Job Description: The EVP of Quality will be responsible for developing and executing the company's quality strategy, ensuring that all products meet the highest standards of safety, efficacy, and regulatory compliance. This senior executive role requires a strategic leader with extensive experience in quality management within the pharmaceutical industry.
Key Responsibilities:
- Develop and implement a comprehensive quality strategy aligned with the company's business goals and regulatory requirements.
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Oversee all quality assurance (QA) and quality control (QC) activities, ensuring compliance with FDA, EMA, and other global regulatory standards.
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Lead and mentor the QA and QC teams, fostering a culture of continuous improvement and operational excellence.
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Establish and maintain robust quality systems, including SOPs, validation protocols, and risk management processes.
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Ensure timely and accurate completion of quality-related documentation, including batch records, deviations, CAPAs, and audit reports.
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Serve as the primary point of contact for regulatory agencies and manage all regulatory inspections and audits.
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Collaborate with other departments, such as R&D, Manufacturing, and Regulatory Affairs, to ensure quality considerations are integrated into all processes and products.
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Monitor and analyze quality performance metrics, implementing corrective actions as needed to drive improvements.
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Lead investigations into product quality issues and develop effective resolutions to prevent recurrence.
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Stay current with industry trends, regulatory changes, and best practices in quality management.
Qualifications:
- Bachelor’s degree in Pharmacy, Chemistry, Biology, or a related field; advanced degree preferred.
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Minimum of 15 years of experience in quality management within the pharmaceutical industry, with at least 5 years in a senior executive role.
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In-depth knowledge of global regulatory requirements (FDA, EMA, ICH) and quality systems.
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Proven track record of successfully leading quality assurance and quality control functions.
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Exceptional leadership, communication, and interpersonal skills.
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Strong analytical and problem-solving abilities.
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Ability to work effectively in a fast-paced, dynamic environment.
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Proficiency in quality management software and Microsoft Office Suite.