SRG, the leader in the Life Sciences human capital industry, is looking for a Contract Clinical Quality and Process Lead Consultant.

*THIS IS A REMOTE POSITION!

Our Client's Global Medicines Development (GMD) is looking for a motivated CQPE Lead who is ready to apply knowledge of business practices and regulations in a fast-paced, real-world environment. The candidate will work in an innovative and collaborative environment focused on US, EU, UK, and other Health Authority regulations and requirements.

Work with a multidisciplinary team to help standardize GMD activities within and across programs through preparation of SOPs and personnel training. Specifically, the candidate will develop or oversee the development, maintenance and roll out of processes and procedures to ensure alignment with current best practice guidelines, regulation updates and requirements related to audit corrective actions and a Corporate Integrity Agreement and may assist with training responsibilities. The candidate will support internal and external audits, regulatory inspections, inspection readiness activities, clinical study teams, and issue management including deviations, change controls and CAPAs.

WHAT YOU NEED TO HAVE:

• BS and a minimum of 10 years of experience in a pharmaceutical, research, and/or clinical training area.
• GCP
• Identify gaps ahead of time
• Process oriented
• SOP Writing
• Risk Assessment
• Investigations for deviations (audit like)
• Process improvements

JOB RESPONSIBILITIES include, but are not limited to:

• Contribute to the development and lead the implementation of continuous quality improvement activities for GMD. Lead and conduct process gap assessments to ensure the development of appropriate SOPs, policies, work instructions and forms for GMD to ensure regulatory compliance in conjunction with being "fit for purpose" / "stream-lined" to contribute to efficiency.
• Create draft documents, circulate for review and finalize new versions of policies, standard operating procedures, work instructions and forms for use in GMD.
• Support internal and external audits and regulatory inspections related to GMD; oversee the implementation of appropriate and timely CAPAs, track action items required for audit/audit findings and ensure completion by targeted due dates.
• Collaborate with internal and/or external stakeholders to ensure management of quality issues including deviations, CAPAs, and change controls.
• Develop and lead the implementation of inspection readiness activities.
• Contribute to and implement a self-inspection program to ensure GMD activities related to clinical trials are performed in accordance with GCP, company SOPs, applicable laws and regulations.
• Collaborate with internal stakeholders to share self-inspection observations and regulatory intelligence across GMD programs.

Key Performance Indicators:

• High quality, timely SSU deliverables/documentation/data in adherence to prevailing legislation, ICH/GCP, IRB/IEC, Health Authority, and SOP requirements.
• Successful site activation within planned timelines.
• Effective supplier oversight, risk management and mitigation strategy.

** "SRG values your application, our team will be in touch to schedule interviews with candidates moving forward in the process."

Impellam Group and its brands are equal-opportunity employers committed to diversity and inclusion. All qualified applicants will receive consideration without regard to race, color, religion, gender, sexual orientation, pregnancy or maternity, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application, interview process, pre-employment activity, and the performance of crucial job functions.

If you require additional disability considerations, modifications, or adjustments please let us know by contacting HR-InfoImpellamNA@impellam.com or fill out this form to request accommodations.