Responsible for developing and managing new consulting projects from the pharmaceutical, biotechnology, and medical device industry. This individual will serves as QA interface to clients, so excellent interpersonal skills, strong communication skills, strong documentation skills and organizational skills are essential requirements. In addition, this person will be accountable for meeting project goals and objectives as they relate to meeting contractual obligations for cGMP and ISO standards in a timely manner.
DUTIES AND RESPONSIBILITIES:
Initiate and maintain channels of communications with potential and current clients, and develop new market opportunities with them.
Assist in identifying resource needs for each project and hire new employees, as need arise.
Follow-up on the progress of projects and ensure implementation of appropriate problem resolutions and verify effectiveness.
Evaluate customer requests for information (e.g., state of compliance to potential customer specifications) and prepare formal responses.
Carries out technical and administrative duties as assigned.
EXPERIENCE AND QUALIFICATIONS:
A minimum of a B.S. degree with at least 5-7 years of relevant experience in pharmaceutical, medical devices, life science, Biodefense or any other similar industry.
KNOWLEDGE, SKILLS AND ABILITIES:
Experience in interpreting and working knowledge of FDA’s Quality System requirements and ISO standards.
Experience utilizing statistical techniques within a manufacturing environment is a plus, but not a requirement.
Extremely detail-oriented, self-starter and ability to manage multiple priorities simultaneously, proactive task management capabilities.
Ability to solve moderate to complex problems and complete multiple projects to meet challenging timelines with attention to detail.
Strong linguistic, grammar, and editing skills a plus.
Proficiency with Microsoft applications Word, Excel, Project, and PowerPoint.
This is a work from home full-time position with travels to client locations from time to time. So, self-disciplined approach, commitment, and daily reporting of work progress is absolutely necessary for this job.