**PRIMARY OBJECTIVE:** + Responsible for Quality Management system at the commercial affiliate quality function and to be 100% compliance with Corporate, Divisional and local regulations. **EDUCATION/QUALIFICATIONS/EXPERIENCE:** + Minimum of bachelor’s degree in sciences, Pharmacy, or equivalent education/work experience will be considered. + Knowledge of local Medical Device regulations will be an advantage + Conversant local language as well both written and spoken English **KEY COMPETENCIES SKILLS** **:** + Computer proficiency in Word, Excel and PowerPoint. + Strong interpersonal skills, with the ability to build and maintain relationships. + Effective time management + Well organized, able to set and reset priorities + Strong oral and written communication skills. + Detail and deadline oriented. + Ability to work in a fast-paced multi-tasked environment + Demonstrates a highly positive attitude concerning risk, change and unexpected challenges. + Tendency to be friendly, cooperative, agreeable. To be a team person. Promotes the benefits of teamwork and cooperation. Is usually willing to share resources and information. **KEY RESPONSIBILITIES:** + Support in developing, implementing, assuring, and monitoring the Quality and Regulatory Compliance strategies of the company + End-to-end responsibility on Complaint Handling/ post market surveillance, and coordinate with cross cross-functional team for product quality complaints to ensure the complaint reporting is on time + Coordinate with the Health Authority to report Adverse Event and Field action information and updates to ensure compliance with the health authority regulation + To ensure all impacted Stop Shipment products are in the Quarantine location and follow up for retrieval and compilation of Field Safety Corrective Actions records as per instructions from Regional or Divisional QA. + Management of LMS: Assignment of QMS training to employees on quality-related documents and policies, and monitoring of training completion timeliness, function as LMS coordinator for the SEA affiliate. + End-to-end Suppliers and distributors ' activities at the site through appropriate assessment, qualification, and monitoring of suppliers in compliance with company requirements. Monitoring of suppliers in compliance with the global procedures and local regulations. + To ensure that the advertisement & promotional, and HCP material process comply as per local regulation and Abbott requirements + Interacts periodically with Commercial, Regulatory Affairs, Supply Chain, Technical Service, Education, and other functions on all quality-related matters. + Manages the document control for QMS procedures and archival of quality records + Manage the change control process to meet amendments to local procedures. + Support and prepare affiliate for Internal & External Quality & Compliance Audits **OTHER FUNCTIONS AND RESPONSIBILITIES:** + Perform various administrative functions as required. + Any other activities as assigned from time to time by the Line Manager **ABBOTT COMPETENCIES:** **Build** Key Actions: + Creates a sustainable infrastructure and environment that enables growth. + Maintains leadership presence and emotional control in difficult situations. + Provides accurate, frequent, and constructive feedback to subordinates, peers, and leaders. + Makes difficult people, financial, and business decisions in a timely manner. **Set Vision and Strategy** Key Actions: + Identifies and acts upon trends that can impact the business. + Creates and communicates a motivating, compelling vision of the future that supports employee engagement. + Translates strategies into actionable goals and plans, and then communicates them to ensure alignment of effort and purpose **Deliver Results** Key Actions: + Displays continuous energy, intensity, and persistence to drive the organization forward. + Delivers what is promised; holds self and others accountable for results, commitments, and behaviors. + Takes appropriate accountability for failure; does not blame others. + Takes action in a timely manner, with urgency or caution as appropriate, but always in a planful way. + Balances short- and long-term priorities and maximizes the opportunities for both. + Addresses organizational or cultural barriers that could prevent success. **Anticipate** Key Actions: + Develops scenario and contingency plans that ensure achievement of results under changing conditions and situations. + Takes initiative to implement change before others. + Actively gathers customer inputs in order to anticipate and fulfill their needs and requirements. + Manages internal/external stakeholders to identify and address issues. + Understands the situation or audience and adjusts approach to achieve desired outcomes. **Innovation** Key Actions: + Creates an environment of experimentation and uses failure as an opportunity to learn and take alternate action. + Challenges current thinking generates new ideas and expects others to do the same. + Integrates information from multiple sources to generate unique insights or new solutions that distinguish Abbott from the competition. + Leverage’s diversity of people and thinking to create a competitive advantage. + Collaborates across boundaries to create cross business opportunities. An Equal Opportunity Employer Abbot welcomes and encourages diversity in our workforce. We provide reasonable accommodation to qualified individuals with disabilities. To request accommodation, please call 224-667-4913 or email corpjat@abbott.com