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AboutCodera

Codera 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 focused investment company that creates,acquiresand finances companies that develop and commercialize pharmaceutical products.

Position Summary

The Associate Director, Quality Operations has oversight of quality programs to support product realization and inspection readiness. The Associate Director supports the Senior Director, Quality Operations, in managing deliverables and timelines for multiple workstreams and entities. This includes service provision to clients, coordination with vendors and collaborating cross-functionally within the company. This individual ensures that deliverables, templates and timelines are maintained throughout product lifecycle from a quality perspective.

Essential Duties and Responsibilities

• Perform vendor assessment of operational GxP systems (remote or onsite), including qualification and re-qualification.
• Manage vendor inspection readiness program, including status for audit related CAPA and inspection readiness workstreams for GXP activities. This includes the review of updates and deliverables where required.
• Utilize metrics and work plan to track and continually improve performance of quality operations workstreams.
• Responsible for the review of API, Intermediate, labeled finished product and other Executed Batch Records and perform 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.
• Develop and issues communications and reports to stakeholders as required.
• Ability to communicate real-time quality information on all ongoing quality operations activities to senior management and stakeholders.
• Develop procedures and other quality operations related documents to establish a library for multiple company types.
• Develop and deliver presentations to internal and external audiences.
• Coordinate the Quality Risk Management process throughout development and lifecycle management of the Product.
• Prioritize ongoing Quality 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 within the framework of site procedures and regulatory guidance.
• Lead and/or support other projects as assigned
  

Qualifications

• Degree in any science related discipline
• Minimum 10 years of experience in quality system implementation and/or execution of quality 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 quality assurance and quality control systems including laboratories, document management and quality 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 sound 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 description 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 base salary for this position is$160,000 - $230,000,commensuratewith experience and skills.

Coderaprovidesa comprehensive benefits package designed to supportemployees physical,mentaland financialhealthandincludesemployer sponsoredinsurance plansincludingmedical, dental and vision coverage;generous paid time off; retirement plan options andadditionalwellnessandprofessional developmentprograms.

Codera provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.

Codera participate in EVerify. All newly hired employeesare required tocomplete the EVerify process as part of their employment eligibility verification.