Senior Director, Quality - United States
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The Senior Director, Head of Quality (Alexion Rhode Island Manufacturing Facility) is responsible for providing professional support to the ARIMF site on all quality, cGMP and compliance subjects, and is a decisional base for all quality matters while taking into account local regulations and requirements.
Responsibilities include bulk drug substance manufacturing oversight and final lot disposition for commercial and clinical use. Responsible for QA oversight and compliance of commissioning, qualification and validation activities during the expansion phase of the ARIMF facility. Responsible for reporting on all Quality activities at the site to the Plant Manager. Management of Quality Systems implementation and management of (change control, CAPA and deviations); audit support; plant QA operations; internal product technology transfer; and facility compliance.
Sets strategy to enhance and maintain Quality oversight at the ARIMF facility including:
- Ensures that there is an empowered, effective and efficient quality organization in place at ARIMF and that the site is staffed with competent personnel having the appropriate degree of experience and expertise.
- Build and sustain employee engagement by creating a culture of efficient execution and an environment in which individuals and teams can excel and continuously improve.
- Maximize the utilization of quality resources to insure compliant, cost-effective, and on-time supply of products.
- Ensure robust measurement and reporting tools are developed to enable accurate and timely reporting to senior management
- Protects the company against regulatory action by ensuring compliance with regulations in all relevant markets.
- Strategic oversight and leadership to meet functional and site goals and objectives.
- Responsible for QA oversight and compliance of site commissioning, qualification and validation activities of the expansion of the ARIMF facility.
- Execution of product disposition (drug substance).
- Responsible for maintenance and development of the Quality system and accountable for quality oversight of quality management systems (CAPAs, Change Controls, Deviations).
- Champion site metrics to ensure targets are achieved, met and countermeasures in place when applicable.
- Assuring appropriate GMP and QA systems training of QA personnel and customers.
- Responsible for site specific QMR management and gathering of APQR data.
- Preparing for/ supporting/ leading regulatory inspections and third party audits.
- Responsible for continuous improvement on an ongoing basis to proactively mitigate current and future risks to maintain an effective operation to support business needs.
- Retain and develop first class staff responsible for the management of quality operations to ensure the compliance of Alexion commercial and clinical products.
- A minimum of 15 years’ experience in a pharmaceutical or biopharmaceutical company in roles with increasing responsibility in quality management.
- Proven ability to build, mentor and grow high performance site based teams.
- Knowledge of business and management principles involved in resource allocation, financial management, leadership and co-ordination of people and resources.
- Extensive experience of first hand GMP management within a multi-national pharma/biopharma company is essential, and will include exposure to FDA / EMA / ANVISA or other authorities of similar standing. Success in multicultural management and the resolution of technical challenges require significant appropriate experience.
- Experience in providing Quality oversight for engineering and validation projects supporting internal operations and tech transfer activities.
- Experience leading, training and/or implementing root cause analysis and effective investigation practices.
- Strong operations background to ensure value added and effective quality operations. Experience driving out inefficiencies and improving turnaround times.
- Undergraduate degree in scientific discipline, pharmacy or engineering required.
- Advanced degree (MS, PhD, MBA) desired.
Smithfield, RI, United States
Alexion is a global biopharmaceutical company focused on developing and delivering life-transforming therapies for patients with devastating and rare disorders. Alexion developed and commercializes Soliris® (eculizumab), 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, Alexion is strengthening and broadening its portfolio of complement inhibitors, including evaluating potential indications for eculizumab in additional severe and ultra-rare disorders. Alexion’s metabolic franchise includes two highly innovative enzyme replacement therapies for patients with life-threatening and ultra-rare disorders, Strensiq® (asfotase alfa) to treat patients with hypophosphatasia (HPP) and Kanuma™ (sebelipase alfa) to treat patients with lysosomal acid lipase deficiency (LAL-D). In addition, Alexion is advancing the most robust rare disease pipeline in the biotech industry, with highly innovative product candidates in multiple therapeutic areas.