Manager of Quality Assurance
Skyhawk Therapeutics · Waltham, MA · 1 wk ago
HybridQuality Assurance$120k–$170k/yrFull-time
Responsibilities
- SOP Development & Management
- Training Program Administration
- Document Control Support
- Vendor Qualification Support
- Ad Hoc Quality Assurance Support
Education/Skills/Experience Requirements
- Bachelor’s degree in Life Sciences, Pharmacy, Chemistry, Engineering, or a related field required.
- Minimum of 5–7 years of progressive experience in Quality Assurance within a GxP-regulated environment (pharmaceutical, biotech, medical device, or related industry).
- Demonstrated experience authoring and managing SOPs and controlled documents.
- Hands-on experience with Veeva Vault QMS or equivalent electronic document management/quality management system.
- Experience supporting or leading vendor qualification programs.
- Familiarity with training program administration in a regulated environment.
- Proficient in Veeva Vault QMS (document management, training, and quality event modules).
- Strong knowledge of FDA regulations (21 CFR Parts 11, 210/211, 820), ICH guidelines, and GxP requirements.
- Excellent written and verbal communication skills with demonstrated ability to author clear, concise technical documents.
- Strong organizational skills with the ability to manage multiple priorities and deadlines simultaneously.
- High attention to detail and a quality-first mindset.
- Proficient in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook).