Stirling Q&R Ltd
Head of Quality Assurance
Stirling Q&R Ltd, Boston, Massachusetts, us, 02298
A leading organization in the pharmaceutical industry is seeking a Director to lead their Clinical Quality Assurance (CQA) efforts with a strong focus on Good Clinical Practices (GCP) and Good Laboratory Practices (GLP). This pivotal role will ensure that the company’s drug development programs meet regulatory standards while fostering a culture of continuous improvement.
Key Responsibilities:
Develop and implement a comprehensive GCP quality assurance strategy that aligns with ICH E6(R2) guidelines and applicable regulatory requirements.
Lead GCP audits for clinical trials, investigator sites, clinical laboratories, and computerized systems to ensure compliance with protocols, standard operating procedures (SOPs), and regulatory standards.
Oversee the creation and maintenance of a risk-based approach to clinical quality assurance, including risk assessment and mitigation strategies.
Ensure proper documentation and record-keeping practices are established to maintain GCP compliance and data integrity throughout clinical trials.
Collaborate with cross-functional teams to address quality issues, implement corrective and preventive actions (CAPAs), and drive continuous improvement in GCP processes.
Provide expert GCP guidance to clinical operations teams, investigators, and external partners to maintain compliance and enhance study quality.
Lead inspection readiness activities, including conducting mock inspections to prepare for regulatory agency inspections (e.g., FDA, EMA).
Develop and deliver GCP training programs for staff, investigators, and clinical research personnel.
Stay current with evolving GCP regulations, guidelines, and industry best practices to ensure the organization remains compliant and implements necessary changes.
Qualifications:
A Bachelor’s degree in life sciences or a related field; an advanced degree is preferred.
A minimum of 10 years of experience in clinical quality assurance roles with a strong focus on GCP.
In-depth knowledge of ICH GCP guidelines, FDA regulations, and other relevant international standards.
Certification as a Quality Auditor (CQA) or equivalent certification is preferred.
Proven experience leading regulatory inspections and managing relationships with regulatory agencies.
Strong understanding of clinical trial processes, including protocol development, study conduct, and clinical data management.
Excellent analytical, communication, and leadership skills.
Ability to influence and collaborate effectively across all levels of the organization.
This role is essential for ensuring the integrity of clinical trials, protecting subject rights and safety, and maintaining compliance with Good Clinical Practice standards throughout the organization's research activities. The ideal candidate will play a crucial role in driving quality assurance initiatives that align with the company's mission to advance innovative medical solutions.
Job Type:
Full-time
Pay:
From $200,000.00 per year
Ability to Commute:
Boston, MA (Required)
Work Location:
In person
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Key Responsibilities:
Develop and implement a comprehensive GCP quality assurance strategy that aligns with ICH E6(R2) guidelines and applicable regulatory requirements.
Lead GCP audits for clinical trials, investigator sites, clinical laboratories, and computerized systems to ensure compliance with protocols, standard operating procedures (SOPs), and regulatory standards.
Oversee the creation and maintenance of a risk-based approach to clinical quality assurance, including risk assessment and mitigation strategies.
Ensure proper documentation and record-keeping practices are established to maintain GCP compliance and data integrity throughout clinical trials.
Collaborate with cross-functional teams to address quality issues, implement corrective and preventive actions (CAPAs), and drive continuous improvement in GCP processes.
Provide expert GCP guidance to clinical operations teams, investigators, and external partners to maintain compliance and enhance study quality.
Lead inspection readiness activities, including conducting mock inspections to prepare for regulatory agency inspections (e.g., FDA, EMA).
Develop and deliver GCP training programs for staff, investigators, and clinical research personnel.
Stay current with evolving GCP regulations, guidelines, and industry best practices to ensure the organization remains compliant and implements necessary changes.
Qualifications:
A Bachelor’s degree in life sciences or a related field; an advanced degree is preferred.
A minimum of 10 years of experience in clinical quality assurance roles with a strong focus on GCP.
In-depth knowledge of ICH GCP guidelines, FDA regulations, and other relevant international standards.
Certification as a Quality Auditor (CQA) or equivalent certification is preferred.
Proven experience leading regulatory inspections and managing relationships with regulatory agencies.
Strong understanding of clinical trial processes, including protocol development, study conduct, and clinical data management.
Excellent analytical, communication, and leadership skills.
Ability to influence and collaborate effectively across all levels of the organization.
This role is essential for ensuring the integrity of clinical trials, protecting subject rights and safety, and maintaining compliance with Good Clinical Practice standards throughout the organization's research activities. The ideal candidate will play a crucial role in driving quality assurance initiatives that align with the company's mission to advance innovative medical solutions.
Job Type:
Full-time
Pay:
From $200,000.00 per year
Ability to Commute:
Boston, MA (Required)
Work Location:
In person
#J-18808-Ljbffr