Full Job Description
Principal Quality Engineer - ECM
Job Description
SUMMARY OF POSITION:
This position is for a Principal Quality Engineer to work enterprise-wide to develop and deploy quality standards and tools for External Contract Manufacturing. In addition, this position provides support in quality and technical matters to Regional teams and contract manufacturers.
ESSENTIAL ACCOUNTABILITIES:
- Contributes to the development and implementation Quality initiatives to ensure that external manufacturers produce safe, clean and effective products.
- Deploys initiatives and measures in the areas of:
- ECM Quality System Requirements
- ECM Governance process
- Oversight of ECM performance (scorecards).
- Coordinates ECM initiatives with multi-regional and multi-functional teams.
- Collaborates with R&E, ECMS and other Quality functions for the effective deployment of a Quality System throughout the different stages of the product lifecycle: Design Controls/Product Development, Technology Transfer, Commercial Manufacturing, Post-Market Surveillance and Discontinuation.
- Provides support and build capability for Regional teams and ECMs in the areas of:
- Facility Controls /Sanitary Manufacturing
- Process Validation
- Good Manufacturing Practices such as: Hygiene Practices, Environmental Controls, Stability Testing, etc. Provides technical expertise and support in root cause analysis and complex problem-solve during investigations of deviations and nonconformities (Critical Swat Team)
- Provides technical expertise and support in root cause analysis and complex problem-solve during investigations of deviations and nonconformities (Critical Swat Team)
- Maintains comprehensive knowledge of applicable regulatory requirements and industry standards.
- Leads the development of strategic performance metrics and reports as required.
GENERAL EXPECTATIONS AND ACCOUNTABILITIES
- Manage self in accordance with the expected One K-C Behaviors.
- Influence and recommend new quality concepts, tools and initiatives for External Contract Manufacturing
- Builds capability in self by maintaining and demonstrating a high degree of knowledge and skill in quality management systems, processes and regulations.
- Builds and maintains strong relationships and networks with key stakeholders and peers within the business unit, across the enterprise, and across industry.
- Establishes and maintains collaborative relationships while driving solutions to meet business needs. Develops and maintains a strong spirit of partnership.
- Conduct all communications and transactions with the utmost integrity, consistent with the KC Code of Conduct. Communicate fully with Senior Leaders, Peers, Support Partners etc. with matters that are appropriate.
- Ability to lead cross-functional teams working on major quality initiatives.
WORKING CONDITIONS:
- Travel up to 50% of the work time domestic and international.
- Work is completed in a flexible workplace environment that includes virtual, offices and manufacturing sites or laboratories.
- When at Manufacturing facilities or laboratories, may be exposed to environments ranging from dust, heat, noise, moisture up to clean room / laboratory environments. Proper personal protective equipment (PPE) must be worn at all times (may include safety glasses, facial protection, ear protection, hair nets, beard bags (if applicable), full gowning.
QUALIFICATIONS
Basic Qualifications
- A Bachelor’s degree in Science, Engineering, or equivalent degree.
- A minimum of 5 years developing and deploying, efficient and effective quality management systems and management processes, preferably across multiple geographic regions.
- Project management experience within a complex, matrix or multi-business organization.
- Working knowledge and experience with products requiring compliance with various regulatory or other technical requirements.
- Proven ability to effectively communicate in written and spoken English.
Preferred Qualifications
- Bachelor or Master degree in Science or Engineering in pharmaceuticals, chemistry, microbiology, technology or similar.
- 5+ years of experience in a Quality role in a medical device, pharmaceutical, cosmetic, sterile products or similar environment
- Sanitary Manufacturing Experience which includes Environmental Controls, GMP practices, Microbiological Investigations and problem solving. Working experience establishing Stability Programs for new products or changes to existing products.
- Working experience in Process Validation (water systems, blending/batching, cleaning and sanitization, or Sterilization Validation (Ethylene Oxid/ Gamma Radiation))
- A recognized quality management Certification is desirable such as ASQ Pharmaceutical GMP Professional
- A minimum of 5 years developing and deploying, efficient and effective quality management systems and management processes, preferably across multiple geographic regions.
- Understand and can apply concepts of Microbiological Quality and Good Laboratory Practices.
- Is able to influence and engage at varying levels of the organization.within a complex, matrix, multifunctional (R&E, Product Supply, Marketing) multi-business organization
- Ability to work and communicate in multiple languages is preferred.
- Knowledge of industry trends, emerging regulatory compliance requirements and best practices via internal/external benchmarking for integration considerations into business specific quality strategies.
- Ability to anticipate and meet deadlines, handling multiple simultaneous deadlines, prioritizing work, strong attention to detail, and the ability to retain confidential information.
- Collaborative, responsive, action-oriented and innovative problem solver
- Knowledge and experience using CI tools such as A3 strategy development, problem solving, and visual management.