Purpose:

　　The Affiliate QA Manager is responsible for providing leadership and oversight of Quality Compliance matters at the commercial entities in Affiliate, in support of quality system requirements associated with: pharmaceutical products, medical devices, combination products and biologics. Specific areas include Storage and Distribution, Product Complaints, potential quality events/product shortage execution, Supplier Controls, Product Quality Review, Risk Management, Agency inspections/internal audits, CAPA, and overall Quality Manual requirements. This position will ensure that all product, process or system related quality activities supporting the business from receipt through shipment of final product are in compliance with Corporate, governmental, and local regulations.

　　Responsibilities – Affiliate Quality Manager:

　　· Responsible for the management and oversight of team including hiring, setting performance expectations, providing performance feedback, development of staff and handling of personnel issues. Ensuring adequate resources and appropriate training to effectively support and meet changing business and compliance needs.

　　· Monitor distribution quality activities at the Third Party Logistics provider to ensure compliance with local and AbbVie requirements.

　　· Quality management of supplier qualification program including performance monitoring for key suppliers, QTA management and assessments.

　　· Responsible for implementation of quality management system, defining obligations for wholesaling, procedures and processes and risk management measures. The integration and support of quality regulations at the Romania affiliate: drug, biologics, device and/or combination products driving the design of effective quality systems, procedures and/or processes within cross functional teams to ensure compliance as well as efficiency throughout our quality systems.

　　· Responsible for the management and oversight of staff responsible for support of quality operations at the affiliate level.

　　· Responsible for management and handling of Product quality complaints.

　　· Establish training requirements and maintenance of a diverse and agile cross trained and effective team to ensure business continuity and compliance.

　　· Lead and oversee support activities related to quality events (quality defects, security events, recalls etc) in the affiliates.

　　· 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.

　　· Partner with stakeholders across the enterprise to gain a better understanding of processes external to QA to determine best steps forward.

　　· Oversee coordination and investigation of key quality systems (ie. deviations, non-conformities, CAPA’s and product complaints) ensuring KPIs are met.

　　· 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.

　　· Coordinate the Management Review process at the affiliate

　　· Responsible for establishing and carrying out a quality self-inspection program within the affiliate

　　· Develop and execute quality plans and provide guidance and assistance to the various multi-disciplinary departments and teams with respect to planning and execution

　　· Coordinate change control process to ensure changes do not introduce negative impacts to operation

　　· Provide guidance and oversight for all activities governed by Good Storage and Distribution Practices including monitoring of controlled temperature and cold chain shipments.

　　· Represent affiliate QA in regional, global and cross functional teams, projects and programs, as appropriate.

　　Qualifications (Education/knowledge/experience):

　　· University Degree in Pharmacy

　　· Comprehensive knowledge of national and EU GDP legislation

　　· Excellent written and oral communication skills. Proficiency in English.

　　· Strong computer skills

　　· Knowledge of Quality systems

　　Qualifications (Education/knowledge/experience):

　　· 5+ years’ experience in quality assurance, operations, regulatory or relevant experience. Some supervisory/management experience preferred.

　　· Technical knowledge in as many of the following areas as possible: Quality, Regulatory, Process Sciences, Distribution and Manufacturing Operations

　　· 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.

　　· 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.

　　· Strong decision-making skills; ability to make operational and business decisions with minimal direction.

　　· Negotiation skills, effective collaboration and ability to anticipate needs and requirements.

　　· Strong computer skills

　　· Ability to work in both team setting and independently.

　　Responsibilities – Responsible Person:

　　Ensure that a QMS is implemented and maintained (all GDP related activities are clearly defined and systematically reviewed; responsibilities processes and risk management principles in relation to distribution activities are clearly specified; the quality system is fully documented, and its effectiveness is monitored).

　　Focus on the management of authorized activities and the accuracy and quality of records.

　　Ensure that initial and continuous training programs are implemented and maintained.

　　Responsible for coordinating and promptly performing any recall operations for medicinal products.

　　Ensure that relevant customer complaints are dealt with effectively.

　　Ensure that suppliers and customers are approved.

　　Approve subcontracted activities which may impact GDP further to internal Quality assessment.

　　Ensure that self-inspections are performed at appropriate, regular intervals following a prearranged program and necessary corrective measures are put in place.

　　Keep appropriate records of any delegated duties.

　　Decide on the final disposition of returned, rejected, recalled or falsified products.

　　Approve returns to stock further to internal Quality assessment.

　　Ensure that additional requirements imposed on certain products by National law are adhered to (Distributor reporting in imports, consumptions and exports).

　　Ensure fulfilment of requirements as per National legislation requirements in regard to Wholesaler license

　　Ensure inspection of incoming goods and release to local market.

　　Act as Responsible Person [RP] backup for the Affiliate.

　　AbbVie 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.