Senior Director Of Quality Assurance - Remote Opportunity!!

Description

ApiJect is seeking a Sr. Director of Quality Assurance. The Sr. Director of Quality Assurance will report to the VP of Project Management and Quality. The Sr. Director will be responsible for providing leadership and compliance oversight of quality activities associated with medical devices and combination product development and manufacturing processes internally or at contract manufacturing organizations (CMOs).

• Design control oversight including review and approval of design development documentation for all phases of development from feasibility, planning, design, Verification, Validation and Design Transfer stages including risk management files and change controls.
• Oversee the quality process from Research & Development Design through commercialization.
• Accountable as Quality Key Point of Contact for Medical Device driving excellence specific GxP processes and procedures partnering with internal or external stakeholders as applicable.
• Provide strategic direction and leadership in developing innovative initiatives to improve overall quality outcomes.
• Develop strategic quality and process improvement initiatives that establish a culture of quality.
• Defines areas of responsibility, personnel requirements, and operational procedures within the QAU.
• Supporting cross functional activity to ensure audit readiness is in place for all aspects of the product lifecycle.
• Leads all client or regulatory agency audits; responsible for formal responses to their findings/recommendations.
• Lead the development and maintenance of quality systems programs, policies, processes, procedures, and controls ensuring that performance and quality of the Quality Management System complies with regulation, standards, and agency guidelines.
• Research and incorporate best practices into the organization.
• Reviewing and approving CAPA (deviations & actions); includes performing risk assessments, participating in root cause analysis investigations, effectiveness checks.

Position Requirements

• Support CMO selection, maintenance and overall management from a quality perspective
• Pharmaceutical experience required
• Experience in blow fill seal products or sterile injections
• Proven ability to work in a fast-paced environment and meet tight timelines
• Bachelor’s Degree in scientific discipline (e.g. Mathematics, Engineering, Biology, or related field)
• Internal and external auditing experience from clients and regulatory agencies
• Ability to collaborate cross-functionally to meet business objectives without compromising regulatory compliance
• 12+ years of experience (dependent on education) in Quality/Regulatory preferably with combination products
• Subject matter expert in applicable standards such as CFR and ISO
• Experience in the compilation and maintenance of design history files (DHF)
• Demonstrated ability to lead a Quality Assurance Unit (QAU) in order to ensure regulatory compliance

About the Organization ApiJect Systems, Corp.™ is a medical technology company creating the future of pharmaceutical injections. ApiJect products are designed to provide the advantages of prefilled syringes (quality, convenience, safety) at the cost-efficiency of multi-dose formats, regardless of manufacturing volume.

Our Platform achieves this by bringing together two globally trusted manufacturing technologies: Blow-Fill-Seal (BFS) aseptic filling and high precision injection molding. This approach can be seen in our first prototype device that is in development, a single-dose prefilled injector, designed to expand current commercial markets and also help improve global health access so more healthcare workers can give patients the medicines and vaccines they need

We are a small, fast-growing company with a remote workforce located primarily in the United States, but also with colleagues, offices, and/or close manufacturing partners in Europe and Asia.

EOE Statement We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status or any other characteristic protected by law.