Quality Control (QC) Manager

Role/Function Summary
The Quality Control Manager is responsible for performing and coordinating quality control activities to verify that clinical study execution, outsourced manufacturing/testing activities, study documentation, TMF records, vendor deliverables, and site-level processes are conducted in accordance with established protocols, approved plans, company SOPs, GCP, GMP, and applicable regulatory requirements.

This role is focused on checking execution against established requirements, identifying gaps, documenting observations, supporting issue resolution, and promoting inspection readiness. The Quality Control Manager will perform independent and/or operationally embedded reviews to confirm that approved plans and procedures are being followed consistently and effectively.

The role works closely with Clinical Operations, CMC, Quality Assurance, Regulatory Affairs, Supply Chain, CROs, CMOs, contract testing laboratories, study teams, and investigator sites to support compliant execution of clinical-stage pharmaceutical programs.

Responsibilities and Duties:
1. Clinical Study Quality Control

Review study execution and deliverables to ensure compliance with all study documents, including but not limited to:

Protocol requirements

Monitoring plans

Oversight plans

Study manuals, including lab manual and pharmacy manuals

Communication plans

Safety plans

GCP

Regulatory requirements

Company SOPs

Conduct quality reviews of study documents to ensure consistency and alignment across documents including:

Protocols and protocol amendments

Informed Consent Forms (ICFs)

Investigator Site Files

Monitoring Plans

Vendor Oversight Plans

Study Manuals

Recruitment Materials

Study-specific procedures

Identify inconsistencies, documentation gaps, missing approvals, version control issues, and deviations from approved processes.

Provide practical guidance to study teams regarding required corrections, documentation expectations, and compliance with established plans.

2. Study Quality Oversight Visit (SQOV)

Assist as needed with with Study Quality Oversight Visits (SQOVs) or other visits and/or audits required as part of a clinical trial.

Work with study teams to ensure issues identified are appropriately documented, tracked, investigated, corrected, and verified.

Document observations and work with study teams to implement improvements.

Share lessons learned and quality trends across studies.

3. Quality Issue Management

Serve as a key Clinical Operations quality resource for study teams.

Support identification, investigation, documentation, and resolution of quality issues.

Facilitate root cause analysis for recurring operational quality concerns.

Track quality issues through resolution and verify effectiveness of corrective actions.

Escalate significant quality risks to Quality and Clinical Operations leadership when appropriate.

Collaborate with QA when quality issues require formal CAPA or audit involvement.

4. TMF and Documentation Quality Control

Support development and implementation of TMF quality standards.

Perform routine QC review of documents and records in the TMF.

Perform periodic TMF audits.

Identify documentation gaps and partner with study teams to close deficiencies.

Maintain inspection-ready TMFs throughout the study lifecycle.

5. Clinical Operations SOP and Process Management

Participate in development, review, revision, and implementation of Clinical

Operations SOPs, Work Instructions, templates, and guidance documents.

Ensure operational procedures align with:

Regulatory requirements

Industry best practices

ICH-GCP guidelines

Identify process gaps and opportunities for operational improvement.

Lead or support continuous improvement initiatives within Clinical Operations.

Maintain consistency of operational practices across studies and regions.

6. Training and Quality Culture

Ensures that study specific training requirements are established.

Monitors and reports on study specific training compliance.

Works with study team to drive study specific compliance.

Promote a proactive quality culture across the Clinical Operations organization.

Communicate quality trends, lessons learned, and best practices to study teams.

7. Inspection Readiness Support

Support ongoing inspection readiness activities.

Conduct routine quality assessments and readiness reviews.

Assist study teams in preparing for:

Regulatory inspections

Sponsor audits

CRO audits

Support responses to audit and inspection observations as assigned.

Monitor completion of actions resulting from inspections and audits.

8. Quality Metrics and Trending

Develop and monitor Clinical Operations quality metrics.

Analyze quality trends and recurring compliance issues.

Prepare periodic quality reports for leadership.

Recommend process improvements as appropriate.

Support risk-based quality management initiatives.

9. Other Duties

Other duties from time to time as needed

Experience:
Minimum 6 years of QC experience in the pharmaceutical, biotechnology, or medical device industry.

Practical experience in one or more of the following areas:

Clinical Monitoring

Clinical Trial Management

Clinical Project Management

TMF Management

Vendor Oversight

Study Quality Oversight

Experience managing electronic Trial Master Files for multi-center, multi-national clinical trials.

Experience participating in regulatory inspections, sponsor audits, or inspection readiness activities preferred.

Demonstrated ability to identify quality risks and drive issue resolution in collaboration with operational teams.

Other Skills and Abilities:
Proficient in Microsoft Office Suite (Project, PowerPoint, Excel, Word); advanced Excel skills for tracking metrics is required.

Strong document review and quality assessment skills

Root cause analysis and problem-solving skills

Ability to identify operational risks and compliance gaps

Excellent attention to detail

Strong organizational and time-management skills

Effective communication and stakeholder management abilities.

Strong understanding of ICH guidelines (including E6, Q8, Q9), NMPA regulations, and regulatory guidelines applicable to investigational products and clinical trial.

Fluent in both Mandarin and English (written and spoken)

Physical Demands & Travel:
Willingness to travel domestically across China as needed. Ability to travel outside China a plus.

Ability to undertake regular study quality oversight visits, with expected travel of approximately 25–50% depending on site location and study needs.