Overview
VRT (Variability Reduction Team) Quality Analyst Jobs in Chicago, IL at Ford Motor Company
The Vice President of Quality and Regulatory oversees all aspects of quality assurance, quality control, regulatory affairs, and R&D/stability to ensure compliance with FDA regulations and industry standards. This leadership role is responsible for developing, implementing, and maintaining robust quality systems, fostering a culture of continuous improvement, and ensuring that products meet all safety, efficacy, and quality standards.
Essential Duties and Responsibilities include the following:
Develop and execute the company’s quality and regulatory strategies to support business growth and compliance objectives.
Oversee the QA, QC, and R&D/Stability teams to ensure adherence to FDA regulations (21 CFR Part 210/211/820, etc.), cGMP, and other relevant standards.
Lead the design, implementation, and continuous improvement of quality management systems (QMS).
Maintain up-to-date knowledge of regulatory requirements and ensure company compliance with current FDA guidelines and international standards.
Prepare and manage regulatory submissions, including INDs, BLAs, and DMFs.
Liaise with regulatory agencies during inspections, audits, and investigations.
Establish and monitor key quality metrics and take corrective and preventive actions as needed.
Collaborate with R&D to develop stable formulations and ensure readiness for regulatory approval.
Foster a quality-first culture across departments.
Manage and develop the QA, QC, and R&D teams, ensuring adequate training and professional development.
Assist in risk management and mitigation strategies for product development and manufacturing processes.
Education and/or Experience
Bachelor’s degree in Life Sciences, Engineering, or a related field; advanced degree (e.g., Master’s, PhD, MBA) preferred.
Minimum of 10 years of experience in quality and/or regulatory within the chemical manufacturing industry, with a focus on personal care and animal care products preferred.
Proven track record of managing successful quality and/or regulatory teams.
Strong understanding of regulatory standards and guidelines associated with chemical manufacturing and product safety.
Strong understanding of quality systems, validation, and process development.
Additional Skills
Strong interpersonal and communication skills to engage effectively with team members and other departments.
Proven leadership abilities, with a focus on team motivation and engagement.
Excellent time management skills and the ability to prioritize tasks in a fast-paced environment.
Analytical and problem-solving skills to proactively address production challenges.
Attention to detail, ensuring compliance with all safety and quality standards.
Flexibility to work assigned shifts, including evenings and weekends if necessary.
Commitment to fostering a culture of safety and maintaining high levels of compliance with company policies and procedures.
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Title: VRT (Variability Reduction Team) Quality Analyst
Company: Ford Motor Company
Location: Chicago, IL