Director of Quality Assurance and Compliance
1 week ago
Actalent is seeking a highly experienced Director of Quality Assurance and Compliance to lead our quality assurance team. The ideal candidate will have a strong background in quality assurance and compliance, with experience in managing internal audit programs and inspections/audits by external regulatory agencies.
The Director of Quality Assurance and Compliance will be responsible for ensuring the smooth and continuous operations of our site quality system, quality control, and assurance inspection for in-process and finished goods. They will also oversee process audits and final product release documentation, advise and facilitate failure investigations, and share compliance methodologies for manufacturing of valve assemblies.
The successful candidate will have a proven track record in people management, with experience in supporting/implementing FDA's Case for Quality program. They will also have excellent documentation and communication skills, as well as interpersonal relationship skills, including negotiating and relationship management skills with the ability to drive achievement of objectives.
The Director of Quality Assurance and Compliance will be responsible for managing supervisors, managers, and/or experienced professionals and activities, including quality control, exception handling, process audits to achieve release and compliance expectations. They will also develop a robust talent development plan in alignment with functional growth strategies of the department.
The ideal candidate will have a Bachelor's Degree in a related field and experience in managing internal audit programs and inspections/audits by external regulatory agencies for class II/III medical devices. They will also have a proven successful project management leadership skills and expertise in both Microsoft Office Suite, including advanced Excel and related systems.
Actalent is an equal opportunity employer and welcomes applications from diverse candidates. If you would like to request a reasonable accommodation, please email [ ] for other accommodation options.
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