Abbott

Site Quality Director

Posted Yesterday

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Oslo

Senior level

Healthtech

The Role

The Site Quality Director at Abbott oversees quality compliance and regulatory standards for the Oslo site, ensuring effective quality systems aligned with FDA and ISO requirements. This role involves leading quality personnel, managing audits, and maintaining supplier quality programs while fostering communication on compliance across teams.

Summary Generated by Built In

JOB DESCRIPTION:

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 109,000 colleagues serve people in more than 160 countries.

Abbott Diagnostics Technologies AS (ATN) is looking for an

Site Quality Director

To be based in Oslo, Norway.

Abbott Diagnostics Technologies AS (ATN) is part of Abbott Diagnostics, bringing together teams of experts and industry leading technologies to support diagnostic testing which provides important information for treatment and management of diseases and other conditions.

The position of Site Quality Director is within our Cardiometabolic Unit located in Oslo, Norway. This role provides strategic direction and tactical assistance to ATN on matters related to regulatory compliance and quality issues and is responsible for maintaining an effective and compliant Quality System, suitable for the activities performed by ATN.

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, FDA, 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.
Responsibility to understand and maintain awareness of the quality consequences which may occur from the improper performance of their specific job.
Provides leadership and direction to the Oslo site organization in the development, implementation, maintenance and improvement of a Quality System appropriate for the functions performed, ensures that the importance of an effective and compliant Quality System to communicated to all employees, and assesses and reports on Quality System effectiveness and any need for improvement to site management
Serves as the Management Representative responsible for ensuring that a compliant Quality System per FDA and ISO requirements is implemented, maintained, and improved throughout the organization
Serves as the Person Responsible for Regulatory Compliance under the EU/EEA regulation (IVDR)
Member of site management team
Acts as the point of contact providing regulatory compliance and quality guidance and expertise related to business
Interfaces with regulatory bodies with a view to enhancing the profile and the perception of the site as an ethical, responsible and compliant corporation by such regulators
Represents the site in the execution and follow up of compliance audits
Ensures processes utilized in the production and management of IVDs are fully qualified, characterized and maintained
Oversees the quality risk management system
Oversees the post market surveillance system
Maintains an effective supplier management program
Oversees the internal audit program
Collaborates with other sites and groups within the division to create and implement shared processes and metrics, where appropriate
Manages all Quality personnel and supports their development through interaction and training to ensure informed and compliant business interactions and processes
Responsible for the Management Review Meeting process, developing, maintaining and reporting quality metrics to site management, monitoring the success of service provided, and personifying the spirit of the Quality Policy
Responsible for overseeing quality training of staff relative to applicable Quality System requirements and applicable quality regulations
Manage performance of staff towards department and company goals, including feedback on performance, appraisals, recommendations for merit increases or necessary disciplinary actions, communication to employees on performance, training etc.
Responsibility for specific tasks will be reflected in the employee’s training plan

Authority:

The framework for the position is given by the regulatory requirements applicable to the IVD industry as defined in Quality Manual, Procedures and Work instructions and strategies set by the Business Unit and Division
The job holder prioritizes his / her daily work independently within given time limits and deadlines. If necessary, clarify priorities with Business Unit Quality lead
The position holder has decision-making authority for the responsibilities given in paragraph 1 and approved project plans

YOUR PROFILE

Education: Bachelor’s degree in natural science or equivalent technical discipline, master’s degree preferred
Minimum 5 years’ experience in directly related field
Quality and IVD regulation training
Advanced knowledge of FDA Quality System Requirements, ISO 13485 standard and other applicable regulations for IVD Medical Devices
Highly proficient in deploying ISO 13485 and FDA 21CFR part 820 aligned systems/processes
Knowledge and proficiency in quality management techniques
Strong written and verbal communication skills, both in Norwegian and English, including ability to articulate complex regulatory arguments with clarity
Must have a strategic perspective and be capable of synthesizing information and prior experience from multiple sources to build efficient and successful regulatory compliance and quality strategies for the organization
Experience in leading and implementing change initiatives and active stakeholder management
Experience in working with culturally diverse groups of people, able to communicate effectively at all levels of the business, and with both technical and non-technical people, adapting approach to suit the audience
Experience in establishing and leading teams, and coaching and developing team members to maximize individual and team effectiveness