Senior Manager, Quality Assurance(m/w/x)

Description

You will lead quality oversight for drug substance manufacturing, ensuring CMOs meet strict standards. By managing investigations and batch reviews, you'll drive excellence across the company's global supply chain.

Requirements

• •BS or BA degree
• •At least 10 years Quality Assurance experience
• •In-depth knowledge of GMPs, FDA/EMA regulations and ICH guidelines
• •Strong attention to detail
• •Knowledge in clinical and commercial product (desired)
• •Excellent verbal, written, and interpersonal communication skills
• •Experience leading through influence and cross-functional teamwork
• •Ability to prioritize tasks in fast-paced environments
• •Ability to adapt to changing priorities
• •Knowledge of biologics manufacturing and Quality Systems
• •Experience with good documentation practices and cGMP standards
• •Equivalent combination of education or experience

Tasks

• •Lead quality assurance for conjugation and drug substance manufacturing
• •Ensure CMO operations meet quality standards and regulatory requirements
• •Represent QA in internal and external cross-functional teams
• •Oversee deviations, investigations, risk assessments, and CAPAs
• •Review and approve internal and external compliance documentation
• •Perform detailed QA reviews of CMO-executed batch records
• •Review disposition packages for global regulatory compliance
• •Develop and maintain QA procedures and policies
• •Drive resolution of quality issues with contract manufacturers
• •Escalate quality risks to the company's management
• •Provide expert guidance on supplier manufacturing investigations
• •Support technology transfer activities and review related documents
• •Lead and participate in process improvement projects
• •Collaborate with stakeholders to resolve complex quality issues

Tools & Technologies

Benefits