Quality Manager

Quality Manager (Pharma/Medical Domain)

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.