JOB DESCRIPTION:

This position is responsible for overseeing Quality Management System (QMS) compliance, regulatory adherence, and commercial quality operations across Pakistan & MENA region with regional Quality Systems and documentation support for EMEA. The role serves as the QMS Management Representative, ensuring alignment with global quality standards, regulatory requirements, and business objectives while driving a strong quality culture and supporting uninterrupted product supply.

Major Responsibilities:

• This role is of Quality & Compliance Leader for Pakistan, and MENA region (including Afghanistan and Iran) markets as well as Quality Systems and documentation support for the EMEA region.

• Accountable for being QMS Management Representative with Responsibility & Authority for the Quality and applicable Regulatory requirements with respect to the Quality Management System; 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.

• Must interface and represent commercial leader in areas of quality decisions, such as escalations, field actions and/or other significant quality issues.

• Oversee Quality Complaints for Abbott products, ensuring timely investigation, resolution, closure & customer follow-ups through the Tech Support Team, and Legal Manufacturers. Proactively reviewing product complaints and address the trends in a timely manner.

• Collaborate with other global entities in fulfilling Field Corrective actions (FCA) resulted from Regulatory Field Safety Notifications.

• Provide relevant quality support for post market surveillance (PMS) activities, ensure timely executions to minimize, any product supply interruption.

• Facilitating Audits (Corporate Quality Audits, Regulatory Audits, ISO-Notified Bodies)

• Ensuring implementation of effective CAPA program across operational site.

• Driving Supplier Qualification Program (Identification, Evaluation through Audits, Monitoring, Maintenance & Re-Qualification).

Review/Approve Changes, Deviations, Investigations, Market Complaints & CAPA.

• Responsible for Budgetary Planning for Quality Operations.

• Evaluate the existing Quality Management System implemented in the country with the Abbott QMS and Business Unit Quality Standards and Procedures and conduct gap analysis, develop a remediation plan and drive it to achieve highest level of compliance.

• Collect information on product quality and when concerning information is obtained, provide timely written report to appropriate management so that necessary and appropriate measures be taken.

• Responsible for administration of and compliance with all major quality system activities including but not limited to document control, record control, training, CAPA, quality incidents, risk management and internal audit.

• Continuously drive for compliance with Abbott quality standards and regulatory requirements.

• 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.

• Responsible for coordination and management of site Quality metric tracking, trending and reporting activities. Assure metrics appropriately characterize the key performance indicators of the quality system.

This position will be the Commercial Quality representative for internal compliance and 3rd party audits / inspections. Coordinate and manage all commercial audits in conjunction with the Commercial office lead.

• Implement new or modify existing processes to maintain compliance with local entity, business unit, division, corporate, voluntary standards and regulatory requirements.

Regional Quality System and Documentation Support:

• Works with the Regional Quality Systems lead to support on the Quality Systems governance in the EMEA region.

• Responsible for supporting the documentation in the region and driving compliance to Good Documentation Practices.

• Responsible for supporting the implementation of Electronic Document and Quality Management systems like Agile and administer/champion the same in the region.

Education/Knowledge & Experience:

• Bachelor’s degree in Pharmacy/Science/Engineering.

• Must have been employed in the Medical Device/Pharmaceutical /IVD/Consumer Healthcare industry for a minimum of 4 years.

• Minimum of 8 years’ experience in Quality Assurance and /or Compliance in a healthcare/regulated industry.

• Ability to effectively communicate in English.

The base pay for this position is

N/A

In specific locations, the pay range may vary from the range posted.

JOB FAMILY:

Operations Quality

DIVISION:

ID Infectious Disease:

LOCATION:

Pakistan > Karachi : Opp: Radio Pakistan Transmission, Hyderabad Road, Landhi

ADDITIONAL LOCATIONS:

WORK SHIFT:

Standard

TRAVEL:

Not specified

MEDICAL SURVEILLANCE:

No

SIGNIFICANT WORK ACTIVITIES:

Not Applicable