Job Description

Oversight of the activities at the Third Parties for all aspects, including but not limited, to the Quality
Management System, deviations, CAPAs, stability, annual product review, complaints, validation protocols, method transfers, change controls, quality agreements and oversight of outsourced activities/third party production.
Lead investigations into product non-conformances and deficiencies. Assure that all investigations are properly documented, and that corrective actions for prevention of reoccurrence are completed in a timely manner. Apply risk management principles in data analysis, decision-making and reporting processes within the areas of responsibility.
Assure responsible Third Parties are compliant with cGMPs, regulatory and corporate compliance requirements and contractual agreements.Support, as appropriate, communications with Regulatory Authorities including both written and verbal, such as for Field Alerts.
Responsible for ensuring all third party related Agency communication and/or notification activities are consistent with regulatory and company requirements.
Support, if needed, the Third Party during any regulatory agency inspections for Company’s products.
Negotiate and establish quality agreements and provide quality input for other business agreements for third party manufacturers, suppliers and partners.
Monitor quality metrics/ key performance indicators for contract sites and contribute to Business Review and Quality Management Review meetings.
As a member of the TPCQ team, develop and implement Standard Operating Procedures (SOP's) to assure compliance with regulations, Allergan corporate standards and contractual agreements, as necessary.
Perform other related duties or projects, as assigned.

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Sr. Manager, Third Party Quality Assurance/Control

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AbbVie is hiring a

Sr. Manager, Third Party Quality Assurance/Control

Job Description

Join Swish Analytics

Create a Job Alert

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