Master Compliance
Recruitment Lead - Pharma, Lifesciences & Medical Devices
Job Title:
GCP Associate Director (Part-Time) - W2
Start Date:
ASAP
Duration:
Through the end of 2025 (with potential to extend)
Location:
Remote
Hours per Week:
20 hours/week
Prior Experience working for FDA on inspections is a Must
Position Overview Our client is seeking an experienced
GCP Associate Director
to provide part-time support within their
GCP Audit & Inspection Management department . This individual will play a critical role in ensuring compliance with
Good Clinical Practice (GCP)
regulations, industry standards, and internal quality policies as defined by the organization’s Quality Management System.
This is a
remote, part-time position (20 hours/week)
ideal for a seasoned GCP professional who can immediately contribute to ongoing audit activities and help manage current workload overflow.
Key Responsibilities
Lead, coordinate, and execute
GCP audits
of investigator sites, vendors, and internal processes in accordance with established procedures.
Support
inspection readiness efforts , including preparation, documentation, and follow-up activities for regulatory agency inspections.
Participate in
due diligence and business development activities
to assess quality systems of potential partners or vendors.
Review and provide input on
Standard Operating Procedures (SOPs)
and Work Instructions (WIs) to ensure alignment with GCP and regulatory expectations.
Evaluate
audit responses
for adequacy and completeness, including corrective and preventive actions (CAPAs).
Contribute to
process improvement initiatives
within the Quality Assurance (QA) organization to strengthen compliance oversight.
Collaborate with cross-functional QA teams to provide
quality and compliance support
across clinical operations.
Leverage
previous FDA inspection experience
to provide subject matter expertise and ensure readiness for future inspections.
Qualifications & Experience
Education:
Bachelor’s degree (BS/BA) in Life Sciences, Pharmacy, or related field required.
Experience:
Minimum of
8 years of GCP Quality Assurance
experience, or an equivalent combination of education and experience.
Regulatory Expertise:
Demonstrated experience supporting or leading
FDA inspections
is
required .
Strong understanding of
ICH-GCP ,
FDA , and global regulatory requirements.
Proven ability to work independently, manage multiple priorities, and collaborate effectively across teams.
Seniority level Director
Employment type Contract
Job function Accounting/Auditing
Industries Pharmaceutical Manufacturing and Biotechnology Research
#J-18808-Ljbffr
GCP Associate Director (Part-Time) - W2
Start Date:
ASAP
Duration:
Through the end of 2025 (with potential to extend)
Location:
Remote
Hours per Week:
20 hours/week
Prior Experience working for FDA on inspections is a Must
Position Overview Our client is seeking an experienced
GCP Associate Director
to provide part-time support within their
GCP Audit & Inspection Management department . This individual will play a critical role in ensuring compliance with
Good Clinical Practice (GCP)
regulations, industry standards, and internal quality policies as defined by the organization’s Quality Management System.
This is a
remote, part-time position (20 hours/week)
ideal for a seasoned GCP professional who can immediately contribute to ongoing audit activities and help manage current workload overflow.
Key Responsibilities
Lead, coordinate, and execute
GCP audits
of investigator sites, vendors, and internal processes in accordance with established procedures.
Support
inspection readiness efforts , including preparation, documentation, and follow-up activities for regulatory agency inspections.
Participate in
due diligence and business development activities
to assess quality systems of potential partners or vendors.
Review and provide input on
Standard Operating Procedures (SOPs)
and Work Instructions (WIs) to ensure alignment with GCP and regulatory expectations.
Evaluate
audit responses
for adequacy and completeness, including corrective and preventive actions (CAPAs).
Contribute to
process improvement initiatives
within the Quality Assurance (QA) organization to strengthen compliance oversight.
Collaborate with cross-functional QA teams to provide
quality and compliance support
across clinical operations.
Leverage
previous FDA inspection experience
to provide subject matter expertise and ensure readiness for future inspections.
Qualifications & Experience
Education:
Bachelor’s degree (BS/BA) in Life Sciences, Pharmacy, or related field required.
Experience:
Minimum of
8 years of GCP Quality Assurance
experience, or an equivalent combination of education and experience.
Regulatory Expertise:
Demonstrated experience supporting or leading
FDA inspections
is
required .
Strong understanding of
ICH-GCP ,
FDA , and global regulatory requirements.
Proven ability to work independently, manage multiple priorities, and collaborate effectively across teams.
Seniority level Director
Employment type Contract
Job function Accounting/Auditing
Industries Pharmaceutical Manufacturing and Biotechnology Research
#J-18808-Ljbffr