Director, Quality

At Miltenyi Biotec, 3,000 employees worldwide develop pioneering solutions for biomedical science and the clinical application of cell therapies. Our multidisciplinary team combines excellence in research with the development of innovative products for the treatment of serious diseases.

Your Tasks

As a leader of the Quality Team, you will apply your proven expertise to ensure that all aspects of the Quality management system are effectively established, implemented and maintained in accordance with FDA regulations. Furthermore, you be responsible for the organizational GMP compliance for relevant operations carried out within and for the site and its clients, including activities related to related to preclinical and clinical supply of investigational cell therapy products. Finally, your responsibilities will include overseeing the Quality group to ensure high quality standards are maintained and will set expectations on project team performance, which will drive the continuing business success of Miltenyi as a whole.

Requirements

• M.S. or B.S. in a life sciences or engineering discipline and a minimum of 10 years’ experience in Quality Assurance, Quality Control, Compliance or related fields in biopharmaceutical products and at least 8 years management experience; or equivalent combination of education and experience
• In depth knowledge of the regulatory environment (FDA, ICH) for the manufacture of medical products, specifically aseptically filled biological products and substantial GMP experience is required

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to walk; use hands to finger, handle, or feel; reach with hands and arms, talk, and hear. The employee is required to stand; climb or balance and stoop, kneel, crouch.  The employee must occasionally lift and/or move up to 20 pounds. Specific vision abilities required by this job include close vision, color vision, peripheral vision, depth perception and ability to adjust focus.  Must have ability to handle more than one task at a time and must work at a rapid pace while maintaining attention to detail. 

Work Environment

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. This job is performed in a temperature controlled facility without exposure to extreme hot or cold temperatures. Generally, this job is performed in a clean laboratory setting and routinely uses standard medical and research equipment such as centrifuges, biosafety cabinets, microscopes, incubators, chromatography devices and columns, tangential-flow filtration devices and filters, peristaltic pumps and metering fill pumps, pipettes and computers. While performing the duties of this job, the employee is frequently exposed to blood, viruses, bacteria, body fluids and other tissues. Employees entering and leaving the laboratory must wear appropriate clothing and protective equipment such as lab coats, glasses and gloves. The noise level in the work environment is usually moderate. Due to the travel requirements, this position may be exposed to natural elements of nature.

Miltenyi Biotec is expanding and evolving. Our culture is one that empowers you to embrace new challenges and influence change. Join a fresh and collaborative working environment that encourages contribution, innovation, and growth.

We empower great science. For over 30 years, Miltenyi Biotec has provided innovative tools, instruments, and solutions that advance biomedical research and cellular therapy. We are 3,000 scientists, engineers, physicians, support specialists, marketers and more – all dedicated to improving scientific understanding and impacting human lives. At our headquarters campus and offices worldwide, fresh ideas become unique products.

Miltenyi Biotec, Inc. is an EO Employer – M/F/Veteran/Disability/Sexual Orientation/Gender Identity