A TOP consulting firm is looking for a full-time Data Integrity Director to join their team. This company works with some of the top pharmaceutical companies world-wide. This permanent position will oversee Data Integrity teams throughout the country. Don't miss out on this amazing, remote opportunity.
- Leads multiple, highly complex projects through their project life cycle.
- Project Management: manages and delivers large, complex client engagements and implement business solutions.
- Oversees the production of consulting service deliverables for clients.
- Directly interacts with client and/or a client organization to navigate projects successfully to completion.
- Performs quality control, technical writing, and management of projects.
- Manages client engagements, including oversight of consulting time to bring projects to completion on time and within budget.
- Managing client engagements, assigning, and managing consultants and ensuring the timely completion of high-quality deliverables as related to quality and compliance activities.
- Maintains comprehensive knowledge about the pharmaceutical industry including the ability to understand and interpret current/envisioned regulatory and compliance processes and procedures.
- Familiar with all major manufacturing processes for both small and large molecules, aseptic environments, and controls.
- Extensive knowledge in Pharmaceuticals and Supply Chain.
- Knowledge of FDA regulations and requirements in a GxP setting.
- Knowledge of 21 CFR Part 11 for Data Integrity.
- Strong Technical and Analytical Skills
- IT experience -validating computerized systems for GxP / pharma. ERP, Manufacturing, Laboratory, Quality Assurance.
- Performed quality and data audits for Laboratories and Manufacturing setting.
- Ability to travel
- S in Chemical Engineering, Industrial Engineer, or Pharmaceuticals
- 15 years of experience; 5 years in GxP pharma manufacturing environment; 5 years working with pharmaceutical compliance regulations focused on data integrity and