Mgr Quality

Mgr Quality

The position provides Quality oversight and support for Webster Groves manufacturing facility. The position will provide leadership and support for continued operation of the facility. The oversight includes signature authority, with responsibility for escalating high risk issues to management. The position is responsible for decisions relating to quality and project actions. The position is responsible for project decisions, risk identification, risk mitigation and cross-functional support with entire team (operations, regulatory affairs, science and technology, etc). The main result of the incumbent is to ensure compliance with cGMP, regulatory and internal requirements regarding the manufacturing, testing and distributing of products as well as projects such as tech transfer, new product introductions and inspection readiness.

Essential Functions :

• Provide leadership and support for the cGMP facility
• Provide QA oversight, including but not limited to :
• Change management
• Investigations (process, complaint, and laboratory)
• Product release
• In process controls
• Annual Product Review
• Master documents (batch records, methods, labels, etc)
• Facility / Equipment Qualification and validation (process / cleaning)
• Stability data review / stability coordination
• CAPA
• Develop and execute validation and compliance strategy for Webster Groves commercial plant
• Conducts / Coordinates supplier audits and supports audits as part of the audit team, as needed
• Identify, develop and execute project plan and timelines to achieve desired results
• Liaise with other intracompany facilities (Hobart, STLP) for laboratory testing and other needed support
• Participate actively in cross-functional teams supporting the Webster Groves commercial plant and projects
• Serve as leading technical expert for key quality or compliance areas
• Create, approve, and implement quality system procedures associated with the product realization process as well as procedures associated with facility management and oversight
• Ensure facility is prepared for FDA and other regulatory body inspections
• Support scorecard development, maintenance, reporting and action / project development from scorecards
• Evaluate and provide risk-based QA decisions on all systems and issues that are / may be affected by regulatory or cGMP requirements escalate to senior leadership as appropriate

Minimum Requirements :

Education :

Experience :

Skills / Competencies :

Other Skills / Competencies :

Organizational Relationships / Scope :

Working Conditions :

Disclaimer :

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.