My client is a Fortune 500 company looking to expand their presence in the region. Their product portfolio is highly used across every stage of research, development and production activities in the industries they serve.
This role will be responsible for providing strategic direction and alignment for the Quality Assurance (QA) and Quality Control (QC) functions at manufacturing sites located within the region.
- Assures strategic and tactical activities of quality assurance across the regional manufacturing
- Develop strategic and tactical plans and initiatives for international, national, and industry-specific quality management and regulatory systems with strong focus on regulated industries
- Sets the strategic direction for the Quality organizations in place at each manufacturing site to
ensure compliance with regulatory agencies industry requirements
- Support the implementation of the Global Quality Management Systems to ensure continued compliance
- 10+ years of experience in some combination of Quality and Regulatory roles, some portion of which must include experience in a regulated industry
- Extensive knowledge of Good Manufacturing Practice regulations (including FDA cGMPs - 21CFR
Parts 820, 210, 211, EMA GMPs, and other international regulations), ISO 9001, and ISO 13485
- Demonstrated leadership ability in a team environment; ability to work effectively with people at all levels in an organization
If you are looking to develop your career alongside a reputable organization, please apply with your CV.