SciPro
Divisional Principal Headhunter, Clinical Development
SciPro is partnered with a commercialised clinical-stage pharmaceutical company that's searching for a
Clinical Quality Assurance Manager
to join their team full-time. This is a fantastic opportunity to work at an innovative and growing company with strong financial stability.
Due to its commercial drug portfolio (soon to be expanded), the company’s revenue funds ongoing development.
This is a hybrid role with 3 days onsite in the Bay Area.
Responsibilities
Lead and manage all GCP-related audits (site, vendor, internal, TMF, CSRs) and oversee study-specific Clinical Study Audit Plans using a risk-based approach.
Serve as the QA representative to clinical study teams, providing compliance guidance and reviewing/approving clinical study documents, SOPs, and guidance materials.
Drive continuous improvement of the Clinical Quality Management System (CQMS), including creation and revision of GCP-compliant SOPs and processes.
Support and manage GCP inspection readiness and participate in GCP, GMP, GLP, PV, sponsor, site, and CRO regulatory inspections.
Lead investigations of clinical non-compliance events, oversee CAPA implementation, and perform QA quality metric analyses (protocol deviations, safety data, trends, etc.).
Review and approve investigational product temperature excursions, maintain GCP regulatory surveillance, and provide training, mentoring, and cross-development for QA team members.
Qualifications
BA/BS degree in a relevant field (or equivalent experience) with 6+ years of clinical research experience and a solid understanding of Quality Systems supporting GCP activities.
Strong experience developing GCP processes aligned with industry best practices, including training and implementation.
Seniority level:
Mid-Senior level
Employment type:
Full-time
Job function:
Quality Assurance and Science;
Industries:
Biotechnology Research and Pharmaceutical Manufacturing
Referrals increase your chances of interviewing at SciPro by 2x
Medical insurance
Vision insurance
401(k)
Get notified about new Quality Assurance Manager jobs in
San Francisco Bay Area .
Menlo Park, CA $131,000.00-$164,000.00 2 weeks ago
#J-18808-Ljbffr
Clinical Quality Assurance Manager
to join their team full-time. This is a fantastic opportunity to work at an innovative and growing company with strong financial stability.
Due to its commercial drug portfolio (soon to be expanded), the company’s revenue funds ongoing development.
This is a hybrid role with 3 days onsite in the Bay Area.
Responsibilities
Lead and manage all GCP-related audits (site, vendor, internal, TMF, CSRs) and oversee study-specific Clinical Study Audit Plans using a risk-based approach.
Serve as the QA representative to clinical study teams, providing compliance guidance and reviewing/approving clinical study documents, SOPs, and guidance materials.
Drive continuous improvement of the Clinical Quality Management System (CQMS), including creation and revision of GCP-compliant SOPs and processes.
Support and manage GCP inspection readiness and participate in GCP, GMP, GLP, PV, sponsor, site, and CRO regulatory inspections.
Lead investigations of clinical non-compliance events, oversee CAPA implementation, and perform QA quality metric analyses (protocol deviations, safety data, trends, etc.).
Review and approve investigational product temperature excursions, maintain GCP regulatory surveillance, and provide training, mentoring, and cross-development for QA team members.
Qualifications
BA/BS degree in a relevant field (or equivalent experience) with 6+ years of clinical research experience and a solid understanding of Quality Systems supporting GCP activities.
Strong experience developing GCP processes aligned with industry best practices, including training and implementation.
Seniority level:
Mid-Senior level
Employment type:
Full-time
Job function:
Quality Assurance and Science;
Industries:
Biotechnology Research and Pharmaceutical Manufacturing
Referrals increase your chances of interviewing at SciPro by 2x
Medical insurance
Vision insurance
401(k)
Get notified about new Quality Assurance Manager jobs in
San Francisco Bay Area .
Menlo Park, CA $131,000.00-$164,000.00 2 weeks ago
#J-18808-Ljbffr