Manager of Quality Assurance

Skyhawk Therapeutics • Waltham, MA

7d • $120,000 - $170,000

About The Position

Skyhawk Therapeutics is seeking a highly motivated Manager of Quality Assurance position to provide comprehensive quality assurance support across regulated operations. This individual will partner closely with the Quality team to ensure that documentation, training, vendor qualification, and quality systems are maintained in a state of audit readiness and compliance with applicable regulatory standards, including FDA, ICH, and GxP requirements. The Candidate operates within the Veeva Quality Management System (QMS) and is expected to function with a high degree of independence and attention to detail.

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).

Responsibilities

• Author, format, review, and facilitate approval of Standard Operating Procedures (SOPs) in alignment with company quality standards and applicable regulatory requirements.
• Drafting and formatting new SOPs and revising existing documents to ensure accuracy, clarity, and compliance.
• Facilitating the review and approval workflow for SOPs through the Veeva QMS, including coordinating with subject matter experts and quality leadership.
• Managing document implementation activities, including issuance, communication, and archival of superseded versions.
• Maintaining document control integrity within Veeva in accordance with applicable GxP and regulatory standards.
• Support the development, maintenance, and administration of the company’s training program within the Veeva platform.
• Developing and maintaining role-based Training Matrices to ensure appropriate assignment of training requirements to applicable personnel.
• Coordinating the rollout of training assignments within Veeva upon SOP issuance or revision.
• Tracking training completion and escalating overdue assignments to quality and functional management.
• Assisting in the identification of training gaps and recommending corrective actions as needed.
• Manage the lifecycle of controlled documentation within the Veeva QMS.
• Uploading, indexing, and classifying controlled documents in accordance with established document control procedures.
• Performing periodic document reviews to ensure records remain current, accurate, and version-controlled.
• Maintaining documentation archives and supporting retrieval of records during audits or regulatory inspections.
• Ensuring document metadata, access permissions, and retention schedules comply with applicable quality standards.
• Assist in the execution of the company’s Vendor Qualification program to ensure third-party suppliers and service providers meet applicable quality and regulatory requirements.
• Supporting the preparation and assembly of vendor qualification packages, including questionnaires, risk assessments, and approval documentation.
• Coordinating qualification activities with internal stakeholders and external vendors, including scheduling and follow-up.
• Maintaining vendor qualification records and qualification status within the QMS.
• Assisting in the periodic re-qualification and performance review of qualified vendors.
• Provide quality assurance support on an as-needed basis, which may include but is not limited to: Supporting internal audit preparation and observations management.
• Assisting with CAPA (Corrective and Preventive Action) documentation and tracking.
• Contributing to quality metrics compilation and reporting.
• Supporting inspection readiness activities and regulatory agency interactions.
• Providing QA review and approval of documents, records, and change controls as required.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager