Global Process and Technology Audit Manager
2 months ago
Essential Functions
- Develop and implement process improvement initiatives
- Analyze current processes and identify areas for improvement
- Design and implement new processes to increase efficiency and productivity
- Manage process documentation and ensure compliance with company standards
- Collaborate with cross-functional teams to implement process changes
- Train employees on new processes and procedures
- Monitor and measure process performance and report on progress
- Responsible for taking action based on audits and CAPA findings
- Identify and mitigate process risks and issues
- Lead process improvement projects from start to finish
- Partner with Quality and Regulatory to ensure processes meet regulatory needs
- All other duties and responsibilities as assigned
Skills needed to be successful
- Proven work experience as a Process Manager or similar role
- Excellent understanding of process improvement methodologies
- Strong analytical and problem-solving skills
- Ability to lead and manage cross-functional global teams
- Excellent communication and interpersonal skills
- Ability to work under pressure and meet deadlines
- Excellent computer skills, including proficiency in Microsoft Office and process mapping software
- Solid understanding of Agile software development methodologies
- Certification in process improvement methodologies such as Lean Six Sigma is a plus
- Previous experience in project management is a plus
Required Experience & Education
- Bachelor's degree in Business Administration, Engineering, or a related field. Master's degree in Business Administration or a related field is preferred.
- This is a senior position that requires a minimum of 5 years of experience in process management or related field.
- Previous experience with requirements and certifications required for FDA or any other governing bodies for e.g. ISO 13485 .
- Experience in a scientific testing or healthcare field is a plus.
Supervisory Responsibilities
- None
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