Quality Manager( Abbott Laboratories )

Компания "Abbott Laboratories"

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 115,000 colleagues serve people in more than 160 countries.

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You will have access to:

• Career development with an international company where you can grow the career you dream of.
• A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
• A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.

The key to successful treatment and full recovery is often fast, accurate diagnosis. Abbott’s life-changing tests and diagnostic tools provide insights that enable smarter, faster decisions and transform the way the world is managing health.

We are now looking for Quality Manager.

The Opportunity

Quality Manager will ensure Quality System awareness and compliance of new and revised quality documents and regulations that affect the assigned area of responsibility. He/she will also support the business in the affiliate.

What You’ll Do

• Plan and conduct internal audits to verify the effectiveness of the management system.
• Prepare/ coordinate external audits.
• Perform supplier audits as required.
• Support/provide training to the organization about the CRDx Quality System.
• Ensure QS record keeping, document control, Warehousing, QH, Supplier/ Distributor evaluation/ monitoring, CAPA management follow up and ensure timely closure.
• Coordinate Field Communications at the Region.
• Ensure availability of org charts (including LSME if required) and job descriptions.
• Assess risk related to processes.
• Timely escalate regional concerns to Area Management Review and MIMS MR.
• Support Global Commercial Affiliates QA improvement projects.
• Maintain/challenge current certifications. Propose new certificates if required.
• Coordinate communication between commercial organization and Regulatory to support responses in contracts and public tenders (e.g. QARA, EHS, Data Privacy requirements).
• Be the expert on a QS process and support the rest of team as process SME: either as lead, backup or team member.
• Review Abbott policies & procedures, and updаtеQuality documentation accordingly.
• Manage any audit input by initiating changes to affected processes following MIMS change control procedures.
• Identify and coordinate improvement initiatives within the entire QS.
• Participate in Quality System improvements and implementation projects
• Actively seek internal/external customer feedback and respond to issues.
• Manage the QA budget, always considering cost improvement opportunities.

Key Requirements

• Scientific background (i.e. Lab Technician, Biology, Chemistry, Pharmacy, M.D.) is preferred. Other education (i.e. business, engineer) is acceptable if experience of 3 or more years in similar manager position.
• Quality Assurance in a commercial affiliate at the IVD/ MD/ pharmaceutical industry is preferred, either as manager or as specialist, for at least 3 years.
• At least 7 years´ experience.
• Product and market environment knowledge preferred.
• Management skills and leadership competencies.
• English negotiation skills.
• Experience to work in international environment.

The stated job description, as well as the list of job requirements, is not complete.

This position opens for staff replacement.

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