Reporting to the General Manager, the Site Quality Head is in charge of Quality Assurance and Quality Compliance, ensuring compliance with current Good Manufacturing Practices (cGMP) as they pertain to the local regulation and exporting countries regulation as applicable(such as FDA, MHRA, EMA, SFDA).
Overall responsibility for quality operations and initiatives, including:
Quality Assurance management:
In collaboration with the Quality Assurance team, responsible for:
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 at Klarem
Quality Compliance management:
In collaboration with the Quality Compliance team
All audits, internal, external – regulatory, client and vendor
Vendor management program
QA Agreements with clients & contractors
Plan and monitor the Quality Assurance department’s annual budget on a monthly basis, according to Klarm’s guidelines and develop any action plans necessary to ensure achievement.
Manage, develop and motivate the Quality Team:
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
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 Klarem’s customers
Develop a client biased attitude in the Quality organization
Other duties as assigned
Bachelor of Science (B. Sc.), Masters preferred, related to the pharmaceutical industry
15 years of experience in a pharmaceutical environment, in Quality Operations
Extensive knowledge of current Good Manufacturing Practices
Expertise in Quality Control Laboratory Operations
Mastery of English- oral and written
Microbiological services experience either through direct or line management
Experience with a CDMO would be preferable
Excellent knowledge of validation requirements