About AbbVie AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Purpose: Senior Manager, Product QA, Post Market Surveillance manages a business unit of complaint analysts that are responsible for the processing of product quality complaints and adverse events associated to product quality. The scope of activities includes investigating and closure of product complaints for AbbVie’s products. This role serves as a subject matter expert and representative for complaint handling and is a primary contact during audit inspections and assessments by regulatory agencies. In addition to these responsibilities the person is also responsible for the quality of any assigned products for biologics and/or combination products to ensure business objectives are met by assuring compliance to local, divisional and corporate policies and external agency regulations worldwide. Responsibilities: •Hire and lead staff of Managers and Complaints Analysts to accomplish quality system and compliance goals associated with the complaint handling function. •Provide oversight of the global complaint handling processes, complaint metrics, complaint tracking and/or trending and associated CAPA. Assess and differentiate events for their seriousness and, depending on the findings, notify appropriate management personnel. •Manage the risk evaluation process including but not limited to overall process management, tracking and trending of product complaints. •Responsible for implementing and maintaining the effectiveness of the quality system through development, implementation and maintenance of Quality policies, procedures and systems to support and maintain thoroughly documented complaint investigations. •Maintain compliance to global regulatory requirements for complaint registration, investigation and insure timely review and reporting of product complaints, including interfaces with third party and AbbVie affiliates to ensure complaint compliance. •Interface with regulatory agencies involving post marketing field related problems and product inquiries and during routine site / process inspections. •Provides strategic and functional leadership of all quality assurance activities to support AbbVie’s Third Party Manufacturing, In Licensing relationships, Co Marketing relationships, and Intellectual Properties. •Acts as the primary quality representative for the global supply chain pertaining to external manufacturing business relationships and builds and maintains relationships with Operations, TPM Business Alliance, Commercial, Global Supply Chain, Domestic and International AbbVie Plants and Affiliates, Regulatory Affairs, R&D, and MS&T to ensure alignment on strategic initiatives. •In concert with Regulatory Affairs, develops the appropriate regulatory strategies for product brands and makes key decisions on product quality/compliance and regulatory conformance issues for sterile, biological, liquid, solids, and/or device products and elevates medium and high risk events to AbbVie management. Performs final quality release of manufactured product lots, for products and/or product lines the TPM manufactures. •Supports development of the legal supply agreements/contracts/letters of intent to insure the appropriate quality, compliance, and regulatory aspects are met for the products and services covered and manage the organizations actions within the legal boundaries of these documents. Ensures alignment of Quality/Technical Agreements with the legal contracts and that the commitments of the quality/technical agreements are being fulfilled. Helps facilitate resolution in cases where they are not. . Qualifications •Bachelor's degree in Science or equivalent + 10 years of relevant experience OR Master's degree in Science or equivalent 8+ years of relevant experience is required •Knowledge in Product Quality Control, Quality Operations, and Regulatory requirements. •Ability to make operational and business decisions with minimum direction from immediate manager. •Prior experience in people and budgetary management. •Has the ability to interact and establish positive interaction with internal/external customers. •Experience with quality systems required with emphasis on global complaint handling and be able to handle and prioritize multiple diverse situations. •Strong communication skills, including the ability to understand and influence individuals in specialized and technical fields and be able to resolve issues involving complaint handling, stability program, change control practices and policies and procedures. •Possesses knowledge and skill set to operate within an environment that requires a high degree of urgency, strong analytical and problem solving skills, positive interpersonal skills, ability to manage multiple complex tasks simultaneously, and capable of performing as leaders, members and individuals. . External: Patients, Patient Assistance Programs, Third Party Manufacturers Internal: Pharmacovigilance, AbbVie Plants and Affiliates, Product Quality, Customer Service, Commercial, Supply Chain, R&D, MS&T, Regulatory Affairs Significant Work Activities Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day) Travel No Job Type Experienced Schedule Full-time Job Level Code IC Equal Employment Opportunity At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.