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
