Quality Operations Director

Key Responsibilities:

• Provide strategic oversight and leadership for the Quality Assurance, Document Control, and Quality Supplier Management departments.
• Oversee implementation and adherence to cGMP, ICH, FDA, and ISO quality standards.
• Maintain and oversee a robust quality management system.
• Collaborate effectively with cross-functional teams to ensure seamless product launches.
• Proactively identify, assess, and mitigate quality risks.
• Oversee the Quality Operations department, including 11 direct reports

Qualifications:

• Bachelor's degree in a relevant field, with a minimum of 14 years of experience (10 years in Quality, 8 years managing quality personnel). Alternatively, a Master's degree with a minimum of 12 years of experience (10 years in Quality, 8 years managing quality personnel) is acceptable. Prior leadership experience is essential.
• In-depth understanding of regulatory requirements for the biopharmaceutical and/or medical device industry.
• Excellent written and verbal communication skills.
• Demonstrated ability to lead and develop a high-performing team.

Preferred Qualifications:

• Prior experience in the medical device or biotechnology industry (biologics)
• Internal and external quality audit oversight