Site Head, Quality Assurance Fulltime

at Klarem Limited


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

License renewals


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

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