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Quality & Regulatory
Associate Director, QA - External API Direct Hire PA
Job ID: 15916 Direct Hire PA
Our client is one of the world's largest biotech/pharma companies with both clinical & commercial biologics and pharmaceutical products. Their site in the suburbs of Philadelphia, PA is seeking an experienced QA professional to join their team and oversee all external API production at CMO/CTO partners.
The main function of this role is to provide Quality oversight of API CMOs & CTOs and to support regulatory inspections.
Responsibilities include but are not limited to;
• Identify, assess and resolve quality related issues that impact cGMP compliance or regulatory filings
• Track and evaluate any non-conformances that occur during the manufacture of cGMP material.
• Identify and prevent or resolve issues that could impact the continuity of supply of existing API products.
• Make decisions on the acceptability of product for release to market.
• Supplier improvement programs & regulatory inspection support
• Assess method and process validation protocols and reports
• Support and contribute to new product introduction, product launches, and product integration.
• Develop action plans for remediation activities for product and/or quality systems and communicate activities to CMO and leadership.
• Perform batch record, deviation, validation, change control, customer complaint processing and review
• Participate and conduct contractor audits to assure compliance to GMPs, regulatory filings (DMF, NDA, MAA, etc.), FDA, EMEA, and ICH guidelines
Formal descriptions can be supplied for interested candidates.
Qualified candidates will have a BS degree or higher with 10+ years of experience for Associate Director role. The Hiring Manager has the ability to consider less experienced candidates with relevant experience at a Manager-level as well.
Candidates who require a Visa transfer may be considered if authorized to work in the US for at least 3+ years. Must be commutable to the site in the Philadelphia suburbs or able to relocate with limited financial assistance. Some work from home capability may also be available.
All resumes will be kept strictly confidential until you choose to pursue a specific opportunity with one of our clients.