AbbVie
Quality Systems and Third Party Contract Lead
AbbVie’s mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to impact people’s lives across key therapeutic areas – immunology, oncology, neuroscience, eye care – and products and services in our Allergan Aesthetics portfolio. Job Description This position leads and maintains compliant Documentation Quality Systems (QS) according to AbbVie policies, procedures, and applicable government regulations. The role manages the documentation review board to process and update plant procedures, Process Control Records, Specifications, Test Methods, and other GMP documentation. It provides leadership to a team for creating and updating material codes in the SAP inventory system and the electronic batch record recipes in the POMs system. The Quality Systems and Third-Party Contractor (TPC) role is the main QA point of contact with TPC to manage regulatory compliance and business continuity requests in a professional, compliant, and timely fashion. It also oversees plant documentation retention center activities. Responsibilities
Organize, administer, train, develop, and supervise personnel under the Documentation Center area, including hiring, training, performance evaluation, and wage adjustments. Oversee the Documentation Management System and Change Request System to update plant procedures, Process Control Records, Specifications, Test Methods, and other GMP documentation, and manage the documentation periodic review process. Issue electronic batch records to manufacturing areas in the POMs system and create/update material codes in the SAP system. Serve as the main QA site reviewer/approver for all new and revised global and local specification documents. Identify and isolate quality problems, ensure corrective action is taken, and maintain the documentation change control system. Lead and manage quality aspects with clients (Third Party contractors), including quality agreements, event discussions, change management process, and regulatory and compliance requests. Analyze, manage, and maintain data for cycle times, touch times, and tasks/process lists for continuous improvement of QA processes performance. Act as QA Compliance Manager when present, using independent judgment to make quality decisions related to the QA Compliance area. Assure fulfillment of environmental, health, and safety (EHS) requirements and compliance obligations, promote continuous improvement, and consider EHS aspects during design and change process. Qualifications
Bachelor’s degree in Science, Engineering, or related field is required. Eight (8) years of experience in the pharmaceutical, biologics, or chemical industry in Quality Systems, Quality Operations, or Third Party Contracting. Three (3) years of experience managing direct reports is required. Strong knowledge of Quality regulations and standards for Pharmaceutical Industry (e.g., Q7A, EU, Health Canada GMP, FDA regulations and guidelines). Excellent verbal and written communication in both English and Spanish. Must be flexible and adapt to changes efficiently without disrupting area output performance. Knowledge of GMP, safety regulations. Computer literate including SAP, Microsoft Office (Excel, PowerPoint, Word). Capable of handling multiple priorities, strong problem solving, interpersonal and communication skills. Key Stakeholders
Local and Global AbbVie, main QA contact with TPC QA Quality/Regulatory middle management functions. Benefits
Comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance, and 401(k) to eligible employees. Short-term and long-term incentive programs available. Equal Opportunity Employer
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 applicants seeking a reasonable accommodation, click here to learn more: https://www.abbvie.com/join-us/reasonable-accommodations.html
#J-18808-Ljbffr
AbbVie’s mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to impact people’s lives across key therapeutic areas – immunology, oncology, neuroscience, eye care – and products and services in our Allergan Aesthetics portfolio. Job Description This position leads and maintains compliant Documentation Quality Systems (QS) according to AbbVie policies, procedures, and applicable government regulations. The role manages the documentation review board to process and update plant procedures, Process Control Records, Specifications, Test Methods, and other GMP documentation. It provides leadership to a team for creating and updating material codes in the SAP inventory system and the electronic batch record recipes in the POMs system. The Quality Systems and Third-Party Contractor (TPC) role is the main QA point of contact with TPC to manage regulatory compliance and business continuity requests in a professional, compliant, and timely fashion. It also oversees plant documentation retention center activities. Responsibilities
Organize, administer, train, develop, and supervise personnel under the Documentation Center area, including hiring, training, performance evaluation, and wage adjustments. Oversee the Documentation Management System and Change Request System to update plant procedures, Process Control Records, Specifications, Test Methods, and other GMP documentation, and manage the documentation periodic review process. Issue electronic batch records to manufacturing areas in the POMs system and create/update material codes in the SAP system. Serve as the main QA site reviewer/approver for all new and revised global and local specification documents. Identify and isolate quality problems, ensure corrective action is taken, and maintain the documentation change control system. Lead and manage quality aspects with clients (Third Party contractors), including quality agreements, event discussions, change management process, and regulatory and compliance requests. Analyze, manage, and maintain data for cycle times, touch times, and tasks/process lists for continuous improvement of QA processes performance. Act as QA Compliance Manager when present, using independent judgment to make quality decisions related to the QA Compliance area. Assure fulfillment of environmental, health, and safety (EHS) requirements and compliance obligations, promote continuous improvement, and consider EHS aspects during design and change process. Qualifications
Bachelor’s degree in Science, Engineering, or related field is required. Eight (8) years of experience in the pharmaceutical, biologics, or chemical industry in Quality Systems, Quality Operations, or Third Party Contracting. Three (3) years of experience managing direct reports is required. Strong knowledge of Quality regulations and standards for Pharmaceutical Industry (e.g., Q7A, EU, Health Canada GMP, FDA regulations and guidelines). Excellent verbal and written communication in both English and Spanish. Must be flexible and adapt to changes efficiently without disrupting area output performance. Knowledge of GMP, safety regulations. Computer literate including SAP, Microsoft Office (Excel, PowerPoint, Word). Capable of handling multiple priorities, strong problem solving, interpersonal and communication skills. Key Stakeholders
Local and Global AbbVie, main QA contact with TPC QA Quality/Regulatory middle management functions. Benefits
Comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance, and 401(k) to eligible employees. Short-term and long-term incentive programs available. Equal Opportunity Employer
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 applicants seeking a reasonable accommodation, click here to learn more: https://www.abbvie.com/join-us/reasonable-accommodations.html
#J-18808-Ljbffr