- Reference: GY45341
- Job Type: Permanent
- Location: Galway
- Category: Engineering, Technical & Manufacturing
The Quality Assurance/Regulatory Affairs Manager is the Senior quality position of International Limited reporting to VP EMEA, Quality and Compliance.
- Possesses and applies a broad expertise of Quality and Regulatory, and its application to contribute to the development of company objectives and maintain a compliant Quality Management System.
- Possesses advanced knowledge of the organization’s operations and practices to enable informed decisions, and provide direction to Quality team and other functional areas.
- Responsibility for management of delivery of projects originated in QA or Quality deliverables of business wide projects.
- Provides point of escalation for Quality impacting business operations.
- Operates with business latitude and quality focus. Determines and develops approach to solutions where situations may have little or no precedent, with new and expanding business operations.
- Makes prompt and sound decisions under conditions of uncertainty, that produce effective end results. Applies risk assessment techniques in such circumstances.
- Drives business improvements through management, mentoring and support of the QA Team.
- Drives compliance cross functionally in alignment with the regional objective for collaboration and multi-site ISO13485 certification.
- Maintains quality agreements and collaboration with Third Parties both intercompany and external.
- Manages the budget and resources of the department to ensure funds and resources are applied to fulfil the strategic goals of the company.
Skills, Experience and Qualifications:
- Bsc or equivalent in Lifesciences.
- A minimum of 7 years experience with 3-5 years of progressively responsible positions.
- A broad knowledge of quality and regulated environments and industry regulators.
- Excellent communication skills (both verbal and written).
- Ability to manage or co-ordinate high performing teams to achieve desired outcomes.
- A capacity to influence across regions and territories to gain acceptance and accountability of multi-site collaborations.
For a confidential discussion and more information on the role/company please email your CV to: firstname.lastname@example.org