Senior Director - Commercial Product Quality - External Supply

September 16

Apply Now

Receive Emails with Similar Jobs

Business Wire

WebsiteLinkedInAll Job Openings

Public Relations • Press Release Distribution • Investor Relations • SEC filing • SEO

501 - 1000

Description

• Ensure the commercial products at CMOs are manufactured, packed, labelled, stored, and transported in a controlled way • Lead and develop a staff of Quality professionals • Manage quality issues and changes at CMOs • Perform batch record review • Lead batch related deviation handling and effective CAPA implementation at CMO • Provide quality support on product commercial supply

Requirements

• Bachelor of Science degree or above, in a related scientific discipline • Minimum 12 years pharmaceutical or biotechnology industry experience • In-depth GMP experience in a quality and manufacturing function • Prior experience in commercial GMP batch release • In-depth knowledge of Quality principles, concepts, industry practices and standards • Working knowledge and experience with US, EU, ICH and/or China GMP regulations • Excellent interpersonal skills, including communication, negotiations, facilitations • Experience in working in a cross-functional and international environment • Good presentation skills • Ability to work independently • Spoken/Written fluency in English required • Strong PC literacy required; MS Office skills (Outlook, Word, Excel, PowerPoint)

Benefits

• Medical • Dental • Vision • 401(k) • FSA/HSA • Life Insurance • Paid Time Off • Wellness