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:
PNI specializes in enabling mRNA development including both technology and parenteral formulation development and manufacturing process design and implementation at small, intermediate, and large/commercial scales. This enables the manufacturing of complex lipid-based formulations of therapeutic agents for preclinical and clinical testing as well as transfer of drug product manufacturing to both internal and external commercial facilities. We are currently in the process of developing the first Canadian mRNA Covid vaccine and building a state-of-the-art clinical/manufacturing facility. The Head of Quality is critical to helping PNI move from an R&D environment to a state-of-the-art GMP manufacturing operation, this role is as much about cultural transformation as it is about technical improvement and business growth, specifically building, leading, and engaging the entire PNI team along its quality evolution.
The Head of Quality is responsible for developing and executing a quality assurance vision for PNI that incorporates best in class quality assurance standards, testing approaches, as well as purchasing strategies and frameworks. Unique to this role is the diversity of implementing one quality system to support: mRNA development and manufacturing, nanoparticle technology and lipid supply for both research and commercial applications. Overseeing that all relevant safety, operational, and quality system procedures and standards are implemented, monitored, and continuously improved, the Head of Quality will be responsible for ensuring PNI is well-positioned to meet all business, safety, customer and process requirements.
Areas of Responsibility:
Establish departmental goals and effectively communicate direction, objectives, and results as needed to the department, plant site, staff. Develop and actively manage team conformance to departmental budget and drive improved efficiencies in departmental operations. Develop, implement and continuously improve the quality system procedures that are effective and compliant to applicable standards. Establish cGMP training systems and perform on -site staff training. Ensure PNI meets business and customer requirements with respect to the development and transfer of testing methods for raw materials, in-process controls, and intermediate and final products. Complete new client questionnaires as required by the sales teams to support the development of new customer projects and products. Coordinate and host customer audits and develop audit responses as required by the respective auditing customer. Coordinate and host regulatory agency audits, coordinate follow-up communication and supervise necessary corrective actions on site. Ensure compliance with all commitments (to customers or authorities) in conjunction with regulatory approvals of products and processes. Establish and manage QA tracking and trending of essential performance measures and the preparation of periodic reports for management review. Chair the Management Review meetings.
Qualifications and Experience:
M.S. or Ph.D. degree in chemical or biological sciences, pharmaceutical technology, chemical engineering, or equivalent experience. 15 years of experience in GMP manufacturing, Quality Assurance / Quality Control or similar operational areas in pharmaceutical or medical device industry, with at least 5 years in a leading position. Experienced with hosting foreign and domestic regulatory inspections (US-FDS, EU Authorities). In depth knowledge of regulatory requirements, i.e. GMP, Health Canada, EU, and FDA and experience with GMP documentation review. Experienced in hosting customer audits and certification audits (e.g. ISO 9001, ISO 13485). Strong interpersonal skills with the ability to influence others across multiple functions. Exhibits initiative to recognize and solve problems. Ability to apply compliance standards to daily production situation.
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.
PNI is an equal opportunity Employer