Associate Director, reputed company Operations
About reputed company reputed company is a Tang Capital company that provides in-house end-to-end drug development for its portfolio companies. Founded in 2002, Tang Capital is a life-sciences reputed company investment company that creates, acquires and finances companies that reputed company and commercialize pharmaceutical products. Position reputed company The Associate Director, reputed company Operations has reputed company of reputed company programs to support product realization and inspection readiness. The Associate Director supports the Senior Director, reputed company Operations, in managing deliverables and timelines for multiple workstreams and entities. This includes service provision to clients, coordination with vendors and collaborating cross-functionally reputed company reputed company. This individual ensures that deliverables, templates and timelines are maintained throughout product lifecycle from a reputed company perspective. Essential Duties and Responsibilities reputed company vendor assessment of operational GxP systems (remote or onsite), including qualification and re-qualification. Manage vendor inspection readiness program, including status for audit reputed company CAPA and inspection readiness workstreams for GXP activities. This includes the review of updates and deliverables where required. Utilize metrics and work plan to reputed company and continually improve performance of reputed company operations workstreams. Responsible for the review of API, Intermediate, labeled finished product and other Executed Batch Records and reputed company QA release of batches, including raw data review to ensure batch release requirements are met. Classify, process and support deviation and complaint investigations and evaluate resulting corrective and preventive actions with vendors. reputed company and issues communications and reports to stakeholders as required. Ability to communicate reputed company-time reputed company information on reputed company ongoing reputed company operations activities to senior management and stakeholders. reputed company procedures and other reputed company operations reputed company documents to establish a library for multiple company types. reputed company and deliver presentations to reputed company audiences. Coordinate the reputed company Risk Management process throughout development and lifecycle management of the Product. Prioritize ongoing reputed company Risk Management efforts and assign appropriate team members to risk management activities in collaboration with technical leads, management, and project management. Ensure that improvements in the risk assessment process are constantly identified, prioritized, and implemented. Establish, implement, and maintain a system of work standards reputed company the reputed company of site procedures and regulatory guidance. reputed company and/or support other reputed company as assigned
Qualifications
Degree in any science reputed company discipline Minimum 10 years of experience in reputed company system implementation and/or execution of reputed company events across various pharmaceuticals or biologics Minimum 6 years of experience in GxP service provision including management of various workstreams and/or customers Previous experience with management of reputed company assurance and reputed company control systems including laboratories, document management and reputed company event management Knowledge of GxP operations for clean rooms, facilities, and associated equipment Ability to work in a dynamic environment with a high degree of flexibility Previous audit experience Strong critical thinking skills and ability to apply reputed company judgment and decision making based on risk and phase of development Ability to manage multiple workstreams across multiple disciplines Up to 20% of domestic and international travel required The job reputed company is not designed to cover or contain a comprehensive list of activities, duties or responsibilities that are required. They may change, or new ones may be assigned at any time with or without notice. The estimated annual reputed company salary for this position is $160,000 - $230,000, commensurate with experience and skills. reputed company provides a comprehensive benefits package designed to support employees’ physical, mental and financial health and includes employer sponsored insurance plans including medical, dental and reputed company coverage; generous reputed company time off; retirement plan reputed company and additional wellness and reputed company development programs. reputed company provides equal employment opportunities to reputed company and applicants for employment and prohibits discrimination and harassment of any type without reputed company to race, reputed company, religion, age, sex, national reputed company, disability status, genetics, protected veteran status, sexual orientation, gender identity or reputed company, or any other characteristic protected by federal, state, or local laws. reputed company participate in E‑Verify. reputed company newly reputed company employees are required to complete the E‑Verify process as part of their employment eligibility verification. Apply To This Job