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Commercial Quality Excellence Lead
2 weeks ago
Our rapid diagnostics solutions are helping address some of the world's greatest healthcare challenges.
Primary Overview:
- This role provides support to the Asia Pacific region on the Commercial Quality Excellence responsibilities. The role ensures that all the strategic global and regional commercial quality initiatives/projects are successfully rolledout and progressed in the APAC region.
- The incumbent in this role also provides operational support to all the markets in the region by working with Director of Global Commercial Quality.
Responsibilities:
- Carries out duties in compliance with established business policies and procedures.
- Demonstrates commitment to the development, implementation, and effectiveness of applicable Quality Processes as per ISO, and other regulatory agencies.
- Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company's policies and practices.
- Responsible for developing, implementing, and maintaining project management activities.
- Participate in strategic projects' review meetings and manage the project governance in the region.
- Drive implementation of strategic initiatives required for the commercial quality team (annual goal creation and subsequent project rollout, field corrective action communication and rollout, etc.) for the APAC region.
- Manage broad and crossfunctional quality projects related to the Commercial Quality.
- Responsible for working with each of the APAC markets to provide operational quality support in consultation with the Director of Global Commercial Quality.
- Support the Audit readiness programs in the APAC region and work closely with the affiliates to support the preparation of key audits and inspections((Corporate Quality Audits, Regulatory Audits, ISO-Notified Bodies)
- Responsible for supporting the APAC affiliates on the Quality and Regulatory requirements; ensuring compliance to Abbott Global Quality/Regulatory Framework, Divisional Policies/ Procedures.
- Responsible for proactively creating Quality Culture by training the Commercial teams.
- Engage as required for the Quality Complaints for Abbott products, ensuring timely investigation, resolution, closure & customer followups through the Legal Manufacturers and Tech Support Team. Proactively reviewing product complaints and address the trends in a timely manner.
- Act as the point of contact/coordination in APAC with other global entities in fulfilling Field Corrective actions (FCA) resulted from Regulatory Field Safety Notifications.
- Supporting Supplier Management Program in the region (Identification, Evaluation through Audits, Monitoring, Maintenance & Re-Qualification).
- Supporting Budgetary Planning for Quality Operations, as needed.
- Support quality remediation programs.
- Continuously drive for compliance with Abbott quality standards and regulatory requirements.
- Other duties as assigned.
Requirements:
- Bachelor's Degree in Pharmacy/Science/Engineering.
- Minimum 35 years of related experience in Medical Device/Pharmaceutical /In-Vitro Diagnostics/Healthcare industry
- Strong analytical, communication, decisionmaking 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 fastpaced changing environment. Multitasks, prioritizes and meets deadlines in timely manner.
- Experience in conducting and handling audits and inspections.
Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life.
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