Director, Quality Unit - 503B

Job Title: Director, Quality Unit - 503b

Location: Dayton, NJ

Job Type: Full-time

About Us:

As a developer, manufacturer, and supplier of essential medicines, Hikma Pharmaceuticals USA Inc. and its affiliates’ purpose is to put better health within reach, every day for millions of patients around the world. We are a trusted, reliable partner and dependable source of over 760 high-quality generic, specialty and branded pharmaceutical products that hospitals, physicians and pharmacists need to treat their patients across North America, the Middle East, North Africa and Europe. Through our global footprint of 30+ manufacturing plants, 8+ R&D centers, and 9,000+ empowered employees, we are committed to making high-quality medicines accessible to the people who need them.

Description:

We continue to be committed to building a diverse and inclusive team and encourage applications from candidates of all backgrounds. We are seeking a talented and motivated Director, Quality Unity - 503b. In this role, you will be responsible for handling several key responsibilities to ensure the highest standards of quality and compliance. This role requires hands-on leadership and a deep understanding of the compounding process as this role also requires a comprehensive knowledge of the specific regulations governing 503B outsourcing facilities, which are distinct from those for traditional pharmaceutical manufacturing. The FDA’s guidelines for 503B facilities are more stringent in certain areas, particularly regarding sterility and batch testing.

Key Responsibilities:

• Quality Assurance and Control:
  • Oversee the development and implementation of quality assurance programs targeted at 503B processes.
  • Manage the quality of compounded medications, which can be more complex due to the customization and variability in formulations. This includes ensuring the sterility and stability of our compounded products.
  • Ensure compliance with FDA regulations and cGMP
  • Conduct regular audits and inspections to maintain quality standards.
  • Take active leadership in FDA and other Health Authorities audits
• Team Leadership:
  • 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.
• Collaboration:
  • Work closely with compounding pharmacists, other departments such as manufacturing, R&D, Regulatory Affairs and supply chain.
  • Participate in cross-functional teams to address quality issues and improve processes.

Qualifications:

We value the skills and experiences candidates bring to the table. While we have listed some qualifications below, we encourage candidates to apply even if they do not meet all of them:

• 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.

Compensation:

Base Salary: $121,350 to $220,850 annually. The compensation for this position will be determined during the interview process and will vary based on multiple factors, including, but not limited to, work location, prior experience and job-related knowledge, relevant skills and expertise, current business needs, and market factors. The Talent Acquisition team can provide more details about the specific salary range for the job location during the hiring process.

What We Offer*:

• Annual performance bonus, commission, and share potential
• Auto enrollment in a Hikma-sponsored 401(k) program at a pre-tax contribution rate of 3% of eligible pay. Hikma will match 100% of the first 6% of eligible pay that you contribute
• A generous paid time off (PTO) bank starting with 20 days (prorated based on hire date). Additional days granted upon reaching work milestone anniversaries
• 3 personal days (prorated based on hire date)
• 11 company paid holidays
• Comprehensive benefits including health, dental, vision, mental health, disability, life insurance, prescription drug coverage, and a variety of voluntary benefits
• Employee discount program
• Wellbeing rewards program
• Safety and Quality is a top organizational priority
• Career advancement and growth opportunities
• Tuition reimbursement
• Paid maternity and parental leave

*Eligibility requirements apply to some benefits and depend on the job classification, role, and length of employment. Benefits are subject to change as well as specific plan or program terms.

Recruiters:

Please note that Hikma has a set roster of approved recruiters for specific roles agreed to in advance and does not accept unsolicited resumes or calls from third-party recruiters or employment agencies regarding open positions. In the absence of a signed agreement and approval from Hikma’s Human Resources department to submit resumes for a specific position, Hikma will not approve, nor will be under an obligation to make, any payment to such non-approved third-parties in the event a candidate they refer is hired by Hikma.

Equal Opportunity Employer:

Hikma Pharmaceuticals USA Inc. is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status, or other characteristics protected by law.