigated company through three pre-approval inspections, two bioresearch monitoring inspections, and one pharmacovigilance inspection with zero observations.• Helped transition two NDA products to commercial distribution through six successful FDA inspections of AMAG facilities with zero observations.• Served as NDA submissions and FDA liaison for two recent NDA approvals

Most responsible Quality person for the Drug products division of AMRI. Led drug products division of AMRI, including 12 aseptic fill drug production plants located in US, Europe, India, and China. Administered quality assurance function (MFG QA support) and quality control functions (microbiology labs, analytical chemistry labs). Contributed to bioavailability studies in order to determine correct formulation of drug products. Provided customer support in developing formulation of ANDA products as well as extensive regulatory support for regulatory submissions.• Achieved three successful product approval inspections (PAI) and one baseline general GMP inspection through extensive training and remediation activities.• Established effective Quality Enterprise System that helped manage deviations, CAPA, complaints, and supplier quality.• Built top-performing quality teams that consistently succeeded with FDA and global regulatory agencies.• Performed due diligence and acquisition activities in order to provide inorganic growth for company. • Participated in three successful acquisitions and integrations, including $450M acquisition.

Directed quality, regulatory, and compliance for Getinge. Led eight direct reports. Managed quality for six plants in Europe, one plant in China, one plant in Brazil, and five plants in the US. Administered all regulatory affairs for Class II and Class III medical devices, including 510(k) (12) and PMA (3) submissions to US FDA and all design dossiers used for submissions worldwide.• Completed significant FDA remediation effort of four manufacturing plants while remaining in full production. • Improved quality system and reduced customer complaints by 40%. Improved manufacturing yields by 15% overall. • Negotiated a very advantageous consent decree that allowed Getinge to keep the majority of products in the market.• Oversaw clinical quality assurance, including eight concurrent trials (five trials in EU and three trials in USA).• Two PMA and 12 510(k) submissions approved.

Managed eight direct reports with 475 total staff. Served as quality member of Novartis Americas leadership team, with responsibility for North and South America and Latin America, including eight manufacturing sites, country organizations, and third-party supply organization. Managed quality and regulatory compliance for Americas region manufacturing plants as well as quality for 78 third-party manufacturers. Operated as region’s principal FDA and health authority liaison.• Set up third-party quality organization in order to transfer core products from closed Lincoln, Nebraska plant ($1.4B in sales from plant) to third-party manufacturer while maintaining ability to withstand strenuous FDA and WW regulatory scrutiny. • Completed extensive remediation of Humacao, Puerto Rico and Lincoln, Nebraska manufacturing plants; transformed plants from the brink of receiving warning letter to passing difficult FDA inspections and approval recommendation for Sentinal product (NDA).• Established quality systems in country organizations, including detailed metrics system geared to run the business on data. Enabled leadership team to be fully informed of product performance in the field.• Implemented new Americas quality system that yielded zero recalls.• Spearheaded team that created NDA for pharma-to-OTC switch of Voltaren. • Led preparation and served as primary liaison (FDA) for Voltaren Pharmaceutical to OTC switch Pre-Approval Inspection (PAI). Achieved zero FDA observations and secured recommendation for product approval.

Served as member of Novartis leadership team and chairperson of Novartis Drug Device Group. Managed worldwide quality and regulatory compliance. Set up IVD medical drug/device quality system from scratch. Participated in lead team for Genoptix acquisition; oversaw quality at all sites, including Cambridge, San Diego, and Basel. Conducted joint clinical trials with different pharmaceutical global product teams and commercialized the drug with in-vitro diagnostic. Led group responsible for monitoring clinical trials and compliance with clinical trial protocol. Administered Genoptix CLIA Laboratory in Carlsbad, California.

Managed WW quality regulatory and clinical affairs for strong growth division of GE. Directed 3,000-patient clinical trial in the area of digital pathology and computer-aided diagnosis. Led design controls process for development of new digital pathology platform. Negotiated regulatory and clinical strategies with FDA and notified bodies. Served as member of Executive Steering Committee. Filed for three de novo 510 applications of digital automated pathology instrumentation and six 510(k)s for computer-aided diagnostics applications

Most responsible Quality Regulatory Professional in the company. Managed global quality and regulatory affairs for all collagen-derived implantable products. Led creation and submittal of pre-market approval applications, investigational device exemptions, and 510(k) applications. Remediated Quality System in order to meet FDA and ISO 13485 standards. Served as QA/RA lead for eight FDA inspections with zero 483 observations. Received approval for three pre-market approval applications and 18 510(k) applications. Expedited product approval for sale by coordinating and anticipating requirements for FDA submissions.

Supervised eight directors, five regulatory associates, and 325 employees worldwide. Implemented Six Sigma methodologies as well as standardized regulatory submissions and quality systems for diabetes care business. Established baseline for detailed site audits and achieved zero FDA observations.

Established process validation system and clinical affairs group while overseeing six directors, four managers, and 300 personnel facilitating global operations. Utilized Six Sigma methodologies in creation of quality standards regulatory compliance production and compliant design controls, software QA, process control, and documentation control systems. Spearheaded development of compliant and Corrective Action Preventative Action (CAPA) system with worldwide validation.

Led WW Quality and Regulatory compliance for the Cardiology, Neurology, and Endovascular businesses. Company designed and manufactured Minimally invasive medical devices for the treatment of cardiovascular, neurovascular and endovascular areas. Sales in excess of 3 billion.

Managed Miami Quality R &D and Manufacturing site. Primary liaison for over 100 FDA and ISO inspections. All inspections considered the site in substantial compliance.

Led Quality Assurance (QA) Quality Control (QC) as well as Compliance for the Product manufacturing sites. Established close relationship with manufacturing, Tech Ops as well as R&D. Great success with FDA inspections.

Submarine Service, USNUSS George C Marshal SSBN 654