Job Description The main mission of the Quality System Coordinator Cluster North is to provide leadership and oversight of Quality Compliance matters at an operational and regulatory complex commercial entity or multiple commercial entities in support of the quality system requirements associated with: pharmaceutical products, medical devices, combination products and biologics.
Responsibilities: Responsible for assuring that all the Quality Systems are being properly applied in the Cluster North.
Technical Support: Assuring compliance with cGMP.
Assure that the Quality Manual and Local Procedures are in place and maintained in alignment with Global Policies and local regulations.
Keep adequate records as required per regulations.
Responsible for partnering and overseeing support activities related to product actions in the affiliate. Oversee coordination and investigation of key quality systems (ie.
CAPA, product complaints) ensuring KPIs are being met. Resources: Assure the required resources are in place to comply with local regulatory requirements.
Keep track of the budget for the Quality System area.
Establish training requirements for suppliers, QA and non-QA personnel, and maintenance of a diverse and agile cross trained and effective team to ensure business continuity and compliance.
Responsible for keeping an accurate Training Matrix for QA and non-QA personnel and suppliers when applies.
Partner with stakeholders across the enterprise to gain a better understanding of processes external to QA to determine best steps forward. Assure key metrics are being monitored and met to ensure compliance and to drive continuous improvement including review of procedures and process to identify areas of opportunity and implement action plans. Perform assessments to determine compliance to processes, procedures and regulations to identify potential gaps and mitigate and implement improvements. Support internal and external quality inspections and audits including reporting, response to observations and tracking of action plans.
Quality management of supplier qualification program including performance monitoring for key suppliers, QTA management and assessments. Provide guidance and oversight for all activities governed by Good Storage and Distribution Practices including monitoring of controlled temperature and cold chain shipments.
Implement and maintain a Doc Tracking system to control all the records used by QA Cluster North Prepare the regional management review according to global policies.
Organize and present the slide deck to the Area Heads, Technical Director, QA Manager and General Managers.
Represent affiliate QA in regional, global and cross functional teams, projects and programs, as appropriate.
Implement actions to promote the continuous improvement of the Quality Management Systems in the organization.
Qualifications Excellent communication skills, both in Spanish and English Pharmacist with previous experience in similar positions (5+ years).
Thorough knowledge of cGMP, cGLP and applicable regulations.
Appropriate English level.
Knowledge and familiarity with product, process, and both internal and external customer requirements and regulations. Knowledge of QA systems and GxP compliance requirements including regulations and standards affecting device, biologics and pharmaceutical products.
Strong influencing, motivational, interpersonal and relationship building skills with staff and at all levels. Ability to make operational and business decisions with minimal direction. Excellent written and oral communication skills. Proficiency in English. Ability to think strategically and enterprise wide to ensure compliance and business needs are met or exceeded. Negotiation skills, effective collaboration and ability to anticipate needs and requirements, managing matrix teams. Strong computer skills and knowledge of enterprise systems such as SolTraqs, TrackWise, Attache, OneVault and SAP Additional Information AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVie's policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because 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, status as a protected veteran, or any other legally protected group status.
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