Quality Director - IT/IT Services

Mandated Experience:

Exposure to SEI CMMI experience, Client Audits and ISO is a must.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

- Develop, maintain and improve the QMS

- Institutionalize the quality process

- Responsible for conducting Quality Improvement Programs and taking to closure

- Develop and maintain the Annual IQA and co-ordinate the Audit Process

- Verify audit results and initiate necessary Preventive and Corrective Action, Organization wide

- Publish and Audit results across the organization

- Maintain audit-related documents

- Approve process documents

- Ensure availability of certified auditors to effectively conduct the audit program

- Acquire and maintain knowledge of applicable Global Health Authority regulations

- Train the team members as assigned

- Perform any other QA related activities as assigned

- Manage training management function within Synowledge.

- Successful in Client (Quality) Management roles or been a Quality consultant to Clients system.

SPECIALIZED KNOWLEDGE AND SKILLS:

- Basic competence with medical and therapeutic terminology

- In depth working knowledge about all audits:

- First party Audits (internal Quality Audits)

- Second Party Audits (Customer auditing on Supplier)

- Third Party Audits (Audit by Certification body)

- Snap audits

- Audit types (Adequacy, Compliance)

- Audit Principles (Etiquette, Human Relationship issues)

- Audit Interviewing Skills

- Through understanding of Quality Management System

COMMUNICATION SKILLS:

- Requires a proactive approach and excellent written/oral communication and interpersonal skills.

- Strong interpersonal skills required to interact with clients, management, and peers effectively.

- Problem/resolution and information/action plans.

TECHNICAL SKILLS:

- Should be familiar with MS Office Tools

OTHER SKILLS:

- The ability to contribute to a team environment with a high degree of professionalism and skill.

- Demonstrated flexibility within a dynamic, fast paced, cross-functional team.

- Demonstrated ability to complete multiple tasks concurrently and deliver results in a fast-paced environment. Ability to educate/ train the team members as needed.

- Contributing to the ongoing enhancement of QMS process and SOP’s including trainings.

- Ability to think analytically, Attention to detail

- Ability to work on problems of diverse scope in which analysis of data requires evaluation of identifiable factors

- Ability to exercise judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions

- Ability to prioritize and multi-task

- Ability to resolve complex problems positively and professionally

- Ability to interact with all levels of management

- Demonstrated leadership skills in a multi-disciplinary team environment

- Strong organizational, planning and follow-through skills

EDUCATION & EXPERIENCE:

- BE, BTECH/MCA

- More than 6+ years QA Lead Experience.

- Added advantages will be certification to leading process and compliance standards.