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Quality Systems Manager

3 months ago

Blue Bell, United States Acme-Hardesty Full time

Job Title: Quality Systems Manager

Reports to: Director - Quality and Regulatory

Location: Hybrid (Blue Bell, PA)

OUR COMPANY:

Building upon a heritage of more than 160 years, Jacob Stern & Sons / Acme-Hardesty prides itself in our commitment to lead with compassion, humility, and a sense of humor. This is why our employees provide solutions where others may only see problems. We are a uniquely peculiar company offering refuge to professionals who value respect and dignity rather than the status quo.

Have you ever wondered what it would be like to operate in an environment that rewards those who are passionately curious? It may just be time for you to escape the "daily grind" and join the Acme-Hardesty family. Embrace the change that results from lifelong learning and open collaboration. Take a closer look at Acme-Hardesty.

Acme-Hardesty Co., a division of Jacob Stern & Sons, Inc., is in Blue Bell, Pennsylvania and has evolved today into one of the largest distributors of renewable palm oil derivatives, castor oil and its derivatives, glycerin and preservatives and surfactants. The business serves as the bridge that connects suppliers in Southeast Asia, the Middle East, and South America with customers in North America. Acme-Hardesty brings essential materials, needed by thousands of manufacturers, to create products that benefit millions of consumers.

POSITION OVERVIEW:

The Quality Systems Manager is a key member of the Quality and Regulatory team, responsible for ensuring the highest quality standards of the products and services offered by Acme-Hardesty. Continuous improvement and a commitment to quality are at the heart of this role. The Quality Systems Manager leads and supports various quality processes, including the NCR Process and respective investigations and CAPA requirements. They will work closely with internal and external stakeholders to achieve quality objectives and customer satisfaction. The Quality Systems Manager also contributes to the development and improvement of Quality Policies and Standards in the organization.

RESPONSIBILITES AND ACCOUNTABILITES

  • Hybrid role, on site for at least 3 days a week in the first 3 months, then at least 1 day a week after that.
  • Lead and manage the non-conformance report (NCR) process, ensuring timely identification, investigation, resolution, and closure of quality issues, and holding accountable the relevant personnel and departments involved in the process.
  • Perform root cause analysis and implement corrective and preventive actions (CAPA) as needed, following up on their effectiveness and compliance.
  • Drive continuous improvement efforts by analyzing trends, monitoring key performance indicators, and promoting a culture of quality throughout the organization.
  • Develop and update comprehensive Quality Policies and Standards that capture all aspects of quality management, including procedures, reports, and quality records, in accordance with best practices and industry standards.
  • Collaborate with the Director Quality & Regulatory to develop and maintain a Quality Dashboard that monitors key quality metrics for the company, such as compliance rates, customer complaints, audit findings, and corrective actions, and implements appropriate checks and balances to prevent quality issues.
  • Lead audit processes, both internal and external with third-party vendors, to verify compliance and identify areas for improvement. Focus on managing risk, upholding the integrity of the quality systems and ensuring continuous compliance.
  • Develop and manage the change control process, ensuring that all changes impacting internal and external stakeholders are evaluated, recorded, and communicated in a systematic and compliant manner.
  • Conduct quality audits and inspections on products, processes, third-party logistics, and suppliers to ensure compliance with internal and external standards and regulations.
  • Improve the vendor approval process, ensuring that all suppliers meet the quality standards of Acme-Hardesty. Conduct periodic vendor audits and evaluations and maintain effective communication and relationships with vendors.
  • Collaborate cross-functionally with the Operations and Commercial teams, to provide quality support, technical information, and guidance.
  • Manage and provide oversight on the recall process working with all departments including consulting with the legal counsel and Senior Leadership providing accurate information on the impact of any potential or physical recall.
  • Review customer Quality Agreements and other customer requests and provide input, as required.
  • Manage the Organic Certification program, making sure that the company meets the Standard's requirements.

KNOWLEDGE, ABILITIES, AND SKILLS DESIRED:

  • Bachelors degree in chemistry, food science or related technical discipline required.
  • 8-12 years minimum of experience in quality assurance or quality control in pharmaceutical, nutraceutical and/or food industry. Experience in the chemical distribution industry, an asset.
  • Demonstrated skill in collaborating with external parties in a quality assurance role.
  • Familiarity with FDA Regulations, cGxP, and ICH guidelines.
  • Knowledge and experience with FSMA, FSVP, GFSI Standards, and HACCP.
  • Previous experience with non-conformance management, internal and external audit, and risk management.
  • Proficiency in ISO 9001 and Quality Management Systems.
  • Proficiency in Microsoft Office and other software applications related to quality management and data analysis.
  • Excellent communication, interpersonal, and critical thinking skills.
  • An initiative-taking, collaborative, and customer-oriented attitude.
  • A willingness to learn new skills and take on new challenges.
  • Strong leadership and decision-making skills and the ability to communicate effectively.
  • Must have investigation and conflict resolution skills.