QA Manager

at  Abbott Laboratories

PRIMARY FUNCTION:

The incumbent leads the quality efforts of Australia and New Zealand in support of the organization’s business objectives. The role is responsible for development, training, implementation, and monitoring of quality systems for ADC Australia and New Zealand organization and working with APAC area as well as division commercial QA 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.

GENERAL RESPONSIBILITY:

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.

MINIMUM BACKGROUND / EXPERIENCE REQUIRED

• Medical device, Pharmaceutical or related industry experience (10+ years) in a QA Role.
• Global cross-functional working experiences required.
• Strong knowledge for ISO 13485, ISO 9001, MDSAP and 21CFR part820
• Experience in distribution warehouse set-up, qualification, and audit.
• Experience in process and documentation audit.
• People management experience is preferred.
• Knowledge and experience in product development, commercialization, and manufacturing process in IVD medical device preferred.
• Ability to communicate fluently/effectively in spoken and written English.
• Ability to develop problem resolution plans that consider both project variables and potential intangible events so that critical to success deadlines are routinely achieved.
• Must 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.
• Desired skills/experiences include:
• Familiarity with regulations such as ISO 9000/13485, QSR.
• Change management.
• Experience in working with matrixed organizations.
• Program/project management.
• Cross-functional/cross-divisional experiences.
• 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.

MINIMUM EDUCATION REQUIRED

Bachelor’s degree or equivalent

MAIN / MAJOR RESPONSIBILITIES

• Establish and aggressively drive the Quality Assurance strategy for Australia and New Zealand 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.
• Elevate issues or significant events (product performance issues) to the appropriate facility with relevant facts and details enough 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 Australia and New Zealand to lead in audit responses and appropriate corrective actions. Review internal and external audits and respond in to assure any similar deficiencies are also addressed.
• Sustain ISO9001 certification for Australia.
• Establish effective partnerships within the business locations to ensure QA needs are identified and successfully met. Respond to manufacturing site requests (e.g., quality holds, reworks, complaint product returns).
• Organize and develop timely action plans in close coordination with the Regional Customer Service Manager ensuring a seamless execution of successful QA strategies for Australia and New Zealand.
• 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 Australia and New Zealand documents and procedures.
• The position will require the incumbent to build effective relationships with local regulators, agencies, and trade organizations to influence direction of regulations, requirements, and performance expectations.
• Perform local assessments for new partners (e.g., distributors) and help ensure processes are in place at those partners to maintain product and process quality.
• Perform internal audits for Australia and New Zealand as required.
• Perform Gap Analysis to help drive consistency between commercial organization and manufacturing facilities. Evaluate and interpret industry regulations and division policies and develop strategies for ensuring Australia and New Zealand are compliant.
• Responsible as Quality representative for Australia and New Zealand.

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.