Senior Quality Specialist - QMS & Doc Control

d04444ef-3464-49c4-81aa-2d3eeb7dfc39•Durham, NC

8d•Onsite

About The Position

The Senior Quality Specialist – Quality Management Systems (QMS) serves as a senior-level subject matter expert responsible for the administration, oversight, continuous improvement, and regulatory compliance of Humacyte’s Quality Management Systems, with primary emphasis on GMP Document Control, Training, Records Management, and electronic Quality Management Systems (eQMS). This position provides technical expertise and independent oversight of controlled documentation processes, including document creation, revision, approval, issuance, reconciliation, archival, and retention. The Senior Quality Specialist ensures that GMP documentation and associated records are maintained in accordance with applicable regulatory requirements, company policies, established procedures, and data integrity principles. The individual will serve as a key Quality Systems representative, providing guidance to cross-functional stakeholders, supporting internal and external regulatory inspections, identifying and mitigating compliance risks, and driving process improvements to strengthen QMS effectiveness and operational efficiency.

Requirements

High School or GED required, Bachelor’s Degree, preferred
5-7 years of experience in Quality within the biotechnology, pharmaceutical, or medical device field, required
Minimum of 6–8 years of progressive experience in pharmaceutical, biotechnology, biologics, or medical device manufacturing environments, with substantial experience supporting GMP Quality Management Systems.
Minimum of 5 years of direct experience in GMP Document Control, Quality Systems administration, regulated documentation management, or related Quality Assurance functions.
Demonstrated experience independently managing complex document control activities and regulated records management processes.
Experience with electronic Quality Management Systems, preferably MasterControl or a comparable platform.
Experience supporting internal audits, regulatory inspections, Quality Events, investigations, change controls, and CAPA activities.
Strong understanding of regulations CFR and FDA Guidance for Industry
Strong understanding of applicable FDA regulations, including 21 CFR Parts 210, 211, and 11, and relevant ICH guidance.
Comprehensive understanding of controlled document lifecycle management, GMP records retention, document issuance, reconciliation, and archival requirements.
Understanding of cGMP compliance in the biotech/bioprocessing manufacturing environment
Effectively communicates high level concepts to Quality and scientific leadership
Strong oral and written communication skills
Clearly communicates with co-workers and supervision and communicates in a timely manner
Strong understanding of root cause analysis; change control requirements; Deviation/CAPA and other fundamental elements of Quality Systems
Advanced working knowledge of current Good Manufacturing Practices (cGMP), current Good Documentation Practices (cGDocP), and data integrity principles.

Responsibilities

Serve as a subject matter expert for GMP Document Control, Records Management, and associated Quality Management System processes.
Provide independent oversight and administration of regulated documentation throughout the document lifecycle, ensuring compliance with applicable cGMP, cGDocP, data integrity, and internal procedural requirements.
Assess existing QMS processes to identify compliance gaps, operational inefficiencies, and opportunities for standardization and continuous improvement.
Develop, revise, review, and approve controlled Quality Systems documentation, including SOPs, Work Instructions, forms, templates, and associated records, within established authorization levels.
Collaborate with Quality Assurance, Manufacturing, Quality Control, Validation, MSAT, Regulatory Affairs, and other departments to ensure effective implementation and maintenance of Quality Systems.
Support the development, monitoring, and reporting of Quality Systems performance metrics.
Oversee the issuance, distribution, reconciliation, archival, retrieval, and retention of controlled documentation in accordance with approved procedures.
Ensure documentation processes support traceability, accuracy, completeness, contemporaneous recording, and appropriate record retention.
Lead or support periodic assessments of training and document control processes to identify documentation discrepancies, compliance risks, and opportunities for improvement.
Evaluate and resolve complex documentation discrepancies, including missing, incomplete, improperly issued, or unreconciled controlled documents.
Partner with applicable departments to implement sustainable corrective actions addressing recurring documentation and records management deficiencies.
Serve as a key Quality Systems resource for administration, maintenance, and continuous improvement of electronic document management and eQMS platforms, including MasterControl or equivalent systems.
Support implementation, configuration, testing, and enhancement of electronic Quality Systems workflows in collaboration with system owners, IT, Validation, and business process stakeholders.
Participate in user acceptance testing, change control assessments, procedural updates, and training activities associated with QMS system enhancements.
Identify opportunities to streamline document lifecycle management, improve electronic workflow efficiency, and reduce manual administrative activities.
Support the preparation of audit responses, investigation documentation, and CAPA commitments related to assigned Quality Systems processes.
Promote a proactive culture of regulatory compliance, inspection readiness, and continuous improvement.