Mgr Quality & Process Improvement
About The Position
Sets strategies for transforming business processes and operational tools to achieve global excellence. Ensures products, services, and operations adhere to established quality standards and regulatory requirements. This role involves developing and implementing quality management systems, conducting audits, and driving continuous improvement initiatives. They also monitor regulatory changes, manage compliance programs, and work with various stakeholders to ensure overall adherence to quality and compliance standards. Provides technical expertise and advice to senior/executive management on current and emerging systems trends, practices, opportunities and risks within area of expertise. Delivers analysis, interpretation and application of complex information in order to influence optimal business decisions. Leads high impact cross-functional projects and initiatives. Is future oriented and drives strategic planning. Influences and supports cross-functional project teams in order to achieve optimal results for the business.
Requirements
- Bachelor’s degree/equivalent in healthcare quality or safety, transportation, business, information systems, computer science, science or other scientific or quantitative discipline.
- Five (5) years’ minimum experience required in pharma quality in manufacturing, laboratories or distribution or closely related experience and including experience in business, transportation, logistics or supply chain management.
- Deviation experience.
- Proficient Office 365 skills required.
- Strong basic management, human relations, project management, analytical and communication skills required.
- Ability to train, communicate and present clearly, both orally and written to all business levels.
- Must be able to collaborate with business areas, customers, vendors, systems users, and technical developers.
- Knowledge in European regulatory compliance.
- Bachelor’s degree in business, engineering, computer science, or a related quantitative discipline.
- Five (5) years of relevant experience and one (1) year of management experience within the last five years.
- Management, human relations, project management, analytical, and communication skills.
- Proficiency in various computer applications is essential.
Nice To Haves
- Lean/Six Sigma training preferred.
Responsibilities
- Maintaining quality management systems (QMS) that meet both internal standards and external regulatory requirements.
- Performing internal and external audits to assess compliance with quality standards, regulations, and company policies.
- Staying up to date on relevant regulations and industry standards, including CEIV, IATA, ISO, GDP and other specific requirements.
- Developing and implementing comprehensive compliance programs, including policies, procedures, and training materials.
- Investigating quality-related incidents, deviations, and non-conformities, and developing corrective and preventive actions (CAPA).
- Identifying areas for improvement in quality processes and systems and implementing solutions to enhance efficiency and effectiveness.
- Providing training to employees on quality and compliance-related topics.
- Preparing reports on quality and compliance performance and communicating findings to relevant stakeholders.
- Working with various departments, such as R&D, production, and marketing, to ensure quality and compliance throughout the product lifecycle.
- Identifying and assessing potential quality and compliance risks and developing mitigation strategies.
- Plans, organizes, and directs the quality management processes and systems.
- Provide Quality guidance, support, and advice to quality team, internal stakeholders and external customers, vendors and regulatory bodies.
- Perform functions utilizing electronic quality systems with an understanding of regulatory requirements.
- Identify, manage and perform continuous improvement projects to ensure customer satisfaction and business continuity.
- Performs or reviews deviation investigations and CAPAs.
- Performs or reviews Quality Agreements and Supplier Qualifications.
- Performs training included but not limited to GDP, IATA and CEIV certifications.
- Performs other duties as assigned.
- Delivers analysis, interpretation and application of complex information in order to influence optimal business decisions.
- Leads high impact cross-functional projects and initiatives.
- Is future oriented and drives strategic planning.
- Influences and supports cross-functional project teams in order to achieve optimal results for the business.
Benefits
- Comprehensive benefits
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What This Job Offers
Job Type
Full-time
Career Level
Manager
