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The Senior Vice President, Operations leads Manufacturing, Quality Assurance, Pharmacovigilance, Regulatory Affairs, and related Business Development strategy for the Company. Manages a diverse team to plan and implement drug manufacturing (including vendor management and coordination across multiple third-party contract manufacturers) and Operations strategies and tactics to meet commercial manufacturing needs for the organization. Ensures an efficient, on-time and on-budget, quality driven organization is in place to meet regulatory agency requirements and operational needs. Creates an internal environment of quality and compliance while establishing a sense of urgency to meet timelines and program milestones.
Primary executive responsible for defining and managing the company’s operations strategy and business development assessments, commercial manufacturing management and supply chain coordination through multiple third-party suppliers, and strategic planning for back-up suppliers.
Responsible for cross-functional project management for a range of programs, due diligence activities and assessment, acquisition integration teams, and representation with key external partners.
The Director of QA is responsible for the development, implementation, and management of Assertio's internal and external quality strategy, and Quality Assurance (QA) systems to achieve compliance with company standards, cGMP, FDA regulations and guidance. The Director will oversee and approve quality standards related to the manufacturing, testing, and release of commercial drug products and clinical trial supplies. The Director is also responsible for interacting successfully with Executive Management, other department heads, external suppliers and service providers to ensure manufacturing compliance and release of API, commercial drug products, and clinical supplies. The Director is the primary interface with FDA and other regulatory agencies on quality issues and during inspections.
Responsible for assisting with subsidiary maintenance and other corporate secretarial matters, compliance oversight and reporting, monitoring of related party transactions, Section 16, proxy and other SEC reporting and disclosure, corporate governance, contract review and approval, and assisting the legal department on other matters that may arise. In addition, the individual in this role will work closely with multiple attorneys, other members of the Legal Department and business clients providing legal support for a wide array of corporate transactions.