We have an immediate need for a Director of Quality for between 15 and 25 hours per week. Reporting to Executive Management, this position will focus on Wolfe Laboratories operations and be responsible for the company quality compliance program. Candidates should have significant current expertise in the regulatory world of pharmaceutical companies and/or CRO’s including an in-depth understanding of regulatory requirements in the drug development process.
POSITION DUTIES AND RESPONSIBILITIES:
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
REQUIRED BACKGROUND AND EXPERIENCE:
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
ADDITIONAL DESIRABLE EXPERIENCE:
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
IMPORTANT PERSONAL CHARACTERISTICS:
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
Interested candidates are requested to email a copy of their resume with a cover letter including salary history to:rick.eastwick@wolfelabs.com.
Wolfe Laboratories, Inc. (WLI), located in Watertown, MA, is a contract research and development organization that provides services to the pharmaceutical and biotechnology industries. We partner with drug discovery organizations to solve scientific challenges and accelerate the growth of IP. Our services are focused on the transition of small molecule and protein therapeutics from discovery research to early clinical development. These services include analytical/bioanalytical method development, qualification and validation, in vitro DMPK, preformulation, formulation development and optimization, process development and optimization, stability testing, finished product testing, and product complaint testing. We have extensive experience in preformulation and develop liquid, lyophilized, dispersed systems, solids, and semi-solid dosage formulations. We work closely with prospective clients to build the appropriate scope and design of projects, and assist in technology transfer to manufacturing facilities.
We have had a steady 10-year track record of growth, success and profitability.
