QA Technical Manager

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.

Located at our global headquarters in Emeryville, California, Novartis Diagnostics is constantly finding revolutionary ways to protect the blood supply, and diagnose and monitor patients. Novartis Diagnostics is actively transforming the landscape of disease prevention, diagnosis, and treatment with state-of-the-art nucleic acid testing and advanced molecular science. As part of Novartis Corporation, which has operations in 140 countries and on 5 continents; we provide a truly global environment. This means you will have more opportunities to advance your career and to make a real impact around the world. We invite you to join us!

The QA Technical Manager will serve as a primary representative on projects/programs requiring design control, technical and label review. You will guide and influence new product teams through design and into validation and verification, interface to assure compliance and robust product vs. customer/product requirements. Will ensure compliance with and demonstrate knowledge of site level policies related to design control and change control projects and activities.
Major activities in the role will include:

Define design document requirements for product, process and test methods in accordance with FDA QSRs and specified Design Control Requirements. Relate information to specifications, clinical utility, product claims and design. Provide QA representation for product development and design control teams. Provide QA review and approval of labeling printed materials, e.g., product inserts, user guides, training manuals, operating manuals, etc. Provide QA review and approval of design control related documents, e.g., technical bulletins, customer communications, etc. Apply risk management principles t o assure fitness for use. Implement design control policies and procedures for a program or project. Review and approve Design Control Planning, Device History File(s) and associated supporting documentation. Provide guidance for external software developers. Interact with regulatory and partner auditors / inspectors as needed. Requirements:
3-4 years related technical experience including significant QA experience; medical device software experience preferred. BA/BS in biological, chemical, computer science, engineering or related field and/or other related experience in software engineering desired. Knowledge of quality systems in accordance with cGMP. Knowledge of FDA and EU regulations, and ISO requirements. Skill in the use of computer systems for data compilation, management, and analysis. Experience with leading team or group projects. Project management experience, presentation and meeting organization/facilitation skills desired. Proven ability to express views and opinions clearly, listen well, and accept conflicting points of view. Proven ability as a team player. Excellent analytical and problem solving skills. The person in this position must be able to communicate clearly to a wide variety of people in various disciplines both within and outside the company. Strong interpersonal skills. Excellent scientific, technical, organizational, verbal, and written communication skills.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.