PharmaLex is hiring a
Manager, Quality Management & Compliance in Worldwide

Summary

PharmaLex is hiring a Key Contributor for their QMC team to deliver high-quality services to clients. The individual will manage, implement, and execute projects, provide Quality Compliance support, perform audits, develop SOPs, and assist with investigations, among other responsibilities. A BA/BS degree in a Life Science or Chemistry field and minimum 7 years of experience in a Quality Assurance/Quality Operations role are required.

Requirements

• BA/BS in a Life Science or Chemistry field of study
• Minimum of 7 years of experience within a Quality Assurance/Quality Operations role for Aseptic Production of sterile products within the Pharma Industry
• Knowledgeable of FDA, EMA, ICH, and other industry guidelines from major regulatory bodies as they relate to cGXP operations

Responsibilities

• Execute Vendor, CMO, Service provider audits on behalf of clients as needed in the area of expertise, write audit reports and coordinate with client on acceptable responses
• Assist clients with development of QMS and Quality Systems SOPs based on the clinical or commercial phase of the product
• Provide technical consulting as needed for client GXP concerns and formalize responses in writing within 1 week period
• Assist with compliance gap assessments as needed including Annex 1 reviews and propose remediations for gaps found
• Participate in at least one Business Development event per year, including presentations, workshops, podcasts, creation of published content

Benefits

Equal opportunity employer