The Sr Manager Quality Systems is responsible for providing quality assurance support for some or all of the following manufacturing processes: pharmaceutical products, medical devices, combination products and biologics. This role will develop and support the strategic direction to ensure business objectives are met by managing large and/or complex initiatives. This position will also translate strategy into tactical objectives to deliver strategic plans and regulatory updates. Specific areas of support may include the Document Center, Device QA, Labeling, Validation, Training and CAPA. This position will ensure that all product, process or system related quality activities from supplier and TPM management to raw material inspection through shipment of final product are in compliance with Corporate and governmental regulations.
Ensure proper development, integration and support of quality regulations: drug, biologics, device and/or combination products.
Responsible for initiation, selection, coordination and management of quality systems projects. Lead project teams and/or direct staff in planning, preparation, review and approval of quality documentation.
Responsible for implementing and maintaining the effectiveness of the quality system for drug, biologics, device and/or combination products including compliance with Corporate policies, processes and procedures.
Design effective quality systems, procedures and/or processes within cross functional teams to ensure compliance as well as efficiency throughout our quality system. May be required to prepare and present data during regulatory audits (FDA, EMA, Anvisa, etc) and internal audits.
Manage and oversee the interrelated function activities including design control with R&D, Manufacturing
Science and Technology (MS&T), Supply Chain, Program Management, Commercial, Medical, Pharmacovigilance, and Regulatory Affairs.
Lead quality system elements, training, continuous improvement, and tactical support across functions, plants, and affiliates.
Oversee new product introduction for pharmaceutical products, biological products, medical devices, or combination products. Support design changes to existing medical devices and combination products.
Interact with internal and external partners for development of best practices in our quality systems and procedures.
Review assessments to determine compliance to processes and regulations to identify potential gaps and mitigate and implement improvements within our quality system.
Oversee the implementation and management of training and education programs for various aspects of quality assurance.
Bachelor’s Degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering or other technical/scientific area.
10+ years’ experience in quality assurance, quality oversight or relevant experience.
Proven managerial leadership of technical professionals and/or in leading cross-functional teams.
Technical knowledge in as many of the following areas as possible: Quality, Regulatory, Process Sciences,
Knowledge and familiarity with product, process, equipment, and facilities of pharmaceutical, biological or device related products.
Knowledge of QA systems and GMP compliance requirements including regulations and standards affecting device, biologics, and pharmaceutical products.
Experience working and/or managing in both team setting and independently. Works well with minimal manager guidance while able to manage own time and/or teams effectively.
Strong oral (with all levels of management) and written communication skills needed.
Excellent interpersonal skills a plus.
Can create strategic plans integrated into the overall quality system to deliver large and complex programs or projects.
Internal Number: 2003314
AbbVie is a global, research-driven biopharmaceutical company committed to developing innovative advanced therapies for some of the world’s most complex and critical conditions. The company’s mission is to use its expertise, dedicated people and unique approach to innovation to markedly improve treatments across four primary therapeutic areas: immunology, oncology, virology and neuroscience. In more than 75 countries, AbbVie employees are working every day to advance health solutions for people around the world. For more information about AbbVie, please visit us at abbvie.com/careers.