Senior Quality Assurance Manager for Biopharmaceuticals
hace 4 días
Job Overview:
Mission: Lead the development, implementation, and oversight of a robust Quality Management System (QMS) for biopharmaceutical products.
Key Responsibilities:
1. Develop and implement a tailored QMS for biopharmaceutical products to ensure high-quality standards and compliance.
2. Oversee key Quality Systems and deliverables associated with drug development, playing a pivotal role in the product pipeline's success.
3. Drive cross-functional projects and Quality initiatives within CMC Teams, providing expert Quality Assurance input for all aspects of drug development.
4. Conduct comprehensive risk assessments and communicate Quality risks within the Quality organization, shaping strategic risk management approaches.
5. Facilitate timely resolution of Quality issues on deviations, Investigations, CAPAs, and Complaints, maintaining product and process integrity by fostering effective interdepartmental relations and promoting a culture of quality across the organization.
6. Manage change control throughout the drug development process, ensuring smooth transitions and continuous improvement.
7. Lead internal quality audits, supplier audits, process/product improvement projects, supplier evaluation surveys, and disposition activities to ensure operations meet the highest standards of quality and efficiency.
Requirements:
+8 years of quality-related experience in the pharmaceutical or biopharmaceutical industry of biological products.
Strong knowledge of GMP and regulatory requirements (e.g., EU, FDA, ICH).
Technical working proficiency in quality systems. Knowledge of devices for biologics (e.g., combination product) is an advantage.
Good knowledge and skills in using advanced personal computer productivity programs for word processing, spreadsheets, database manipulations, statistical analytical tools, and flow charts.
Strong organizational, analytical mindset, and problem-solving skills to perform varied tasks in a functionally independent and consistent manner with clear focus on timelines and objectives.
Ability to influence and collaborate with others. Good written and verbal communication skills in English are essential.
Estimated Salary Range:
$110,000 - $140,000 per year, depending on qualifications and location.
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