About this role
Oversight of the activities at the Third Parties for all aspects, including but not limited, to the QualityManagement 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. University Degree in Chemistry, Microbiology, Pharmaceutical Science or related field.Minimum of seven (7) - ten (10) years of progressive management experience; preferably in thepharmaceutical industry and including engagement of outsourced service providers such as manufacturers and packagers.Extensive knowledge of the Regulations/GMP’s and experience with local regulatory authorities as well as major international regulators such as FDA. Knowledge of other global regulatory authorities is an asset.The ability to influence vertically and horizontally across the organization is essential.Strong knowledge of applicable local regulations as well as major international GMP, ICH guidelinesResearching, interpreting and analyzing reports, compliance requirements, regulations, contracts and data.Analyzing and troubleshooting problems, identifying solutions, recommending and implementing methods, procedures or techniques for resolutionPharmaceutical processes, principles, practices and their application.Demonstrated leadership in managing projects and/or product launches and ability to work independently.Must be able to travel, locally and internationally. Travel is estimated to be 20%-25%. AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
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