Abbott Regional QA Manager, SEA, Hong Kong, Taiwan & Korea in Singapore, Singapore
The incumbent leads the quality efforts of the region in support of the organization’s business objectives. The role is responsible for development, training, implementation and monitoring of quality systems for the ADC SEAHAWK (SE Asia, Hong Kong, Taiwan and Korea) organization, and working with the area commercial organization to ensure full compliance with all laws, regulations, policies and standards. This is achieved through assuring compliance with existing SOPs, and the development and implementation of additional local SOPs, work instructions, checklists etc., where required. This role is responsible for communication of procedural requirements, training on quality systems requirements and procedures for all affected associates, tracking compliance and the coordination of corrective measures where required.
Establish and aggressively drive the Quality Assurance strategy for the SEAHAWK (SE Asia, Hong Kong, Taiwan and Korea) region by taking ownership and aligning with key Global ADC Quality strategies and direction
Ensure consistent application of relevant Quality Assurance policies, programs, and systems by clearly defining specific Abbott and Abbott Diabetes Care SOPs and locally developed procedures that govern critical to success business functions. Recognition that some degree of flexibility to execute activities appropriate to local requirements and market needs is also required
Elevates issues or significant events (product performance issues) to the appropriate facility with relevant facts and details sufficient to allow Subject Matter Experts responsible for the product quality and performance to analyze, investigate and provide feedback and corrective actions appropriate to the issue
When quality gaps are identified, and Corrective and Preventive Actions (CAPA) are required, formulate detailed action plans that integrate identified stakeholders, the actions necessary and the required methods and timelines to successfully correct the problem and prevent the issue from recurring / occurring. Ensure CAPAs identified during audits or other means are successfully resolved prior to committed due dates
Work within region to assist affiliates in audit responses and appropriate corrective actions. Review affiliate audits and respond in a regional manner, assuring any similar deficiencies at other affiliates are also addressed
Establish effective partnerships with the business locations to ensure regional QA needs are identified and successfully met. Work with region to respond to manufacturing site requests (eg quality holds, reworks, complaint product returns)
Organize and develop timely action plans in close coordination with the Area Customer Service Manager ensuring a seamless execution of successful QA strategies for the Asia Pacific region
Develop and maintain a QA status report covering routine department functions and providing updates on key problem resolution initiatives. Examples may include status of safety alerts, quality holds, field actions (recalls), and CAPAs. The status report will include current projected completion dates, and will be updated and published as required / when status changes
Periodic review of SEAHAWK (SE Asia, Hong Kong, Taiwan and Korea) level documents and procedures
The position may require the incumbent to build effective relationships with local regulators, agencies, and trade organizations to influence direction of regulations, requirements, and performance expectations
Work with affiliates to perform local assessments for new partners (eg distributors) and help ensure processes are in place at those partners to maintain product and process quality
Perform Gap Analysis to help drive consistency between affiliates in the region and manufacturing facilities. Evaluate and interpret industry regulations and division policies and develop strategies for ensuring affiliates are compliant
Note: This job description describes the principal and main elements of the job. It is a guide to the nature and main duties of the job as they currently exist, but is not intended as a wholly comprehensive or permanent schedule and is not part of the contract of employment.
Medical device, Pharmaceutical or related industry experience (5 + years) in a QA Role
Regional/Global cross-functional working experiences required
ISO13485:2015 lead auditor certification
Lean 6 Sigma Green belt trained
Strong knowledge of ISO 13485, ISO 9001, 21CFR part820 and ISO14971
Experience in distribution warehouse set-up, qualification and audit
Experience in process and documentation audit
Knowledge and experience in product development, commercialization and manufacturing process in IVD medical device preferred
Ability to communicate effectively in spoken and written English; Chinese (spoken/written) would be an added advantage
Ability to develop problem resolution plans that take into account both project variables and potential intangible events so that critical to success deadlines are routinely achieved
Possess a high degree of responsibility and deep sense of ownership for ensuring the highest level for QA standards. Position will require the ability to rapidly retrieve existing standard operating procedures (SOPs), deploy them as required to facilitate commercial business operations and in some cases develop procedural solutions to appropriately resolve quality and compliance challenges across various business unit functions in the SEAHAWK (SE Asia, Hong Kong, Taiwan and Korea) region
Desired skills/experiences include:
Familiarity with regulations such as ISO 9000/13485, QSR
Experience in working with matrixed organizations
Applicable technical knowledge/experience
Audit evaluations and CAPA resolution planning
Ability to develop procedures and policies that clearly define efficient and effective processes needed to ensure compliance and resolve identified problem.
Experience in leading and participating in cross-functional teams tasked with QA problem resolution
Experience in training curriculum development
Experienced user of Microsoft Office software: Word, Excel, and PowerPoint
Ability to travel 35%of the time
Bachelor's degree minimum, Bio-Engineering, technical or business-related discipline
ACCOUNTABILITY / SCOPE
Prevent problems from occurring to the greatest extent possible by anticipating issues and proactively seeking solutions. Provide guidance and assistance to affiliates to meet business and compliance needs. The guidance, recommendations, feedback, actions and decisions made by the incumbent are critical to assuring compliance with applicable regulatory standards and successfully meeting the business needs and objectives of the division. The impact of such guidance, recommendations and decisions can have a direct effect on the company’s ability to distribute existing products. The incumbent is also responsible for assuring distribution partners have adequate systems in place to store, distribute and/or take customer calls. The incumbent must effectively communicate, prepare and negotiate both internally and externally; failure to do so will have a direct impact on market presence.
ADC Diabetes Care
Singapore > Singapore : DUO Tower
Yes, 25 % of the Time
SIGNIFICANT WORK ACTIVITIES:
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
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