Commercial Quality Specialist at Abbott

• This position will ensure that product(s) and/or service(s) meet the established standards of quality including reliability, usability, and performance from a Distribution business standpoint. Works closely with all staff members and promotes Abbott’s Quality Requirements. Contribute and support towards the Quality Management system and aid in maintaining its effectiveness and efficiency for the Africa & Middle East region, and when required for EEMEA region. Works towards ensuring Abbott Global Procedures are integrated into the local quality management system and ensure its implementation. Perform & manage distributor assessment(s) and audit(s) as required. When required support the organization with conducting & managing supplier assessment(s) and audit(s).

WHAT YOU’LL DO

• Ensures the processes needed for the Quality Management System (QMS) are established, implemented and maintained.
• Maintain the Quality System to ensure it meets the local quality management system and Abbott Quality System requirements.
• Supports departments in finding solutions to issues raised and escalate to the Quality Manager for support when required.
• Assists with the set up and coordinate Quality meetings including Management Reviews, the distribution of minutes and follow through of actions for verification and closure.
• Prepare the minutes of the MR meetings for review with the team and Quality Manager.
• Supports the review of the Quality Tracker on a monthly basis and advise outstanding items for closure to departments.
• Ensure that all Quality Communication such as Product Hold are executed and all relevant documentation completed, approved, submitted, and filed to ensure no further distribution of product.
• Identifies any risks noted and capture in the Risk Register and escalates to the Quality Manager
• Ensures the Audit programs devised are adhered to and all audits are performed in accordance with said procedures.
• Provide advice on disposition for Product Deviations receipted at selected Abbott 3rd party warehouse and logistics company.
• Approve all destruction requests for nonconforming products.
• Authorize product returns at selected 3rd party warehouse and logistics company, advise on disposition after inspection and investigation of product handling during storage and transportation.
• Assist in ensuring that all the required Quality Assurance related training is performed, and records filed/retained.
• Perform distributor/supplier Audits/ Pre-assessments for potential distributors identified by commercial within the EEMEA region in support of the distributor on-boarding process.
• Perform distributor Audits/Assessment for already existing distributors in EEMEA region as required.
• Report and track any potential Abbott product theft, diversion, counterfeit, and parallel importing for Africa and Middle East, and when required for EEMEA region.
• Uphold the company’s core values
• 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 management and satisfactory resolution of Quality Incidents (non-conformances) in a timely manner.  Coordinate cross-functionally to ensure implementation of containment, mitigation, remediation and corrective activities as necessary.
• Coordinate with entity management and facilitate Quality Management Review activities, including quarterly quality objective reporting, escalation of issues with QMS impact and closure of open actions from previous meetings.
• 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.
• Other duties as assigned.

THIRD PARTY MANUFACTURER QUALITY ROLE

• Lead, Drive and Support Site Quality Remediation for Repackaging/Manufacturing In-Vitro Diagnostic products and establishing right systems.
• Ensure the external manufacturing sites assess Quality systems effectively through internal audit and Management review and implement corrective/ preventive, improvement actions as appropriate.
• Support manufacturing sites in the investigation, evaluation, and implementation of actions to eliminate root causes of non-conformances.
• Establish and monitor metrics for the measurement of Quality indicators to ensure effectiveness and value to the business.
• Provide disposition for non-compliant products and assures escalation of potential quality or compliance problems to site quality leader.
• Ensure effective risk management processes are implemented to prevent unanticipated failure modes.
• Ensure quality processes are followed across the external network by enforcing Quality Agreements, establishing product specifications, and deploying quality assurance procedures meeting Abbott requirements.  Ensure external partners remains compliant to health authority regulations and other country statutory requirements.
• Ensure defect free and timely product supply to the market. Establish Governance strategies along with Operations, Planning, Regulatory Affairs, and supply chain colleagues, to ensure that external partners continue to remain compliant, agile and flexible to deliver quality products per business needs. Quality events and issues are resolved speedily and through cross functional collaboration as deemed necessary.

REQUIRED QUALIFICATIONS

• Bachelor Degree in Pharmacy/Science/Engineering.
• Must have been employed in the Medical Device/Pharmaceutical /In-Vitro Diagnostics/Healthcare industry in Quality Assurance and/or Quality Management for a minimum of 2 to 3 years.
• Ability to effectively communicate in English. Additional languages will be an advantage.
• Advanced MS office suite skills will be an added advantage.

PREFERRED QUALIFICATIONS

• Strong analytical, communication, decision-making and leadership skills for interaction with external and internal customers and partners.
• Strong ability to negotiate with stakeholders.
• 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.
• Superior attention to accuracy and details.
• Strong leadership skills, including the ability to set goals and provide constructive feedback respectfully to build positive relationships and improve business results.  
• Capable of understanding and overcoming different cultural and language barriers to provide solutions that satisfy corporate, regional, and local objectives.
• Strong English verbal and written communication skills with the ability to convey appropriate information with clarity and effectiveness.
• Strong knowledge of relevant medical device industry regulations for quality systems and compliance.
• Ability to work in a highly matrixed and geographically diverse business environment.
• Ability to work effectively within a team in a fast-paced changing environment.  Multi-tasks, prioritizes and meets deadlines in timely manner.
• Experience in conducting and handling audits and inspections.