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Quality Assurance Manager
4 weeks ago
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· Develop and implement quality assurance policies and procedures in compliance with regulatory standards and guidelines, including FDA, EMA, and other applicable authorities.
· Oversee the execution of quality control processes throughout the product lifecycle, from development and manufacturing to distribution and post-market surveillance.
· Lead and manage a team of quality assurance professionals, providing guidance, training, and support to ensure adherence to quality standards and continuous improvement.
· Conduct internal audits and inspections to assess compliance with quality management systems and identify areas for improvement.
· Collaborate with cross-functional teams, including R&D, manufacturing, regulatory affairs, and supply chain, to resolve quality issues and drive process improvements.
· Serve as a primary point of contact for regulatory agencies during inspections and audits, ensuring timely responses and corrective actions as needed.
· Stay current on industry trends, regulations, and best practices in quality assurance and proactively implement changes to maintain compliance and improve efficiency.
· Develop standardized production, quality, and customer-service standards
· Identify potential risks before they become a problem, focusing on root cause analysis and preventive action
· Perform internal and external quality audits and compile detailed reports of findings
· Build a strong team through coaching, mentoring, specific training and performance evaluations
Requirements:
- Bachelor's degree in pharmacy, chemistry, biology, or related field; advanced degree preferred.
- Minimum of 10 years of experience in quality assurance within the pharmaceutical industry, with at least 5 years in a managerial or leadership role.
- Strong knowledge of regulatory requirements, including cGMP, GLP, and ICH guidelines, as well as experience with FDA inspections and audits.
- Excellent leadership, communication, and interpersonal skills, with the ability to effectively collaborate with cross-functional teams and external stakeholders.
- Proven track record of implementing and managing quality management systems and driving continuous improvement initiatives.
- Detail-oriented with strong analytical and problem-solving skills, capable of identifying root causes of quality issues and implementing corrective actions.
- Certified Quality Auditor (CQA) or Certified Quality Manager (CQM) credentials preferred.
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