Sr. Director, Quality Operations

Job Summary

We are seeking a highly experienced and knowledgeable professional to join our company as Site Senior Director Quality– Operations, for our Cherry Hill Site - US Injectables. The ideal candidate will have a minimum of 15 years of experience in the pharmaceutical industry, with a strong focus on injectables and sterile manufacturing.

As the Site Senior Director Quality, you will be a key leader responsible for ensuring that our pharmaceutical Injectables in the US meet and exceed the highest industry standards for safety, efficacy, and compliance. You will implement our strategic direction, oversight, and leadership to our Quality department, fostering a culture of continuous improvement and adherence to regulatory requirements.

Key Responsibilities

1. Strategic Quality Implementation Leadership:

• Implement strategic direction and leadership in the development and implementation of quality standards, policies, and procedures across the US organization.
• Implement the company's quality strategy, aligning it with the overall business objectives.
• Provide direction for quality initiatives implementation, ensuring they support product excellence, compliance, and customer satisfaction.

 

1. Regulatory Compliance:

• Ensure that all manufacturing, packaging, labelling, and distribution operations of the company's injectable and sterile product portfolio comply with applicable local and global regulations and industry standards, e.g. FDA, EMA, GCC and cGMP guidelines and CFR 820 requirements for combination products and processes.
• Lead interactions and manage inspections and quality audits, both internal and external (FDA/EMEA), and establish corrective and preventive actions to address identified deficiencies.

 

1. Quality Systems and Processes:

• Implement, maintain, and continuously improve effective quality systems (QMS) to ensure it meets or exceeds industry standards.
• Drive the implementation of robust quality control and assurance processes.

 

1. Quality Assurance and Control:

• Direct the activities of the Quality Assurance and Quality Control teams, ensuring product quality at every stage of the manufacturing process.
• Implement effective measures for batch release, stability testing, and deviation management.  This includes Document Control, Change Control, Deviation & CAPA Management, and Batch Record Review.

 

1. Quality Sterility Assurance and Environmental Monitoring Control:

• Develop and implement microbiology lab and sterility assurance strategies, policies, and procedures for the company's manufacturing facilities.
• Develop and implement microbiology strategies, policies, and procedures for the company's manufacturing facilities, including environmental monitoring, microbiological testing, and microbial identification.
• Maintain the company's sterile manufacturing operations, including cleanroom facilities, sterilization processes, and aseptic processing techniques.
• Oversee the risk assessments program and root cause analyses for sterility assurance and microbiology issues and support in developing an effective corrective and preventive program.

 

1. Validation / Qualification of Equipment

• Ensure the development and implementation of Hikma’s validation philosophy and approach.
• Ensure the development and implementation of Hikma’s Validation Policy, validation framework an