Quality Director

Requires a minimum of a bachelor’s degree in science, Pharmaceutical Engineering, Engineering, Pharmacy, Biochemistry, Microbiology, Biology, Chemistry or Molecular Biology. Advanced degree in a scientific or engineering discipline is preferred.

10-15 years’ experience in a significant leadership position within the biological and/or pharmaceutical industry and 5 years’ experience in a Quality leadership role required.

Experience & Interaction with FDA/EMEA regulatory requirements applicable to biologics or pharmaceuticals.

Ability to apply GMP regulations and other FDA and international guidelines to all aspects of the position.

Proven success in managing within a global organization.

Strong knowledge in regulatory compliance, Quality Systems, pharmaceutical industry, pharmaceutical methods and procedures and experience with regulatory inspections.

Quality management skills: problem solving, statistical thinking, design of experiments, etc.

Relationship skills: negotiation skills, presentation skills, able to read the corporate culture, listening skills, harvests people’s energy, and manages diverse team members.

Excellent interpersonal skills.

Innovative, tenacious, and passionate about quality.