Abbott Diagnostics is looking for a
Senior Regional Commercial Quality Manager (Eastern Europe, Turkey, Russia & CIS). Abbott Rapid Diagnostics (ARDx), is part of Abbott’s Diagnostics family of businesses, bringing together exceptional teams of experts and industry leading technologies to support diagnostic testing which provides important information for treatment and management of diseases and other conditions.
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.
- Responsible for proactively creating Quality Culture w.r.t People, Process, Products & Services to meet customer needs.
- 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.
- Engage as required for the Quality Complaints for Abbott products, ensuring timely investigation, resolution, closure & customer follow-ups through the Legal Manufacturers and Tech Support Team. 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 the highest level of compliance.
- Responsible for the Quality Control program for imported products that are distributed in the market: a) Has final decision making responsibility for product release. b) Has final decision making and reporting responsibilities for field corrective actions. c) 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.
- 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 InVitro 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.
Basic qualifications / education:
- Bachelor Degree in Pharmacy/Science/Engineering.
- Must have been employed in the Medical Device/Pharmaceutical /In-Vitro.
- Diagnostics/Healthcare industry for a minimum of 6 years.
- Minimum of 13 years of experience in Quality Assurance and /or Compliance in a regulated industry.
- Minimum of 3 years supervisory / managerial experience.
- Ability to effectively communicate in English.
Competencies:
- 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 in order 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.
- Multitasks, prioritizes and meets deadlines in timely manner.
- Experience in conducting and handling audits and inspections.
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