QA Specialist- Documentation

Manager of Quality Assurance

The Documentation Specialist, Quality Assurance position is responsible for providing comprehensive quality assurance support across regulated operations. This individual will partner closely with the Quality team to ensure that documentation, training, 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 detai

Responsibilities:

SOP Development & Management

• Author, format, review, and facilitate approval of Standard Operating Procedures (SOPs) in alignment with company quality standards and applicable regulatory requirements. Responsibilities include:

• 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• Managing document implementation activities, including issuance, communication, and archival of superseded versions.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

Training Program Administration

• Support the development, maintenance, and administration of the company’s training program within the Veeva platform. Responsibilities include:

• 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.

Document Control Support

• Manage the lifecycle of controlled documentation within the Veeva QMS. Responsibilities include:

• 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.

Ad Hoc Quality Assurance Support

• 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.

Education/Skills/Experience Requirements:

• Bachelor’s degree in Life Sciences, Pharmacy, Chemistry, Engineering, or a related field required.

• Minimum of 5 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).

Skyhawk Therapeutics is committed to pay transparency and equitable compensation practices. The base salary range for the Manager of Quality Assurance is $110,000-170,000 annually. This range reflects the minimum and maximum target for such position. Skyhawk Therapeutics will assess the appropriate level for a qualified candidate based on job-related skills, professional experience, and relevant education or training.

About Skyhawk

Skyhawk is committed to discovering, developing and commercializing small molecule therapeutics that modify RNA expression. We use our novel SkySTAR® platform (Skyhawk Small molecule Therapeutics for Alternative splicing of RNA) to develop drug candidates directed toward targets for some of the world’s most intractable diseases including neurological conditions, cancer, and traditionally “undruggable” targets.