Hikma Pharmaceuticals
Associate Director, Quality Unit - 503B
Hikma Pharmaceuticals, Franklin Park, New Jersey, United States
Overview
The Associate Director of Quality Unit oversees key responsibilities to ensure the highest standards of quality and compliance. This role requires hands-on leadership and a comprehensive knowledge of the compounding process and the regulations governing 503B outsourcing facilities, which have distinct requirements from traditional pharmaceutical manufacturing. The FDA’s guidelines for 503B facilities are particularly stringent regarding sterility and batch testing. This role is crucial for maintaining the integrity and safety of compounded products, ensuring they meet necessary standards for patient care. Responsibilities
Quality Assurance and Control: Oversee the development and implementation of quality assurance programs targeted at 503B processes. Manage the quality of compounded medications, addressing complexity due to customization and variability in formulations, including ensuring sterility and stability of products. Ensure compliance with FDA regulations and cGMP. Conduct regular audits and inspections to maintain quality standards. Lead FDA and other Health Authority audits. Lead and mentor the quality unit team. Provide training and development opportunities for staff. Foster a culture of continuous improvement and quality excellence. Regulatory Compliance: Maintain up-to-date knowledge of regulatory requirements. Ensure all products meet regulatory standards before release. Manage documentation and reporting for regulatory submissions. Operational Oversight: Direct oversight of compounding processes, including aseptic techniques and equipment validation. Oversee batch record creation, materials testing, and quality systems. Lead investigations into non-conformances and implement corrective actions. Ensure proper aseptic techniques and equipment validations are followed. Collaborate with compounding pharmacists and other departments (manufacturing, R&D, Regulatory Affairs, supply chain). Participate in cross-functional teams to address quality issues and improve processes. Qualifications: Education:
Bachelor’s or Master’s degree in Pharmacy, Chemistry, or a related field. Experience:
Extensive experience in pharmaceutical quality assurance/control, preferably in a 503B compounding environment. Skills:
Strong leadership, communication, and problem-solving skills. Proficiency in quality management systems and regulatory compliance. Pay: $121,350.00 - $220,850.00 per year What We Offer
Clean climate-controlled working environment 401k employer match up to 6% of contributions 23 vacation/personal days 11 paid Company holidays Employee discount program Safety and Quality is a top organizational priority Career advancement/growth opportunities Tuition Reimbursement Maternity and Parental Leave Details
Seniority level:
Director Employment type:
Full-time Job function:
Quality Assurance, Strategy/Planning, and Product Management Industries:
Pharmaceutical Manufacturing and Manufacturing About the Company: Hikma Pharmaceuticals Additional context: This description reflects the role and responsibilities for a quality leadership position focused on 503B compounding operations and regulatory compliance.
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The Associate Director of Quality Unit oversees key responsibilities to ensure the highest standards of quality and compliance. This role requires hands-on leadership and a comprehensive knowledge of the compounding process and the regulations governing 503B outsourcing facilities, which have distinct requirements from traditional pharmaceutical manufacturing. The FDA’s guidelines for 503B facilities are particularly stringent regarding sterility and batch testing. This role is crucial for maintaining the integrity and safety of compounded products, ensuring they meet necessary standards for patient care. Responsibilities
Quality Assurance and Control: Oversee the development and implementation of quality assurance programs targeted at 503B processes. Manage the quality of compounded medications, addressing complexity due to customization and variability in formulations, including ensuring sterility and stability of products. Ensure compliance with FDA regulations and cGMP. Conduct regular audits and inspections to maintain quality standards. Lead FDA and other Health Authority audits. Lead and mentor the quality unit team. Provide training and development opportunities for staff. Foster a culture of continuous improvement and quality excellence. Regulatory Compliance: Maintain up-to-date knowledge of regulatory requirements. Ensure all products meet regulatory standards before release. Manage documentation and reporting for regulatory submissions. Operational Oversight: Direct oversight of compounding processes, including aseptic techniques and equipment validation. Oversee batch record creation, materials testing, and quality systems. Lead investigations into non-conformances and implement corrective actions. Ensure proper aseptic techniques and equipment validations are followed. Collaborate with compounding pharmacists and other departments (manufacturing, R&D, Regulatory Affairs, supply chain). Participate in cross-functional teams to address quality issues and improve processes. Qualifications: Education:
Bachelor’s or Master’s degree in Pharmacy, Chemistry, or a related field. Experience:
Extensive experience in pharmaceutical quality assurance/control, preferably in a 503B compounding environment. Skills:
Strong leadership, communication, and problem-solving skills. Proficiency in quality management systems and regulatory compliance. Pay: $121,350.00 - $220,850.00 per year What We Offer
Clean climate-controlled working environment 401k employer match up to 6% of contributions 23 vacation/personal days 11 paid Company holidays Employee discount program Safety and Quality is a top organizational priority Career advancement/growth opportunities Tuition Reimbursement Maternity and Parental Leave Details
Seniority level:
Director Employment type:
Full-time Job function:
Quality Assurance, Strategy/Planning, and Product Management Industries:
Pharmaceutical Manufacturing and Manufacturing About the Company: Hikma Pharmaceuticals Additional context: This description reflects the role and responsibilities for a quality leadership position focused on 503B compounding operations and regulatory compliance.
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