Director, Quality Control - United States
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The position includes the management and oversight of the following activities -analytical, bioanalytical, microbiological and immunological testing; incoming materials testing management; stability programme management; sample management; direct laboratory testing support; method technical transfer and validation; post release testing and regulatory filing support. The compliance and inspection readiness of all Quality Control activities on site and in line with regulatory and quality standards related to the testing Alexion products including release, stability and in-process testing per respective licensed specifications, as well as contract testing services and the technical support of new registrations / filings/ in-country releases. Supporting the pre-commercial testing of Alexion products and material manufactured by the wider network together with the technical support of associated filings. Lead and support QC forums and provide technical expertise in support Alexion QC network. Additionally, the implementation and maintenance of associated QC laboratory systems, advancement of new QC technologies and oversight of new product introduction is included in the overall responsibilities of this role
- Provide leadership and support to the QC laboratory functions in their application of testing standards as well as EHS standards to ensure fully compliant, effective and safe Quality Control laboratories.
- Ensure all QC Standards, Procedures and other GMP documentation are implemented and continuously maintained in a compliant and inspection ready manner.
- Drive the implementation of new QC lab systems and ensure all QC lab systems supporting the QC operation are continuously maintained in a compliant and inspection ready manner.
- Ensure that agreed QC testing lead times are implemented and adhered to for associated in-process, release and stability testing.
- Ensure all QC data required for APRs/complex investigations is supported and provided within agreed timeframes.
- Support the implementation of an effective and efficient laboratory trending programme.
- Ensure standardized QC practices and systems across all QC functional areas and drive the implementation of Operational Excellence best practices and tools.
- Drive the implementation of new QC test technologies.
- Participate in QC forums integral to the development of an Alexion QC network.
- Develop capital and expense budgets for QC Operations, supported by an effective capacity planning tool and continuous KPI monitoring and operate within the approved budgets.
- Represent QC at Board Of Health and regulatory agency inspections
- Oversee the recruitment, retention and development of QC staff. Management of the training and motivation of all QC staff to ensure an agile and flexible workforce.
- Network and liaise as appropriate with other Quality professionals to ensure ongoing knowledge of evolving Quality Laboratory standards.
- To carry out other activities as requested by the ED QC.
- A minimum of 12 years’ experience in a pharmaceutical or biopharmaceutical company in roles with increasing responsibility in quality control laboratory management.
- Extensive GMP laboratory management within a multi-national pharma/biopharma company is essential. Direct regulatory agency interaction also essential.
- Proven ability to build, mentor and grow agile high performing teams
- Knowledge of business and management principles involved in resource allocation, financial management, leadership and co-ordination of people and resources.
- Proven ability to work in a matrixed organization
- Extensive experience of the all regulatory requirements associated with QC method submissions/variations etc, BLA writing and submission.
- BSc/MSc/PhD degree in scientific discipline required.
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.
As a leading employer in our industry, Alexion is proud to offer a highly competitive package of base and incentive compensation as well as a comprehensive benefits program designed to support the health, wellness and financial security of our employees and their families. Benefits include group medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more. To learn more about Alexion, please visit www.alexionpharma.com or download our App for iPhones and Blackberries.
Alexion is an Equal Opportunity /Affirmative action employer