Job Responsibilities

• Accountable for being Management representative with Responsibility & Authority for the Quality and Regulatory requirements; ensuring compliance to Abbott Global Quality/Regulatory Framework, Divisional Policies/ Procedures.
• Maintain QMS in the market and continually evaluate and monitor the quality system for suitability and adequacy for the commercial business.
• Responsible for proactively creating Quality Culture w.r.t People, Process, Products & Services to meet customer needs.
• Responsible for management and satisfactory resolution of product issues in a timely manner. 
• Coordinate cross-functionally to ensure implementation of containment, mitigation, remediation and corrective activities as necessary.
• Facilitating Audits (Corporate Quality Audits, Regulatory Audits, ISO-Notified Bodies)
• Driving Supplier Qualification Program (Identification, Evaluation through Audits, Monitoring, Maintenance & Re-Qualification).

Qualifications

• Minimum of  8 years in Quality Assurance and /or Compliance in a regulated industry/Healthcare/Consumer Healthcare organization. At the same time, must have been employed in the Medical Device/Pharmaceutical /IVD/Consumer Healthcare industry for a minimum of 4 years.
• Experience in conducting and handling audits and inspections.
• Strong knowledge of relevant medical device industry regulations for quality systems and compliance.
• Strong analytical, communication, decision-making and leadership skills for interaction with external and internal customers and partners.
• Strong ability to negotiate with stakeholders.
• Superior attention to accuracy and details.
• Able to manage multiple priorities and pull information together from multiple business units to ensure concise consolidated business picture is communicated to the commercial businesses.
• Ability to work effectively within a team in a fast-paced changing environment. Multi-tasks, prioritizes and meets deadlines in timely manner.
• Strong English verbal and written communication skills with the ability to convey appropriate information with clarity and effectiveness.

Education

• Bachelor Degree or above in Pharmacy/Science/Engineering.