Director of Quality Assurance

About Precision NanoSystems Inc. (PNI)

Precision NanoSystems Inc. (“PNI”) is a manufacturer of instruments, kits and reagents in the global nanomedicine market providing tools for drug development and cell-specific delivery to study, diagnose and treat disease. PNI’s NanoAssemblr family of instruments allow scientists to rapidly develop novel nanomedicine drug candidates for pre-clinical testing. PNI’s NanoAssemblr Scale-up platform enables the translation of these drug candidates to clinical testing and eventually to commercial use. PNI’s NanoAssemblr™ Transfection Reagents use nanomedicine technology to deliver genetic materials in primary cells vitro and in vivo, enabling disease researchers to easily study gene function in high-value models of disease. PNI sells its products to leading pharmaceutical and biotechnology companies, and leading academic institutions in over 20 countries worldwide.  Please find more information at http://www.precisionnanosystems.com/.

Position Summary 

The Director of Quality Assurance is responsible for supporting the development and implementation of GMP systems at PNI, with responsibility for oversight of all internal GMP activities and supporting internal research functions as needed. The individual will manage the evolving the quality documentation system, provide compliance oversight to applicable internal activities, maintain internal documentation processing functions and organizational records management. The individual is expected to identify gaps in the current quality, propose viable solutions, and lead the process for improvement.

Areas of Responsibility

• Develops, implements, and coordinates an organizational wide quality of service strategy and related programs through support staff and lower echelon managers.
• Evaluates and enhances current quality of service programs to improve employee relations, customer retention and overall organizational culture.
• Provides leadership and training to lower echelon managers on implementing quality of service strategies within functional teams.
• Leads meetings with quality of service team members to communicate necessary information, receive updates and answer inquiries.
• Cooperates with other top management personnel to formulate quality of service initiatives and strategies in accordance with overall organizational goals.
• Analyzes, evaluates, and presents customer and employee feedback regarding quality of service to stakeholders and other organization leaders.
• Adjusts quality of service programs and strategies according to feedback from employees and customers.
• Serves as the organization’s subject matter expert on quality of service initiatives and procedures.
• Intakes concerns and violations of organizational quality policies.
• Works with managers and supervisors to administer constructive feedback and disciplinary action.

Qualifications and Experience 

• Undergraduate education in basic or applied science (chemistry, biological sciences, pharmacology, pharmaceutical science). Master’s degree preferred.
• 3-4 years’ experience in a pharmaceutical, biotech or medical device environment required.
• A practical working knowledge of computers, computer software applications and data management is necessary.
• A solid understanding of applicable regulations and guidelines as well as experience with GMP’s in a working manufacturing environment are required.
• A working knowledge of GMP requirements for Clinical Trial Material in both the US and EU including sterile manufacturing is strongly preferred.
• Certified Quality Auditor (CQA) would be a plus.

PNI provides a competitive compensation and benefits package with excellent opportunities for personal growth.

Only candidates selected for an interview will be contacted. Posting valid until filled. No solicitors please.

Precision NanoSystems, Inc. is an equal opportunity employer.