Job Description

SUMMARY

Our client is one of the most respected manufacturers of encapsulated dietary supplements and nutritional products in the United States. They operate in a GMP-compliant FDA inspected facility and have over 26 years of product development expertise and experience. They are revolutionizing contract manufacturing of dietary supplements with relentless precision and cutting edge technology. Own The Arena has been retained to help find a Director of Plant Quality to join the team, based in Portland, OR Metro, specifically Clackamas, OR.

THE OPPORTUNITY

In this critical role you’ll will lead Clackamas, OR plant quality management within a cGMP facility. You will work to improve customer satisfaction and continually improve the plant’s product quality and product safety related performance. You will be responsible for defining and leading compliance requirements to meet both business and strategic needs. You’ll collaborate with both corporate and company leadership, customer service, production staff and suppliers for any quality related events within the organization.

You will supervise the day-to-day activities of the quality team (QA and QC) at the Clackamas plant, implement product quality and product safety improvement strategies at the plant level, establish and publish appropriate product quality and product safety performance metrics and analyze and improve performance. You will help ensure the plant complies with corporate policies and procedures and all regulatory requirements as they pertain to product quality and product safety.

The position reports to the IFF Global Quality Director for Finished Format and indirectly to the Clackamas Plant Manager.

ESSENTIAL FUNCTIONS

• Define, implement, and lead the Clackamas plant’s quality and product safety management systems including both quality assurance and quality control.
• Manage the development, implementation, and maintenance of an integrated quality management system to maintain compliance with regulatory requirements and with the plant’s applicable third-party certification standards including NSF 455-2 and ISO 17025, as defined by the plant and/or the business’s go-to-market strategy.
• Author, review and approve site policies, procedures, work instructions and standards to ensure consistency across the organization and ensure compliance to all applicate regulations and standards.
• Work with the plant leadership team to ensure that the plant’s established quality and product safety guidelines, policies and procedures are followed effectively. Provide training and direction and overall leadership to drive the quality process and compliance.
• Ensure audit readiness for quality and product safety related audits including: Internal audits conducted to ensure compliance with applicable regulations, GMP’s, and internal programs.
• External quality-related audits of the Clackamas site conducted by outside agencies, regulatory authorities, or by specific customers.
• Vendor audits in cooperation with the corporate / regional quality and product safety organization, as needed.
• Accountable for site quality objectives. Collect and analyze sources of quality data for need to initiate corrective or preventive action.
• Responsible for the review and assessment of management of change (MOC), complaints, non-conformances, deviations and other quality data for need to perform root cause investigations. 
• Effectively develop and mentor the plant quality team to ensure succession planning and to support the future growth of the business.
• Ensure adherence to IFF’s Quality, Sustainability and Environmental Policies and Procedures.
• Comply with all company policies, including maintaining a drug-free workplace.
• Support an environment of continuous improvement within the assigned area of responsibility.

KNOWLEDGE, SKILLS AND ABILITIES

• Must at the minimum possess a U.S. bachelor’s degree (4-year University degree) in food science, microbiology, biochemistry, engineering, or a related field. Masters degree is a plus.
• Must have a minimum of 10 years of work experience in dietary supplement manufacturing, food manufacturing, dietary ingredient manufacturing, or other similar regulated field, preferably with experience in quality control, quality assurance or regulatory affairs.
• Must have strong leadership skills with the ability to lead people in both direct and indirect management relationships.
• Must have good interpersonal skills, have a collaborative mindset, and possess the ability to work in a team environment.

WORKING CONDITIONS

This position works in a manufacturing environment. This is an onsite opportunity based in Clackamas, OR. Individuals must reside in the Portland, OR area or be willing to relocate. Our client is an equal opportunity employer committed to fostering a diverse and inclusive workplace.

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