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Job Description

Day to Day:

Insight Global is seeking a Multi-Site Plant Quality Manager to work in Beaverton, MI! The Multi-Site Plant Quality Manager is responsible for ensuring the effective implementation of the Quality Management System in alignment with regulatory and corporate requirements across multiple manufacturing locations. This role will proactively identify and report areas of concern to management while driving compliance with ISO 13485, customer specifications, and corporate quality procedures. This role will be the point of contact for customer quality escalations.

The Muti-Site Plant Quality manager will develop and implement consistent quality systems across all sites to enhance operational efficiency and support strategic initiatives as guided by the BPS Quality Director. This role will lead, train, and develop quality teams at multiple locations, fostering a culture of continuous improvement.

Key Responsibilities:

• Implement and oversee a Quality Management System compliant with corporate policies, ISO:13485, and industry guidance.

• Manage Quality department personnel and develop consistent quality systems across two sites: Beaverton, MI and Williamsburg, MI.

• Support the BPS Director of Quality in policy development, strategic initiatives, and maintaining the Global QMS e-tool (ETQ).

• Promote a safe working environment, ensure compliance with EMS requirements, and manage document control, ECO process, supplier quality, and internal audits.

• Handle customer management, including audits, quality agreements, ISO certification, and continuous improvement.

Salary: $140,000-$160,000

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to [email protected] learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.

Skills and Requirements

• Bachelor's Degree in Life Sciences related field (Chemistry, Biology, Microbiology), Engineering, Quality, Operations Management or other applicable degree with Life Sciences experience

• 10+ years of experience in a Quality function in Quality System design, development, implementation role or progressive roles held in an operations site

• 5+ years of experience in biopharmaceutical quality management systems

• 5+ years of direct supervisory experience.

• Strong knowledge of ISO 13485

• cGMP requirements and relevant industry standard practices

• Ability to interpret these regulations to ensure proper implementation in the plant systems • ISO 13485 certification

• 8+ years of experience in a regulated industry with preferred emphasis in life sciences (e.g., pharma, biopharm, or medical device)

• QMS and product quality experience

• Environmental monitoring experience – managing the team that oversees the space