R&D Documentation & Compliance Manager

Biosite is the leading provider of rapid medical diagnostics that improve the quality of patient care and simplify the practice of diagnosing critical diseases and health conditions. Our existing product portfolio and product roadmap respond to the challenges faced by hospitals and physician offices by providing cost-effective diagnostic information rapidly - in minutes versus hours, which helps save lives. Biosite?s current products include rapid point-of-care diagnostics in cardiovascular medicine, specifically congestive heart failure and myocardial infarction. Biosite manufactures and markets one of the most widely used toxicology panels, which assesses overdose of a broad spectrum of common prescriptions and illicit drugs. Founded in 1988 as a venture-backed start-up, Biosite has become a biotech success story. The company went public in 1997 with 120 people and has grown to 1,000+ employees worldwide. Our revenues have also continued to grow and are expected to exceed $300M in 2006.

Position Description:

Join Biosite's Research & Development department as a ?Documentation & Compliance Manager?. With a brand new, state-of-the-art 350,000 square foot biotechnology facility in the Sorrento Mesa area of San Diego, Biosite has functionally designed its new facility to inspire innovation, operational optimization, work-hard/play-hard philosophy, and cross-departmental communication and collaboration. As a key team player in the R&D department, directly reporting to the V.P. of R&D, you will be responsible for the following activities:

Coordinating and maintaining R&D?s documentation and compliance program in accordance with Design Control requirements. The scope includes Marker Discovery, Sample Bank, Chemistry, Product Development, Product Support, Software and Meter Development and Database Management.

Coordinating the review and revision of procedures, specifications and forms.

Providing input and work with R&D, QA, and Program Management personnel to ensure compliant processes for research, development, product support and the R&D portion of product transfer activities.

Authoring and overseeing approval of documents, SOPs and reports.

Developing budget and expenditures and making recommendations to senior management for resources required to support the activities of the R&D documentation and compliance program.

To Apply Visit Biosite

Qualifications:

Preferred educational background:

BS or MS in Chemistry, Biochemistry, Biophysics, Bioengineering or related field.


Preferred experiential background:

Minimum of 10 years of technical, QA and/or regulatory experience in the biomedical, diagnostic or pharmaceutical industry with subjstantial experience and knowledge in the following areas:

-Product research and development
-Design Control
-Quality System (audit and/or regulatory experience is highly desirable)
-Data Analysis and interpretation (good knowledge of biostatistics is desired)
-Technical writing and presentations
-Supervisory experience

-Minimum 5 years Experience with FDA and ISO regulations.
-Detail oriented and well organized.
-Demonstrated skills in carrying out assignments with minimal guidance in an accurate, effective manner.
-Able to supervise and work with a variety of people on multiple tasks.
-Excellent written and verbal communications: ability to reduce complex technical data and ideas to simple, clear and auditable reports and documents.
-Ability to manage and organize a large and complex workload involving the coordination of activities and input from multiple people, including senior staff in other departments.