Sr. Clinical QA Specialist
Sr. GCP Quality Specialist
Location: Hybrid in MA
We are seeking a Senior GCP Quality Specialist to play a critical role in maintaining the integrity and compliance of clinical research operations. In this global role, you will lead audits of clinical processes and vendors, ensuring they meet regulatory requirements and internal quality standards.
Responsibilities:
- Lead clinical audits: Conduct in-depth audits of clinical processes and vendors across multiple divisions to ensure compliance with global regulations and internal protocols.
- Risk-based quality assessments: Identify key risk areas in clinical operations and execute targeted audits to address compliance gaps.
- Vendor evaluations: Partner with subject matter experts (e.g., software quality) to perform comprehensive vendor assessments and ensure all provided services meet regulatory standards.
- Drive accountability: Prepare clear, actionable audit reports and communicate findings with stakeholders to facilitate timely resolution.
- Manage non-conformances: Oversee clinical vendor compliance issues, working cross-functionally to implement corrective actions.
- Stay ahead of regulations: Continuously monitor and interpret evolving regulatory guidelines, such as ISO standards, FDA medical device regulations, and Good Clinical Practice (GCP) requirements, to keep the organization compliant.
- Regulatory readiness: Support preparation and participation in regulatory inspections related to clinical operations.
- Quality improvement initiatives: Contribute to the Clinical Quality Assurance Community of Practice by identifying opportunities for process enhancements and best practices.
Qualifications:
- A Bachelor's degree in Science, Health, or a related field.
- At least 5 years of experience in a regulated industry such as medical devices, pharmaceuticals, or a similar field.
- Hands-on auditing experience in a GCP-regulated environment or equivalent.
- Willingness and ability to travel as needed for audits and inspections.
- Lead Auditor certification in is a plus
- Must be authorized to work in the US without Visa sponsorship
FAQs
Congratulations, we understand that taking the time to apply is a big step. When you apply, your details go directly to the consultant who is sourcing talent. Due to demand, we may not get back to all applicants that have applied. However, we always keep your CV and details on file so when we see similar roles or see skillsets that drive growth in organisations, we will always reach out to discuss opportunities.
Yes. Even if this role isn’t a perfect match, applying allows us to understand your expertise and ambitions, ensuring you're on our radar for the right opportunity when it arises.
We also work in several ways, firstly we advertise our roles available on our site, however, often due to confidentiality we may not post all. We also work with clients who are more focused on skills and understanding what is required to future-proof their business.
That's why we recommend registering your CV so you can be considered for roles that have yet to be created.
Yes, we help with CV and interview preparation. From customised support on how to optimise your CV to interview preparation and compensation negotiations, we advocate for you throughout your next career move.