Location: Amman, Jordan
Job Type: Full-time
Hashtag: #LI-AA2
About Us:
For over 45 years, Hikma Pharmaceuticals has been putting better health within reach, every day, by creating high-quality medicines and making them accessible to those who need them. We are helping to shape a healthier world that enriches all our communities, and our global team of 9,500+ empowered employees are central to this mission.
As a trusted and reliable partner of over 800 high-quality generics, specialty and branded pharmaceutical products, we are driven to improve access to medicine. Through our 29 manufacturing plants, 3 R&D hubs across the MENA, North America and Europe, our footprint allows us to play a critical role in serving patients.
Description:
We are looking for a talented Associate Manager, Quality Complianceto join us. At Hikma you’ll be supported by a culture of progress and belonging where people are encouraged to develop, wellbeing is prioritised and our inclusive approach values contributions from all. We’re seeking candidates who embody our values: Innovative, driven to keep learning; Caring, genuinely compassionate in their work; and Collaborative, eager to solve problems together.
If you want to be part of a team that cares about impact, this is the place for you.
Key Responsibilities:
Strategic
- Providing support and guidance to the Hikma injectable sites including compounding by:
- Lead auditing coordination, approach, and execution for injectables/Oral/ laboratory/Data Integrity manufacturing/contract manufacturing CMOs
- Ensuring internal injectable/Oral Hikma site compliance with Hikma’s rules and policies through internal audits
- Following up on all observations by Hikma and third parties which includes CAPA plan implementation and ensuring timely completion.
Technical capabilities
- Providing concerned Hikma employees with the required guidance related to the injectables/Oral/laboratory/Data Integrity manufacturing/contract manufacturing CMOs manufacturing processes to ensure that the related international standards and specifications are applied on all Hikma concerned processes
- Investigating and studying different problems related to injectables/Oral/ laboratory/Data Integrity manufacturing/contract manufacturing CMOs manufacturing processes that might occur in all Hikma concerned functions and recommending the corrective actions accordingly
- Ensuring that health and safety regulations are followed in the concerned processes to avoid accidents in the workplace during executed audits protecting the auditors
- Ensuring that the entire injectables/Oral/laboratory/Data Integrity manufacturing/contract manufacturing CMOs manufacturing processes are in compliance with the set standard operating procedures (SOPs
- Ensuring that all injectables/Oral/laboratory/Data Integrity manufacturing/contract manufacturing CMOs manufacturing processes, activities, procedures comply with related internal/external regulations
- Conducting periodic checks to ensure that all injectables/Oral/laboratory/Data Integrity manufacturing/contract manufacturing CMOs manufacturing processes are performed correctly and conforming the international standards and specifications
- Assessing different Hikma functions compliance with the set standards and specifications in order to detect the deviations and recommending the necessary corrective actions accordingly
- Providing the Corporate Compliance Director with periodic reports illustrating the work flow of the injectables/Oral/microbiology, laboratory/Data Integrity manufacturing/contract manufacturing CMOs manufacturing processes through Hikma corporate functions
- Documenting different related transactions in all Hikma corporate functions to be used as a reference in the future when needed
- Performing other duties related to the job as assigned by the direct supervisor
Administrative
- Preparing periodic reports with respect to the Compliance (Injectables/Orals) function's activities and achievements to be submitted to the direct supervisor
- Ensuring that instructions, circulars and organizational and technical decisions are followed and applied
- Implementing Internal quality auditing and Hikma subsidiaries audit program, ensuring that Hikma Internal sites maintain a state of cGMP compliance where all activities within the Hikma Pharmaceutical function comply with the adopted standards, policies, and procedures.
- implementing follow up auditing program for Hikma internal sites, ensuring that response is covered and communicated properly with Hikma quality management.
- Providing Technical Support to Injectable/Oral strategic Under license projects, by qualifying suppliers, upgrading systems of our partners, conducting gap analysis and providing the needed support before/ during and after authorities audits to sites, up to end of registration of the product.
- Assisting in process standardization through Hikma based on international best practices, in addition to supporting the functions’ managers in taking the required corrective and preventive actions.
- Supporting Hikma new projects by providing the needed technical and administrative support for Hikma new projects with new partners (Toll manufacturers, Finished product formulators).
- Participating in audits whenever Hikma audited by third party or authority. By presenting Corporate Compliance role, auditing system.
Qualifications:
We are looking for candidates whose experience and skills align closely with the qualifications outlined below:
- B.Sc. degree in Chemistry, Biological, Microbiology, Chemical Engineering or equivalent
- M.Sc. degree in TQM or equivalent
- (10) years of experience in a related position, of which at least (5) in a supervisory position
- Experience in a pharmaceutical industry, Oral and Injectables manufacturing.
- Quality certification on auditing e.g. ASQ/ISO9001…. etc
Skills:
Performs moderately difficult tasks using job related applications, Office applications, and other relevant programs, as well as uses the functions of the internet effectively
Performs complex data analysis utilizing multi-sourced set of data, prepares reports illustrating the results through professional graphs, charts, and other visual aids
- Documentation / Recording Information
Applying and using various techniques in documenting and recording information in written or electronic/magnetic formats
Demonstrates mastery of the language; near native; ability to read, understand and write extremely difficult or abstract prose, a wide variety of vocabulary, idioms, colloquialisms, and slang
Represents the company externally within the government sector and develops and maintains good rapport with its employees
Possesses knowledge in laws and legislations of several countries that Hikma operates in, including MENA region, USA and Europe
Ability to manage projects through effective planning, implementation, monitoring and completion of projects, while ensuring best utilization of resources; time, human resources, budget
Learn more about Hikma in Jordan hikma-jordan-factsheet-aug-2025-en.pdf
