Manager of Quality Assurance

Manager of Quality Assurance

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.

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  • Managing document implementation activities including issuance communication and archival of superseded versions.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

Vendor Qualification Support

• Assist in the execution of the companys Vendor Qualification program to ensure third-party suppliers and service providers meet applicable quality and regulatory requirements. Responsibilities include:
  • 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.

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:

• Bachelors degree in Life Sciences Pharmacy Chemistry Engineering or a related field required.
• Minimum of 57 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 $00 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 worlds most intractable diseases including neurological conditions cancer and traditionally undruggable targets.