Senior Manager, Clinical Quality Assurance

United Pharma; North Carolina; Hybrid; USD 150,000 - 190,000; Part time

Job summary

United Pharma is seeking a Sr. Manager, Clinical Quality Assurance (contract) to serve as an internal expert on GCP, ICH, and global regulatory requirements, owning the standards, training, and oversight to keep clinical trials audit-ready.

The role leads SOP development, DOT eQMS Clinical module, and GCP training, providing QA oversight of CROs, vendors, and quality events throughout trial conduct.

Qualifications

• Bachelor's degree in a scientific field or related discipline.
• 7–10 years of clinical quality and/or clinical operations experience in biotech/pharma/CRO.
• GCP/ICH knowledge, regulatory requirements, and QMS experience.

Responsibilities

• Review and oversee clinical QA documentation (SOPs, protocols, ICFs, reports, study-level docs).
• Collaborate with Clinical Operations to maintain GCP, ICH, and internal procedures compliance.
• Perform quality assessments of clinical processes, documentation, and outputs.
• Document quality activities, including deviations, CAPAs, and quality events.
• Define standards for SOP development, revision, and implementation.
• Serve as QA SME for assigned studies or programs.
• Provide proactive quality guidance to study teams and lead mitigation strategies.
• Lead audits of CROs, vendors, and investigator sites.
• Oversee vendor qualification and oversight activities.
• Ensure audit findings are tracked and addressed.
• Own investigations of quality events and deviations; drive root cause analysis and CAPA development.
• Track CAPAs and coordinate timely closure.
• Support inspection readiness activities (document review, gap assessments, back-room support).
• Partner with Clinical Operations to support quality across programs.
• Develop tools, templates, and quality metrics; contribute to QMS improvements.

Skills

7–10 years experience in clinical QA/0

GCP knowledge

ICH guidelines

FDA regulations

QMS experience

SOP development

Audit readiness

CAPA management

Problem solving

Communication skills

Organizational skills

Ownership mindset

Education

Bachelor's degree in a scientific or related discipline

Job description

The Sr. Manager, Clinical Quality Assurance (contract) is an internal expert on how GCP, ICH, and global regulatory requirements QMS, owning the standards, training, and oversight that keep clinical trial activities audit-ready. This role sets the approach on Clinical SOPs, the DOT eQMS Clinical module, and GCP training, and provides QA oversight of CROs, vendors, and quality events throughout trial conduct.

Key Responsibilities

• Review and provide oversight of clinical QA documentation including SOPs, protocols, ICFs, reports, and study-level documents
• Collaborate with Clinical Operations teams in maintaining compliance with GCP, ICH, and internal procedures
• Perform quality assessments on clinical processes, documentation, and outputs
• Maintain accurate documentation of quality activities, including deviations, CAPAs, and quality events
• Apply expertise to define standards for SOP development, revision, and implementation
• Serve as a QA subject matter expert for assigned clinical studies or programs
• Provide proactive quality guidance to study teams, identifying risks and leading mitigation strategies
• Lead audits of CROs, vendors, and investigator sites
• Oversee vendor qualification and oversight activities
• Ensure audit findings are tracked and addressed appropriately
• Own investigation of quality events and deviations
• Drive root cause analysis and CAPA development
• Track CAPAs and coordinate timely closure
• Provide expertise for inspection readiness activities (e.g., document review, gap assessments, back-room support)
• Partner with Clinical Operations and other functions to support quality across clinical programs
• Spearhead development of tools, templates, and quality metrics
• Contribute to continuous improvement initiatives within the QMS

Experience & Skills and Work Environment

Experience & Skills

• Bachelor's degree in a scientific or related discipline (advanced degree preferred)
• 7-10 years of experience in clinical quality and/or clinical operations in a biotech, pharmaceutical, or CRO environment
• Experience in gene therapy, biologics, or advanced therapeutics strongly preferred
• Strong knowledge of GCP, ICH guidelines, FDA regulations, and global regulatory requirements
• Experience with Quality Management Systems (QMS) and SOP development
• Exposure to audits, CAPAs, and inspection readiness activities
• Ability to work independently while operating effectively in a collaborative environment
• Strong problem-solving and critical thinking skills
• Excellent communication and interpersonal skills
• High level of organization and ability to manage multiple priorities
• Willingness to take on increasing responsibility and ownership
• Remote or hybrid (as applicable)
• Work is normally performed: at a desk
• Lifting requirements: Under 20 lbs
• Must be willing to work outside of normal business hours, as necessary, to support the clinical project team members on different time zones.