Title:  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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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 and holistic Validation Master Plan (VMP)
• development and implementation of Hikma’s validation standards and standard operating procedures.

1. Compliance Training and Education:

• Ensure the proper development and delivery of comprehensive training programs for employees at all levels, emphasizing compliance with relevant quality standards and regulations. 

2. Supplier and Vendor Quality Management:

• Establish and oversee a comprehensive vendor qualification and management program, ensuring that suppliers meet our quality expectations.

3. Quality Metrics and Reporting:

3. • Define and monitor key performance indicators (KPIs) to track the effectiveness of quality initiatives and provide regular reports to senior management. 
4. Risk Management:
   • Implement risk-based approaches to quality management, identifying and mitigating potential quality risks across the organization. 
5. Networking [Internal/External]:
   • Collaborate with cross-functional teams, including R&D, Manufacturing, Supply Chain, and Regulatory Affairs, to ensure product quality and compliance throughout the product lifecycle.
   • Stay current with industry trends, new regulations, and emerging technologies related to injectables and sterile manufacturing, and provide recommendations to senior management on quality improvements and risk mitigation strategies.

6. Team Development:
   • Attract, manage, and develop a high-performing Quality Assurance team by providing coaching, mentoring, and professional development opportunities.
7. Team Composition: 164 ftes broken down as follows;

Qualifications

• Bachelor’s degree in pharmacy, Chemistry, or related field.  Advanced degree is preferred.
• Minimum of 15 years of progressive leadership experience in Quality Assurance roles within the pharmaceutical industry, with a strong focus on injectables and sterile manufacturing.
• In-depth knowledge of local and global regulatory requirements and Quality Standards for Injectable Pharmaceuticals such as FDA regulations and guidelines, GMP, and ICH guidelines.
• Must possess a strong knowledge of quality systems for parenteral drug products per CFR 210/211 and combination products per CFR 820 requirements related to prefilled syringe and intravenous bag manufacturing. 
• Experience in sterile manufacturing of aseptically filled and terminally sterilized processes, sterility assurance and sterilization validation. 
• Strong understanding of Quality Management Software Systems and Tools, including document control, change control, deviation management, and batch record review.
• Proven track record of successfully leading and managing Quality Assurance functions and teams in a fast-paced, highly regulated environment and driving a culture of Quality and Compliance.
• Experience conducting and managing internal and external audits, including interactions with regulatory authorities.
• Excellent leadership, communication, and problem-solving skills with ability to effectively interact with internal teams, external partners and regulatory agencies.
• Strong analytical skills and attention to detail.
• Ability to work collaboratively with cross-functional teams Internationally and influence at all levels of the organization.