Executive Director, Global Quality Systems & Standards - United States
- The Executive Director, Global Quality Standards and Systems (GQSS) has overall responsibility for developing and delivering an enterprise world class Global Quality Standards and System program that keeps pace with evolving business and regulatory requirements and expectations.
- This role will be responsible for setting the Global Quality Standards and Systems strategy, developing or amending the Global Quality System, directing resources, and ensuring execution of the program and related activities.
- The Executive Director, GQSS will be responsible for driving and maintaining the company’s Quality Policy and Manual across the enterprise.
- The Executive Director, GQSS will be accountable for ensuring excellence in the development of Quality Standards and Systems, harmonization and standardization and will ensure that all standards and systems comply with applicable regulatory requirements, guidelines, laws, and Company's established standards and practices.
- The Executive Director, GQSS is a member of the Global Quality Leadership team and works in close partnership with the Divisional Quality Leads across the enterprise.
- Leads GQSS group; direct supervision of GQSS employees, including recruiting, objective setting, performance management, coaching, training and developm
- Provides strategic vision and expertise for establishing and managing company's Global Quality Standards and Systems.
- Develops and drives strategy and process for managing and maintaining compliance with company’s QMS across company sites, global affiliates and vendors.
- Ensures that Corporate Procedures and Standards are properly deployed into company’s QMS and are managed accordingly.
- Identifies and implements enabling technology solutions (e.g. training and learning management systems, document management system)
- Develops and implements of Global Quality System standards, policies, guidance and SOPs.
- Drives a Quality culture and related programs (e.g. Quality objectives)
- Works collaboratively within company’s network to ensure that the Quality Standards and Systems are effectively implemented at all global sites
- Establishes metrics for monitoring the implementation and effectiveness of the Quality Systems
- Drives continuous improvement activities
- Generates reports, analysis and recommendations regarding Quality Systems performance
- Represents the company as a subject matter expert during regulatory audits for Global Quality Standards and Systems issues, as necessar
- Travel of up to 30% may be required.
- 10 to 20 years of hands-on experience working in the area of Quality Standards and Systems in the pharmaceutical/ biotech industry.
- Thorough knowledge of applicable global regulatory and GxP requirements required.
- Bachelor’s degree is required. An advanced degree is preferred. Must have minimum 8 years’ experience progressive people management experience.
- Our company is a global biopharmaceutical company focused on developing and delivering life-transforming therapies for patients with devastating and rare disorders. Our company developed and commercializes the first and only approved complement inhibitor to treat patients with paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS), two life-threatening ultra-rare disorders.
- As the global leader in complement inhibition, our company is strengthening and broadening its portfolio of complement inhibitors, including evaluating potential indications for eculizumab in additional severe and ultra-rare disorders.
- Our company's metabolic franchise includes two highly innovative enzyme replacement therapies for patients with life-threatening and ultra-rare disorders
- In addition, our company is advancing the most robust rare disease pipeline in the biotech industry, with highly innovative product candidates in multiple therapeutic areas