Manager Quality Assurance

11 - 15 years experience  •  Biotech/Pharma

Salary depends on experience
Posted on 09/21/17
Columbus, OH
11 - 15 years experience
Biotech/Pharma
Salary depends on experience
Posted on 09/21/17

30053968

JOB DESCRIPTION:

Primary Function / Primary Goals / Objectives:

The Quality Operations Manager is responsible for establishing and executing policies, procedures, and programs that assure Abbott products are developed, manufactured, and marketed with superior quality and conformance with all applicable laws and regulations. Provide ongoing resolution of product quality issues and push for continuous improvement and standardization of best practices across the global nutrition plants. Manage, coordinate, and support critical business quality impact issues. Direct activities in support of division and corporate quality initiatives and provide guidance in the implementation of requirements.

Major Responsibilities:

Responsible for implementing and maintaining the effectiveness of the quality system.

1. Provide risk management of product nonconformities and assure that safe and

effective products are released to the marketplace.

2. Provide batch dispositions and manage nonconforming investigations to

minimize destruction costs without undue regulatory or business risks. Assure proper documentation is performed.

3. Provide divisional leadership to the plants on non-conformance investigations and documentation.

4. Assure active, effective communications between plants and various division

functions regarding quality issues.

5. Lead cross-functional teams during business-critical issues. Assure quality

assurance implications are eliminated and/or addressed.

6. Problem solve and troubleshoot plant issues.

7. Economically manage plant quality costs without undue quality risks by releasing batches expeditiously and participating in cost saving projects.

8. Develop, recommend, and implement major changes in quality policies and

procedures.

9. Act as Abbott's primary contact for management of all product donations to local or international charities.

10. Collect and evaluate quality performance parameters. Recommend and

champion improvements to raise quality performance parameters.

11. Act as a division resource to nutritional plants in preparation for internal and

external audits.

12. Coordinate standardization of compliance audit corrective actions across

nutritional plants.

13. Serve as division liaison with Corporate on quality issues.

Education:

A Bachelor’s degree is required, preferably technical such as Food Science, Chemistry, Microbiology, etc. The incumbent routinely makes or oversees decisions that affect quality and must have a demonstrated capability to understand the diverse technical issues faced by Abbott as related to plant products, processes and packages. Prior work experience in the manufacture of nutritional products is a plus. Excellent analytical and problem solving skills are required.

Background:

Knowledge of applicable regulatory standards and requirements for infant formula and nutritionals.

Incumbent must have experience across a broad range of quality assurance activities including a working knowledge of plant QA functions such as analytical chemistry, incoming materials, quality systems, quality engineering, microbiology, product and process design, and regulatory compliance. Position also requires broad experience with interdepartmental interactions. Must have excellent judgment and decision making abilities. Minimum of 10 years’ relevant experiencerequired including management and QA experience at the division and plant levels.

Accountability / Scope/Budget:

This position reports directly to the Director of QA Food Safety. This role is responsible for the standardization of quality programs across the plants, the recommendation for release or destruct of nonconforming product, the requirement for rework of defective goods, and the promotion, maintenance and expansion of various quality systems. This position requires a high degree of independence and must perform all tasks with minimum supervision from the Director, Quality Assurance Operations/Product Distribution Warehousing.

    

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