Sr. Manager, Third Party Quality AssuranceControl

• 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 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 Companys 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.

Qualifications :

• University Degree in Chemistry Microbiology Pharmaceutical Science or related field.
• Minimum of seven (7) - ten (10) years of progressive management experience; preferably in the
• pharmaceutical industry and including engagement of outsourced service providers such as manufacturers and packagers.
• Extensive knowledge of the Regulations/GMPs 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 guidelines
• Researching interpreting and analyzing reports compliance requirements regulations contracts and data.
• Analyzing and troubleshooting problems identifying solutions recommending and implementing methods procedures or techniques for resolution
• Pharmaceutical 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%.

Additional Information :

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. 

US & Puerto Rico only - to learn more visit  & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:

Work :

No

Employment Type :

Full-time