We are looking for a talented and highly driven QA Director to join our team.
Responsibilities:
- Management of all Quality activities in the company.
- Initiate, monitor, and verify the effective implementation of the Quality Management .
- System and Regulatory requirements that impact processes, products, or services.
- Maintain Dot Compliance internal QMS.
- Maintain the quality documents and records.
- Manage the validation team and product validation.
- Responsibility for review and approval of relevant documentation such as SOPs,
- Validation docs etc.
- Responsibility for maintaining ISO 9001 quality certification.
- Responsibility for supporting customer audits.
- Responsibility for compliance with CFR part 11, Annex 11, and other guidelines.
- Serve as company privacy officer as per privacy guidelines
Requirements:
- B.Sc. or equivalent degree.
- At least 5 years of experience as QA Manager in the Medical Device/Pharma/Biotech/Healthcare arena -Mandatory.
- Tech Savvy and experienced in software validation methodologies.
- High sense of ownership and ability to deliver independently.
- Outstanding leadership, communication, interpersonal, and analytical skills with the ability to successfully lead multiple teams in highly dynamic matrix.
- Analytical and technical skills and experience with supplier audits.
- Excellent English (Verbal and Written), Outstanding communication skills.
- Must use creativity, independent judgment and organizational and problem-solving skills.