Director, Quality Assurance & Plant Excellence
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Job Location:
Bowling Green, OH - USA
Monthly Salary:
$ 150000 - 200000
Posted on:
22 hours ago
Vacancies:
1 Vacancy
Job Summary
Director Quality Assurance & Plant Excellence
Responsibilities
I. Quality Strategy and Management Systems
Strategic Planning & Leadership: Define and execute the sites short-term and long-term strategy for Quality Hygiene and Compliance Systems aligning them with global business objectives.
Integrated Management System: Lead the implementation maintenance and continuous improvement of the integrated ISO Management System (e.g. ISO 9001 and other relevant industry standards).
System Design: Design develop and continuously improve facility standards Quality methods practices tools and Standard Operating Procedures (SOPs) to ensure operational rigor and consistency.
Risk Management: Implement and oversee robust quality risk management and mitigation strategies (e.g. FMEA HACCP principles) to ensure product reliability and safety.
II. Plant Excellence & Continuous Improvement (CI)
CI Leadership: Champion a culture of continuous improvement leading CI initiatives to enhance process capability reduce defects and minimize the Cost of Poor Quality (COPQ).
Defect Reduction: Utilize process mapping Root Cause Analysis (RCA) and Corrective and Preventive Actions (CAPA) to systematically resolve recurring quality and hygiene issues.
Cross-Functional Partnership: Collaborate closely with Operations Engineering R&D and Supply Chain to seamlessly integrate quality requirements into new product initiatives (APQP) process modifications and material sourcing.
Technical Support: Provide expert technical assistance to support departments ensuring quality and hygiene principles are embedded from raw material receipt through finished product shipment.
III. Audits Compliance and Hygiene
Audit Command: Serve as the primary site authority and contact for all external quality and compliance audits (customer 3rd party regulatory agencies).
Audit Readiness: Develop train and maintain internal capability to successfully host external audits ensuring a seamless process with zero business disruption.
Internal Auditing: Develop and lead a site internal audit program that actively monitors system effectiveness and drives proactive improvement actions.
Hygiene & Sanitation: Ensure Hygiene/Sanitation capability is rigorously developed implemented and maintained throughout the plant working closely with the plant hygienist/sanitation team to mitigate cross-contamination risks and ensure environmental monitoring program effectiveness.
IV. Team Leadership & Culture
Talent Development: Lead mentor and develop the site Quality and Hygiene teams fostering a high-performance culture focused on preventative quality and compliance ownership.
Zero Defect Culture: Drive the adoption of Zero Defect thinking and principles across all levels of the site organization.
Qualifications
Education: Bachelors degree in a related field (e.g. Engineering Chemistry Biology Industrial Management).
Experience: 10 years of progressive professional experience is required including at least 5 years in a managerial or site leadership role over Quality and/or Hygiene/Sanitation in a high-volume manufacturing environment.
Technical Expertise: Deep working knowledge of Quality fundamentals principles core tools and experience with contemporary Quality Management Systems (QMS).
Process Improvement Acumen: Demonstrated mastery in driving continuous improvement using methodologies such as Process Mapping Six Sigma or Lean Manufacturing principles.
Audit & Compliance Experience: Extensive experience successfully leading and managing major customer and regulatory audits (e.g. FDA GMP ISO or similar industry-specific standards).
Soft Skills: Exceptional leadership presence interpersonal skills and professional communication skills (written verbal and presentation) necessary to influence across all organizational levels.
Preferred: Relevant Quality certifications (e.g. ASQ Certified Manager of Quality/Organizational Excellence Six Sigma Black Belt PCQI).
Travel: Willingness to travel occasionally.
Required Experience:
Director
Key Skills
- Quality Assurance
- FDA Regulations
- ISO 9001
- Root cause Analysis
- Biotechnology
- Clinical Trials
- Quality Systems
- Food Processing
- Quality Control
- Quality Management
- cGMP
- HACCP
