Director of Quality Assurance
QUALIFICATIONS
- Bachelor’s degree in a science / technical field such as Pharmacy, Biology, Chemistry, or Engineering or any bachelor’s degree with three years of experience in pharmaceutical industry in roles covered by GMP oversight.
- Excellent oral and written communications skills.
- Strong ability and motivation to learn.
- Minimum of five years of experience in the pharmaceutical industry and / or FDA experience with at least a minimum of three years of experience in Quality Assurance / Compliance.
- Preferred minimum of seven years of experience in QA / Regulatory Compliance in the p pharmaceutical industry.
- Strong knowledge of global regulatory and cGMP requirements, industry best-practices.
- Strong familiarity with production operations.
- Strong leadership, project management, and technical writing.
- Strong interpersonal, communication, and influencing skills.
WORK ENVIRONMENT
Office environment with business casual dress. May require business attire.'
Benefits :
We’re proud to offer a comprehensive benefits package, including :
Medical Insurance – PPO & HMO plansDental and Vision CoverageFlexible Spending Account (FSA)Life Insurance OptionsShort-Term and Long-Term Disability (STD / LTD)401(k) Retirement Plan2) Quality Engineer
Qualification
Education and / or Experience
Bachelor’s degree in Engineering, Manufacturing, Mathematics or Business. In lieu of a degree, relevant years of work experience may suffice.0-3 years’ experience working within quality engineering systems.Experience working with, or knowledge of, business management systems particularly ISO 13485 preferred, and FDA Title 21 Part 820, QSR.ASQ Quality Engineer Certified within one (1) year as requested.Experience in or knowledge of SPC and Statistical Analysis.Computer skills in MS-Office and Data Analysis Software to calculate statistics (such as Excel, Mini-Tab, etc.).Self-Motivated analytical data driven decision maker with strong leadership skills.Strong commitment to quality and customer service.Demonstrated problem solving skills requiredLeadership Ability