- Develop and implement strategic plans to ensure compliance with regulatory requirements (e.g., FDA, EMA) and industry standards (e.g., cGMP) for pharmaceutical manufacturing.
- Lead and manage the quality assurance and manufacturing teams, providing guidance, mentorship, and support to ensure optimal performance and professional development.
- Establish and maintain quality management systems to ensure the consistent production of high-quality pharmaceutical products, including procedures for batch release, deviation management, and change control.
- Oversee the review and approval of batch records, analytical data, and other documentation to ensure compliance with regulatory requirements and internal quality standards.
- Conduct risk assessments and implement mitigation strategies to address potential quality issues and ensure product safety and efficacy.
- Collaborate with cross-functional teams, including R&D, regulatory affairs, and supply chain, to support product development, technology transfer, and commercialization activities.
- Lead investigations into quality incidents, deviations, and customer complaints, implementing corrective and preventive actions (CAPAs) as necessary to address root causes and prevent recurrence.
- Monitor key performance indicators (KPIs) and quality metrics to assess the effectiveness of quality systems and manufacturing processes, identifying opportunities for improvement.
- Ensure the successful execution of regulatory inspections, customer audits, and internal audits, providing support and guidance to ensure compliance and readiness.
- Stay current with industry trends, regulatory changes, and best practices in pharmaceutical quality assurance and manufacturing, providing guidance and recommendations to senior management as needed.
- Bachelor's degree in Pharmacy, Chemistry, Chemical Engineering, or a related field; advanced degree (e.g., Master's or Ph.D.) preferred.
- Minimum of 10 years of experience in quality assurance and manufacturing roles within the pharmaceutical industry, with at least 5 years in a leadership or management position.
- In-depth knowledge of pharmaceutical manufacturing processes, quality management systems, and regulatory requirements (e.g., FDA 21 CFR Part 210/211).
- Experience with aseptic processing, sterile manufacturing, and/or biologics manufacturing is highly desirable.
- Strong understanding of risk management principles, quality risk assessment methodologies, and statistical analysis techniques.
- Excellent leadership and management skills, with the ability to inspire and motivate teams to achieve ambitious goals and objectives.
- Proven track record of leading successful regulatory inspections (e.g., FDA, EMA) and customer audits, with a focus on compliance and continuous improvement.
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Director of Quality Operations - Miami, United States - EPM Scientific
Description
Director of Quality Operations
Location: Miami, Florida
Work situation: On-site
The Director of Quality Assurance and Manufacturing will be responsible for overseeing all aspects of quality assurance, quality control, and manufacturing operations within the pharmaceutical company. This critical role requires a strategic leader with a deep understanding of pharmaceutical manufacturing processes, regulatory requirements, and quality management systems. The successful candidate will lead a team of professionals to ensure compliance with regulatory standards, drive continuous improvement initiatives, and maintain the highest standards of product quality and safety.
Key Responsibilities:
Qualifications:
If you are interested in the Director of Quality role, don't hesitate to apply
