Quality Manager
Alexandria, OH · On-site
Assess current quality processes, systems, and data flows to identify gaps, inefficiencies, and improvement opportunities. * Define and prioritize essential quality management capabilities based on ...
63 Katalyst Clinical Data Manager Jobs Hiring Near You
Quality Manager
Alexandria, OH · On-site
Assess current quality processes, systems, and data flows to identify gaps, inefficiencies, and improvement opportunities. * Define and prioritize essential quality management capabilities based on ...
CSV Engineer
Columbus, OH · On-site
Perform risk assessments to determine validation approach and ensure appropriate testing of system functionality, data integrity, and audit trail review. * Manage system change control, deviations ...
CSV Engineer
Columbus, OH · On-site
Perform risk assessments to determine validation approach and ensure appropriate testing of system functionality, data integrity, and audit trail review. * Manage system change control, deviations ...
C&Q Engineer
New Albany, OH · On-site
Manage punch list identification, tracking, and resolution through to system acceptance and ... Maintain accurate and complete C&Q records in compliance with site documentation standards and data ...
C&Q Engineer
New Albany, OH · On-site
Manage punch list identification, tracking, and resolution through to system acceptance and ... Maintain accurate and complete C&Q records in compliance with site documentation standards and data ...
Katalyst Jobs Information
What is it like to work at Katalyst?
Katalyst appears to be a collaborative and innovative company that values creativity and teamwork, fostering an environment where employees can share ideas and work together to achieve common goals.
The company's structure and work environment seem to be designed to support a dynamic and agile approach, with a focus on delivering high-quality results and driving business growth. Katalyst's mission is centered around helping businesses and organizations succeed through strategic partnerships and tailored solutions.
Working at Katalyst may appeal to individuals who are passionate about innovation, collaboration, and making a meaningful impact in their industry, as the company offers opportunities for professional growth, skill development, and contributions to a dynamic and forward-thinking organization.
The company's structure and work environment seem to be designed to support a dynamic and agile approach, with a focus on delivering high-quality results and driving business growth. Katalyst's mission is centered around helping businesses and organizations succeed through strategic partnerships and tailored solutions.
Working at Katalyst may appeal to individuals who are passionate about innovation, collaboration, and making a meaningful impact in their industry, as the company offers opportunities for professional growth, skill development, and contributions to a dynamic and forward-thinking organization.
What makes Katalyst an attractive place to work?
Katalyst is a forward-thinking company that has established itself as a leader in its industry, known for its commitment to innovation and customer satisfaction. The company's work environment is characterized by a collaborative and dynamic atmosphere, where employees are encouraged to share ideas and work together to drive progress. Joining Katalyst offers opportunities for professional growth and development, as well as the chance to contribute to meaningful projects that can have a lasting impact.
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Job description
Job Summary:
Roles & Responsibilities:
Education & Experience:
The Quality Manager (Pharma/Medical Domain) is responsible for leading and optimizing quality management systems across regulated manufacturing environments. This role focuses on aligning stakeholders, evaluating current quality processes and systems, and defining practical, business-aligned capabilities to enhance quality operations. The position plays a key role in driving strategic improvements in areas such as CAPA, non-conformance, audits, supplier quality, and laboratory systems while ensuring compliance with regulatory standards. The Quality Manager will also develop a phased roadmap to modernize and streamline quality processes within the existing technology landscape.
Roles & Responsibilities:
- Align cross-functional stakeholders on priority quality use cases such as environmental monitoring, swab testing, non-conformance management, CAPA, audits, supplier quality, and LIMS.
- Assess current quality processes, systems, and data flows to identify gaps, inefficiencies, and improvement opportunities.
- Define and prioritize essential quality management capabilities based on business needs versus optional enhancements.
- Evaluate how required capabilities can be integrated within the existing technology ecosystem, minimizing unnecessary tool implementation.
- Develop and recommend a phased roadmap with clear priorities, milestones, and actionable next steps for quality transformation.
- Lead initiatives to enhance Quality Management Systems (QMS) across manufacturing operations.
- Ensure compliance with regulatory requirements applicable to pharma, medical device, and food-regulated industries.
- Collaborate with IT, operations, and quality teams to improve system interoperability and data-driven decision-making.
- Support continuous improvement initiatives and promote best practices in quality and compliance.
Education & Experience:
- Bachelor's degree in Engineering, Life Sciences, Quality Management, or a related field (Master's preferred).
- Minimum of 10+ years of experience in Quality Management within pharmaceutical, medical device, or food-regulated manufacturing environments.
- Strong experience with Quality Management Systems (QMS), including CAPA, non-conformance, audits, and supplier quality.
- Experience working with Laboratory Information Management Systems (LIMS) and environmental monitoring processes is highly preferred.
- Proven ability to assess and optimize business processes, systems, and data workflows.
- Familiarity with regulatory standards such as FDA, GMP, and other applicable quality regulations.
- Strong stakeholder management, communication, and leadership skills.
- Experience in driving strategic initiatives and developing implementation roadmaps.