• Lead and develop a team of qualification engineers responsible for sustaining commercial activities and/or product development projects with a vision of a quality by design culture and continuous improvements.• Be a change agent in a test-driven culture resulting in industry “gold standard" quality products as reflected by the highest levels of customer satisfaction. • Responsible for meeting quality metrics of commercial and development products• Provide strategic and tactical leadership with a track record of customer focused delivery and shifting a business culture toward quality by design.• Apply knowledge of compliance, risk management, and good engineering practices. • Work with management to identify resource constraints before they happen.• Coordinate training and professional development for the direct reports.• • Facilitate risk and science based decisions during management or quality reviews.• Lead equipment, facilities and utilities performance monitoring and requalification programs
ESSENTIAL DUTIES (REQUIREMENTS)
• Actively represent Qualification Engineering function on commercial value streams and product/core development teams.• Drive good engineering practices within all facets and phases of development and sanction QE metrics across the organization.• Recruit, lead, mentor, and develop a high-performing team of Quality Engineers to implement best practices and continuous improvements.• Collaborate closely with product development and manufacturing to deliver high quality products to our customers.• Advance metrics & goals that provide visibility & understanding of product development and manufacturing effectiveness • Review and approve equipment/process/cleaning validation documentation to ensure compliance.• Implement defect prevention or reduction processes to drive value upstream and supplier projects.• Actively represent Quality Engineering function on commercial value streams, core development teams, and internal/external audits.• Provide guidance to R&D staff and other personnel to ensure Quality by Design (DFSS) tools are implemented appropriately; including those for risk management, reduction of variation, waste, and customer complaints.• Participates in development teams meetings, and technical gate reviews for development or commercial phases.• Draft, review, and approve master validation plans, protocols, and reports for product life cycle and sustaining commercial activities. • Support complaint investigations for root cause and CAPA implementation with statistical and six sigma tools to determine root cause.• Comply with applicable FDA and international regulatory laws/standards.• Maintain and disseminate knowledge of current quality engineering body of knowledge and/or standards as applicable to the development and release of pharmaceutical products.• Responsible for performing design reviews and pre-validation assessments to ensure the safe and sound start-up of new processes. Review the installation, modification and field service of new and existing equipment.• Ensure equipment related information such as trends, issues, availability, performance, and quality (OEE) associated with machine maintenance, calibration and spare parts requirements is properly analyzed and then passed onto the production, maintenance and calibration organizations.
EDUCATION / EXPERIENCE: A minimum of a Bachelor’s degree in Science or Engineering or associated fields is required. A minimum of 3 years of management experience and 10 years in either Quality Engineering, Systems Engineering, Design Assurance, and/or Manufacturing Engineering roles in the Pharmaceutical, Biotech, or Medical Device industry (or related industry), or experience in related engineering areas (e.g. Industrial Eng.). Advanced degrees may compensate for the required experience stated above.
Extensive knowledge of regulatory requirements and engineering tools:
o Risk Management (ICH Q9 or ISO 14971)o Highly proficient in use of applied statistical techniqueso Lean Six Sigma Principles and tools such as: Design of Experiments, Root Cause analysis and/or Problem solving approaches.
o Strong understanding of GxPs: Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), Good Documentation Practices (GDP); Project Management principles; and ICH Q8, Q9, and Q10 procedures.
o Certified Lean Six Sigma Green Belt or Black Belt and/or Certified Quality Engineer (CQE) is strongly desired. Proficiency with Microsoft Word, Excel, Power Point and statistical software (e.g., Minitab) is required. Strong communication skills are required. Experience with organizational and operational excellence principles, delegation, influencing, strategic planning, and execution are desired.
o Ensure the success and development of individuals on the project team by defining clear expectations, providing timely and specific feedback and holding others accountable.
o The ability to work in and communicate well within a team structure in multiple projects, with flexibility to adapt to changing priorities is required. Must be able to work in a fast paced environment, and have excellent communication and emotionally intelligence skills.
o Be highly motivated to develop a team.
o Minimal travel domestically and internationally may be required.