The Senior Manager,Quality is responsible for leading and managing the quality assurance and control functions within Chanelle Pharma Laboratories, Jordan. This includes establishing and maintaining quality systems, ensuring compliance with regulatory requirements, and driving continuous improvement initiatives.
In this role, you will report functionally to the Head of Global Quality and Regulatory , Chanelle Group and administratively to the General Manager of the Jordan site.
Plan, coordinate, and oversee Quality Control laboratory activities to ensure they are performed efficiently and in accordance with approved procedures, Good Laboratory Practice (GLP), current Good Manufacturing Practice (cGMP), data integrity principles, and applicable regulatory requirements.
Maintain effective oversight of laboratory operations, documentation, computerized systems, records, and results to ensure continued compliance, accuracy, traceability, and inspection readiness.
Ensure analytical testing, sampling, stability activities, specifications, methods, protocols, reports, and related laboratory controls are executed within approved guidelines and regulatory requirements.
Lead timely investigations of laboratory incidents, deviations, out-of-specification and out-of-trend results, and data integrity concerns; ensure robust root-cause analysis and effective corrective and preventive actions.
Review and approve laboratory procedures, analytical methods, specifications, qualification and validation documents, change controls, deviations, CAPAs, and investigation reports.
Establish and monitor controls that protect data integrity throughout the data lifecycle, including contemporaneous recording, review, retention, traceability, security, and governance of paper and electronic records.
Manage the available team effectively by assigning clear responsibilities, balancing workloads, building capability, and making the best use of personnel, equipment, laboratory capacity, and other resources.
Optimize laboratory operating costs and resource utilization while ensuring that efficiency or cost-saving measures never compromise product quality, patient safety, GLP, data integrity, or regulatory compliance.
Define and monitor relevant performance, quality, compliance, capacity, and cost indicators; identify risks and improvement opportunities and ensure timely action.
Provide training, coaching, and technical guidance to laboratory personnel on GLP, cGMP, data integrity, analytical procedures, investigations, and applicable regulatory expectations.
Support internal, corporate, customer, and regulatory inspections and audits by maintaining laboratory readiness, providing accurate information, addressing observations, and following corrective actions through completion.
Collaborate with Quality Assurance, Manufacturing, Regulatory Affairs, Supply Chain, Technical Services, and other functions to resolve quality issues and sustain compliant and reliable laboratory operations.
Bachelor’s degree in chemistry, chemical engineering, biology, or pharmaceutical science.
Minimum of fifteen (15) years of experience in Quality departments QA/QC in the pharmaceutical industry.
Experience in complaint investigation, sample evaluation, report generation.
Broad knowledge of cGMP governmental regulations and guidelines, and the ability to interpret and apply them.
Ability to communicate effectively with wide range of personnel, written and verbal.
Judgment and problem-solving - able to define decision criteria and determine the most appropriate course of action.
Data analysis - able to collect and analyze data to identify trends and detect problems and key issues.
Knowledge of conducting and leading GMP Audits (internal and external).
Computer skills (require using computerized systems).
Handle multiple tasks and comply with agreed completion due dates.
Strong hands-on analytical experience in analytical method development and validation is preferred.