The VP of Quality will have responsibilities for the QA & QC programs at the high volume NJ facility. Responsibilities include ensuring compliance with current Good Manufacturing Practices (cGMP) as they pertain to the local regulation and exporting countries regulation as applicable (FDA, MHRA, EMA, Health Canada). The VP of Quality will maintain Internal and external relationships relating to quality.
- Management of Quality Assurance, Quality Control and Laboratory Operations (Analytical Metohd Development, QC Analytical, Stability and Microbiology)
- Documentation control (master batch record, specification & method)
- Batch record review and product disposition
- Investigations, complaints, deviations, CAPAs, APRs
- Production and Pharmaceutical Development support
- APRs, GMP training and SOP review
- Validation /qualification documentation review & approval
- QA Operations – inspection, sampling, and review of incoming materials, perform AQL inspections, support and drive compliance throughout the site
- Develop, maintain, and enhance training programs and systems
- Driving key compliance initiatives such as Data Integrity, Training Program Enhancements, Quality Documentation System Enhancements, other identified initiatives.
- Departmental budget development and compliance
- Quality Compliance management:
- All audits, internal, external – regulatory, client and vendor
- Vendor management program
- QA Agreements with clients & contractors
- License renewals
- Plan and monitor the Quality Assurance department’s annual budget on a monthly basis, according to Company’s guidelines and develop any action plans necessary to ensure achievement.
- Make decisions pertaining to the workforce according to the company’s current policies and guidelines.
- Implement an efficient organizational structure.
- Support continuous improvement and/or cost reduction project
- Manage, develop and motivate the Quality Team:
- Determine the professional development needs among its managers and the quality group and elaborate action plans in collaboration with the Human Resources Department.
- Develop and Maintain Key Performance Indicators for the Quality Operation and discuss performance/opportunities
- Coach employee & share expertise in quality aspect, decision making and problem solving.
- Ensure a strong relationship with customers
- Develop a client based attitude in the Quality organization
Experience & Skills Required
- 10+ years of experience in a pharmaceutical environment, in Quality Operations, with FDA Audit experience (prior contract manufacturing experience is highly desireable)
- Extensive knowledge of US and EU current Good Manufacturing Practices
- The successful applicant should have a deep understanding of Quality Assurance, and be highly knowledgeable in Quality Control Laboratory Operations and Microbiologic requirements.
- Excellent communication skills (English, oral and written)
- Prior professional leadership experience in a contract manufacturing environment is highly desireable.
- Excellent knowledge of validation requirements