We are seeking an experienced Senior Manager, R&D Quality Assurance to independently lead Clinical Quality Assurance (CQA) activities for assigned clinical studies. This role will serve as a QA Program Lead, providing oversight to ensure study conduct is compliant with the protocol, Good Clinical Practice (GCP), regulatory requirements, and internal procedures. The position will also lead inspection readiness and audit activities and provide support to various quality and compliance functions.
Key Responsibilities:
Program Lead (PL) Responsibilities
* Independently perform the QA Program Lead role as outlined in the Program Lead Plan.
* Oversee study compliance with protocols, GCP, SOPs, and regulatory guidance.
* Lead or co-lead Investigator Site Audits (ISAs), including planning, execution, reporting, and CAPA follow-up.
* Manage and report key study risks, especially for Phase 2 & 3 trials.
* Support Quality Event (QE) activities related to sponsor, site, and vendor non-compliance.
* Provide guidance to junior QA staff and other Program Leads.
* Maintain effective collaboration with cross-functional teams and external partners.
Inspection Readiness
* Own and drive inspection readiness for assigned studies.
* Create, assign, and track inspection readiness workstreams across departments.
* Support or lead regulatory inspection preparations (FDA, EMA, PMDA, etc.).
* Lead Site Inspection Readiness Training visits and manage inspection-related CAPAs.
* Serve as front room/backroom support during inspections and advise on team assignments.
Audit and Vendor Oversight
* Support QA Vendor Quality Oversight (VQO) audit teams.
* Provide input into vendor audit scope and review CAPA responses.
* Co-audit vendor audits, as needed.
Process Quality Excellence (PQE) Support
* Participate in and lead process audits and multi-study quality events.
* Contribute to process improvements, SOP/WI updates, and regulatory intelligence reviews.
Required Qualifications:
* Bachelor’s degree in a life science or health-related discipline required.
* Master’s degree preferred.
* Minimum 7 years of GCP Quality Assurance or related clinical trial oversight experience.
* Demonstrated experience in:
o Late-phase clinical trial oversight
o Audit leadership
o Inspection readiness and Health Authority inspections
o Quality event and CAPA management
o Cross-functional study team collaboration
Preferred Qualifications:
* Experience across clinical phases (1–3)
* Familiarity with outsourced audit management
* Knowledge of Clinical Supply Chain, Clinical Operations, Regulatory Affairs, Drug Safety, and Data Management
* In-depth understanding of GCP regulations and global agency guidance (FDA, EMA, PMDA, etc.)
* Strong leadership, communication, and project management skills
* Comfortable with hybrid work schedules and occasional travel (10–25%)
Contract Terms:
* Type: 6-Month Contract
* Schedule: Hybrid (Remote + Onsite as needed)
* Interview Process: 2 rounds
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