Director, Quality Assurance

Responsibilities

• Maintain and improve the company’s quality system per FDA ICH Q7 requirements for drug substances
• Manage, support, and participate in regulatory inspections and customer quality audits
• Oversee quality functions including deviations, CAPA, NCMR, change control, and batch record review
• Manage Quality Data Analytics and provide KPI data to the QA department
• Oversee the document control function, including master records and history records
• Establish headcount needs, recruit, train, and manage QA personnel
• Perform cGMP internal audits and surveillance across sites
• Resolve day-to-day compliance issues and ensure continuous improvement of the quality management system

Requirements

• Bachelor's Degree in a science-related field
• 10+ years of work experience in a Quality field within a GMP company
• Strong knowledge of GMP, ISO, FDA, EU, and international regulations
• Excellent written and oral communication skills, including technical writing and data analytics
• Ability to manage critical projects to deadlines within an interdisciplinary team
• Proficiency with Microsoft Office (Word, Excel, PowerPoint)

Preferred Qualifications

• Master's Degree or Ph.D. in a science-related field
• 5+ years of management experience
• Professional certifications such as QPA, CQA, or CQE

Benefits

• Competitive salary and annual performance bonus
• Comprehensive Medical, Dental, and Vision coverage
• 401(k) plan with employer contribution
• Paid vacation, personal, and sick days

About the Company

Bachem is a leading, innovation-driven company specializing in the development and manufacture of peptides and oligonucleotides. With over 50 years of expertise, Bachem provides products for research, clinical development, and commercial application to pharmaceutical and biotechnology companies worldwide.