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Quality and Regulatory Compliance Manager

4 months ago

Framingham, United States Katalyst HealthCares & Life Sciences Full time
Responsibilities: Ensure compliance with quality standards and regulatory requirements for products subcontracted to external entities, adhering to cGMPs and quality directives. Oversee the efficiency of the Quality System implemented between the company and subcontractors, managing activities such as complaints, deviations, change controls, and non-conformities to ensure product production, control, and release meet quality requirements. Lead assigned projects, including new product launches. Identify and address quality-related issues affecting compliance, regulatory filings, or other risks to company products. Collaborate with subcontractors to develop and implement solutions for quality issues. Manage customer complaints, determining corrective actions in collaboration with Contract Manufacturing Organizations (CMOs) and identifying trends. Anticipate and resolve issues that could impact the continuity of product supply. Review and approve subcontractor validation protocols, Master Documents, and significant deviations and investigations, identifying trends to reduce quality anomalies. Maintain constant communication with relevant stakeholders.

Requirements:

Excellent oral and written communication skills for cGMP documentation. Experience in third-party manufacturing quality and regulatory functions, or similar plant experience. Interpersonal skills for effective communication with suppliers and customers to develop strong relationships. Significant technical knowledge in pharmaceutical and medical device industries, particularly in handling product complaints and associated regulations. Understanding of various drug product manufacturing processes, including oral dosages, semi-solids, liquids, injectables, lyophilized products, and medical drug/device combinations. Proficient in project management. Bachelor of Science degree. - years of experience in Pharmaceutical Operations or Quality Operations with a focus on applying cGMPs in the pharmaceutical or related regulated industry.