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Provide support for GMP QA activities occurring mostly in US with some NL and IMP Logistics (EU) facilities interactions. To include, Inspection Facilitation, Self Inspections, Vendor Audits, Internal Process Audits and support GMP documentation review as needed (e.g. Responses, Annual Testing, Quality Agreements, Procedural Documentation, Deviations, CAPA, Qualification, Risk Assessments)
- Participates in the selection, hiring and training of new QA staff.
- May functionally manage 1-15 Auditors and/or manage other managers
- Leads QA auditors’ team by providing clear team / individual goals and expectations and ensuring that each member of the auditing staff understands her/his responsibility to know and follow all SOPs and corporate policies
- Contributes to the development and ensures implementation of the Quality Assurance operating plan
- Makes recommendations for and assist in the development of Quality Assurance policies, procedures and practices. Maintains awareness of new system implementations, Quality Assurance and technological advancements.
- Actively pursues process improvement opportunities. Leads to establish quality improvement goals and monitors compliance to accepted processes and practices, instituting any new or changed procedures and measure their results.
- Assists in the definition of the QA's strategic direction. May be asked to communicate with senior management on long range issues, assists in ensuring management objectives are achieved.
- Utilizes tools and methodologies to improve individual effectiveness and to increase efficiencies in the QA process.
- Reviews requirements and specifications to identify potential risks to quality, identify ambiguities or omissions, and ensure testability. Works with project team to recommend and implement steps to mitigate identified risks.
- Ensures team adherence to established standards and methodologies.
- Develops and sustains appropriate relationship with peers and other QA team members.
- Provides cost estimates for contracted QA services proposals
- Develops and mentors QA managers
- Proposes projects designed to increase quality or address a GxP deficiency.Provides regular status reports on quality observations to Operational Management, as requested.
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