Director Quality Operations

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