Mgr, Quality Control (Analytical / Raw Materials)

Novartis is a world leader in offering medicines to protect health, cure disease and improve well-being. Our goal is to discover, develop and successfully market innovative products to treat patients, ease suffering and to enhance the quality of life. We also seek to provide a return to shareholders that reflects our performance and to adequately reward those who invest ideas and resources in our company.

Summary:
Phase A (Start-up Phase): Provide the technical knowledge and support for technology transfer from the QC labs in Marburg, Germany to QC Holly Springs, USA. Ensure that the lab and equipment qualification, assay validation, and start- up of the according labs meet cGMP requirements and the requirements of the Novartis V&D Quality Manual and stay within the defined schedule. Phase B (Operational Phase): Make sure that the Novartis Vaccines and Diagnostics cell culture based US flu vaccine is tested according to quality requirements defined via registered specifications and are released to market in accordance with local/international regulations. Align the testing with time and cost requirements.

Major Accountabilities
Start-up Phase: · Support that the all aspects of the design, qualification and start-up of the new corresponding labs comply with the requirements of the Novartis V&D Quality Manual and meet all relevant cGMP regulatory requirements. · Support the transfer of the necessary analytical methods, documents and systems from Marburg, Germany to Holly Springs, US by field work in Marburg, Germany. · Define user requirement specifications, support determining and auditing suppliers as well as external contract laboratories for raw material testing. · Support warehouse set-up with regard to raw material management and sampling. · Responsible that all laboratory equipment is appropriately selected, qualified/validated and that all analytical methods transferred from Marburg, Germany to Holly Springs, US used are validated. · Establish professional and qualified lab teams, direct the teambuilding. · Support a timely and successful pre-approval inspection of the corresponding QC labs at the new site. · Strong knowledge of HPLC method validation requirements. Strong working knowledge of UV-Vis, IR, and wet chemistry skill and method validation. Strong knowledge of Lab Quality Systems.

Operational Phase: · Ensure that samples of every description (working seed virus; virus harvest; cell controls; monovalent and trivalent bulk antigen ?drug substance?, final product ?drug product?, and in-process materials) are tested in accordance with the registered specifications and lo-cal/international regulations in order that product release will occur according to the produc-tion and sales plan. · Ensure that all raw materials, primary packaging materials (e.g. drug product containers and closures) and labelling will be released in time. · Coordinate, control and follow-up on raw material sampling and raw material testing in-house and with external contract laboratories. · Coordinate day-to-day quality control related activities in the field of responsibility with other departments (e.g. with Quality Assurance, Quality Compliance and Production). · Ensure operation at highest possible lab and personnel usage rates at minimum costs and with minimum failures. · Ensure preparation, update and implementation of standard operating procedures, qualifica-tion and validation documents for the relevant equipment and assays. · In cooperation with Engineering ensure that labs and equipment are maintained properly. · Ensure thorough analysis of failures (e.g. in testing) and implement corrective and preventive measures in cooperation with Quality Assurance and Quality Compliance. · Responsible to decide on critical subjects such as product rejections. · Identify and ensure implementation of improvements in the field of responsibility correspond-ing to the standard of knowledge, cooperation with the corresponding departments. · Ensure compliance with quality standards according to cGMP as defined by respective SOPs and guidelines. · Ensure alignment with QO strategy. · Ensure compliance with Health Environment and Safety regulations in cooperation with other departments. · Provide technical advice for generation of submission documents. · Bear responsibility for staff and costs. Ensure that the labs operate in a cost effective and effi-cient manner and maintain an innovative approach based on productivity improvement, im-plementation of best practice and harmonisation within Technical Operations. · Ensure appropriate training of staff. Ensure that they are qualified, achieve a high level of com-petence, and ensure that they are motivated and carry out their duties in a safe manner. · Support personnel and facility/industrial hygiene monitoring. · Responsible for the realization of safety, security, hygiene and ecology regulations in the corre-sponding labs.

Education / Experience: A bachelors degree in a scientific displine with 8+ years experience in a Quality Control and/or in a GMP regulated environment within the biopharmaceutical industry such as Manufacturing required. A minimum of 5+ years experience in a supervisory / management role within Quality required. Chemistry background with experience in analytical / raw material testing required. Advanced degree preferred.Novartis Vaccines & Diagnotics is a new division of Novartis consisting of two businesses focusing on the development of preventive treatments and tools. Novartis Vaccines is the world's fifth largest vaccines manufacturer and second-largest of flu vaccines in the United States an equal opportunity employer.