مدير جودة البحث والتطوير

Job description

Job Purpose:

This position works closely with key stakeholders across Research & Development, including Formulation Development, Analytical Research, Clinical R&D, and Regulatory Affairs, as well as with Manufacturing, Procurement, and Quality functions at the site. the position is responsible for managing and overseeing the Quality Management System within the Analytical Research and Formulation Development departments, ensuring its effective implementation, maintenance, and continuous improvement.

The position ensures that R&D activities, processes, procedures, and quality documentation comply with applicable current Good Manufacturing Practices (cGMP), regulatory requirements, Hikma policies, and relevant divisional procedures. It also provides quality oversight and guidance throughout product development to support compliant, efficient, and timely execution of R&D activities.

Duties & Responsibilities:

1. Lead and manage the day-to-day activities of the R&D Quality team, providing direction, setting priorities, promoting effective teamwork, monitoring performance, identifying development needs, and ensuring appropriate training and onboarding of team members.

2. Establish, maintain, and continuously improve the Quality Management System within R&D, including Formulation Development, Analytical Research, pilot plant, laboratories, and warehouse activities, ensuring that processes, procedures, training requirements, and quality documentation comply with applicable company standards and regulatory requirements.

3. Provide Quality oversight throughout product development, scale-up, submission, technology transfer, process validation, and the pre-approval and lifecycle phases, ensuring that activities are completed in accordance with approved requirements, timelines, and quality standards. This includes oversight of submission and scale-up batches and the first three process validation batches, where applicable.

4. Review and approve product- and process-related quality documentation, including manufacturing batch records, product specifications, sampling plans, validation and qualification protocols and reports, analytical method validation documentation, risk assessments, deviations, chang controls, and supporting submission documentation.

5. Provide Quality oversight of analytical investigations and data integrity, including review of OOS, OOT, laboratory deviations, laboratory incidents, associated raw data, and electronic records, to ensure compliance with applicable data integrity requirements and 21 CFR Part 11.

6. Ensure effective management and follow-up of deviations, CAPAs, laboratory investigations, and related quality actions, including assessment of root cause, timely implementation of corrective and preventive actions, and verification of CAPA effectiveness.

7. Ensure the qualification, calibration, maintenance, and compliant operation of R&D and pilot plant equipment and facilities, and oversee relevant supporting systems, including equipment logbooks, R&D inventory management, warehouse and additional storage areas, material control, expiry-date monitoring, consumption tracking, and originator sample storage and distribution.

8. Monitor regulatory and quality compliance and support inspection readiness, including interpretation and implementation of applicable FDA, ICH, European, cGMP, GLP, safety, and internal requirements; performance of internal audits; participation in corporate and external audits, due diligence activities, and regulatory inspections; preparation and follow-up of responses and action plans; and support for deficiency letters received from health authorities.

9. Adhere to the Company policies e.g. purchasing, travel, EHS, IT, Data Privacy Policy and all other policies in the Company

10. Act according to the Hikma behavioral standards at any point in time, such as the Code of Conduct.

QUALIFICATIONS

• Minimum: Bachelor’s degree in life scientific discipline (Pharmacy, Chemistry/Chemical engineering or Biochemistry) plus 10 years combined experience in R&D (such as Formulation Development, Analytical Research) and demonstrated experience in Quality Assurance
• Preferred: Master’s degree in Pharmacy, Chemistry/Chemical engineering or Biochemistry plus 8 years experience in R&D and Quality in pharmaceutical industry specifically
• Strong verbal and written communication skills (Intermediate Level in English is a must)
• Demonstrated expert knowledge of 21 CFR, ICH, ISO, cGMPs, USP, current FDA regulations, EP, current EMEA regulations
• Ability to foster a team-based spirit
• Collaboration & Teamwork
• Customers focus Internal/External
• Developing and Empowering others
• Problem solving & Decision Making