FierceBiotech and FiercePharma Jobs
DIRECTOR OF QUALITY - Global Allied Pharmaceuticals
Jan 12
Location: Various Locations, Categories: Pharmaceutical
Website: http://www.gapsos.com
Position Description
Will consolidate, manage, and extend our current quality program to ensure GxP compliance. Will contribute as a hands-on Director in an individual contributor role. Will distill from the imprecise language of government regulations the essence of those often complicated and imprecise rules and lead the company to an understanding of how to choose the right quality approach that will satisfy regulators as well as Wolfe business objectives. Will provide the necessary training to Wolfe employees. Will conduct quality audits, both in-process and data audits. Will coordinate and participate in inspections by client companies and regulatory authorities insuring that Wolfe is properly prepared and that the inspections are well managed and successful. Bachelor’s degree in Chemistry, Biochemistry, or related field Seven (7) years of experience in a Quality role in a pharmaceutical company, CRO, or similar business Three (3) years of experience in a GxP environment Two (2) years of experience in a leadership or managerial role in the quality field Demonstrated ability to manage multiple quality programs and deliver on time results Considerable current expertise in the regulatory world of pharmaceutical companies and CRO’s including in-depth understanding of regulatory requirements in the drug development process Is able to properly interpret the regulatory landscape for Wolfe and defend the choices. Experience hosting regulatory inspections as well as doing audits In-depth knowledge of GxP requirements Experience in a training role Excellent communications skills including written, oral, presentation and listening skills Highly organized with strong project management skills Proficiency in Microsoft Word, Outlook, Excel, and PowerPoint. Advanced degree in Chemistry, Biochemistry, or related field Ten (10) plus years of experience in a Quality role in a pharmaceutical company, CRO, or similar business Five (5) plus years of experience in a GxP environment Five (5) plus years of experience in a leadership or managerial role in the quality field Experience in both large pharmaceutical and small or start-up companies Experience as a consultant in a consulting practice focused on quality programs in pharmaceutical companies Demonstrated experience as a quality champion Demonstrated ability and willingness to be hands-on in the multiple aspects of a successful quality program. Possesses excellent attention to detail as well as a big picture understanding and appreciation Demonstrated ability to work well under pressure and commit to aggressive timelines A passion for playing the multiple roles of scientist, guide, trainer, mediator, business person, administrator, and salesperson Demonstrated ability as a flexible and effective consensus builder
