Associate Director, Quality Assurance (GCP & Clinical Research)
for each section heading. Use - for lists. Use
for prose.
We must not include any markdown fences. Just raw HTML.
Let's structure:
About the role
Provide strategic quality leadership and oversight across assigned Quality Assurance (QA) programs, with a strong focus on clinical research, clinical operations, pharmaceutical development, and GxP-regulated activities. Influence quality outcomes across multiple functional areas, business units, and customer engagements through expert guidance, risk-based decision making, and oversight of quality systems and compliance programs. Lead and coordinate QA initiatives supporting customer accounts, clinical and functional operations, audit and inspection readiness programs, and quality management systems at a regional and/or global level. Partner with stakeholders to assess and promote compliance with applicable regulatory requirements, industry guidelines, and company procedures while driving continuous improvement, risk mitigation, patient safety, and operational excellence. This position is best suited for candidates with substantial Clinical Quality Assurance (CQA), GCP, GxP, pharmaceutical, biotechnology, CRO, healthcare, or clinical research experience. While experience supporting technology-enabled quality systems is valuable, candidates with a predominantly IT Quality Assurance background and limited exposure to regulated clinical environments may not possess the preferred qualifications for this role.
Responsibilities
- Serve as the primary QA liaison for assigned customers, sponsors, clinical operations groups, and internal functional areas.
- Provide Quality Assurance oversight and guidance of quality issues, deviations, CAPAs, risk assessments, and compliance initiatives.
- Serve as a subject matter expert in GCP, GxP, ICH guidelines, clinical trial regulations, and pharmaceutical quality requirements.
- Provide guidance, interpretation, training, and consultation regarding regulations, industry standards, corporate policies, and quality expectations to clinical and operational teams.
- Support inspection readiness activities and support responses to regulatory authority inspections, sponsor audits, and customer audits.
- Assist in the enhancement of Quality Assurance policies, procedures, and risk management programs by providing recommendations to regional and global QA leadership.
- Author, review, and maintain Quality Assurance Standard Operating Procedures (SOPs) and serve as a representative on global quality governance initiatives, if assigned.
- Support customer audits and regulatory inspections and support the development, implementation, and verification of corrective and preventive action (CAPA) plans.
- Support documentation, investigation, reporting, and resolution of compliance-related issues.
- Support Quality Management with proposal reviews, quality strategy development, and quality metric reporting.
- Analyze audit trends, compliance metrics, root causes, and quality indicators to identify opportunities for process improvement and risk reduction.
- Lead or participate in cross-functional quality improvement initiatives and strategic projects.
- Mentor, develop, and manage QA personnel while fostering a culture of quality, compliance, accountability, and continuous improvement.
- Promote patient safety, data integrity, regulatory compliance, and quality excellence throughout the organization.
Qualifications
- Bachelor's degree in Life Sciences, Nursing, Pharmacy, Healthcare Administration, Biology, Chemistry, or related scientific discipline, or equivalent combination of education and experience preferred
- Minimum of 10 years of Quality Assurance experience within pharmaceutical, biotechnology, CRO, medical device, healthcare, or clinical research environments.
- Extensive experience interpreting, applying, and overseeing compliance with Good Clinical Practice (GCP) standards within a clinical research environment.
- Strong knowledge of pharmaceutical research and development processes, clinical trial conduct, and global regulatory environments.
- Demonstrated experience in GxP Quality Assurance.
- Experience conducting audits, authoring audit reports, evaluating findings, and managing CAPA activities is an advantage.
- Proven ability to lead complex quality initiatives and influence stakeholders across multiple functions and organizational levels.
- Excellent problem-solving, risk assessment, negotiation, and decision-making skills.
- Strong organizational, communication, leadership, and team-building abilities.
- Experience managing multiple projects, priorities, timelines, and competing business needs.
- Ability to establish and maintain effective working relationships with customers, regulators, vendors, and internal stakeholders.
- Proficiency with Microsoft Office applications and quality management systems.
We could also have a Skills section pulling out the skill-related bullets from Qualifications (problem-solving, communication, leadership, etc.) but that would duplicate content. The instruction: "Prefer a few substantive sections over many thin ones." We could combine Qualifications and Skills into one section? But they ask to use headings for those categories if content exists. We have Qualifications content; we also have skills content within Qualifications. Could we create a separate Skills section with those skill bullets, and keep Qualifications for education/experience? That would split content but not duplicate if we move those bullets out. However we must preserve ALL substantive information; moving is fine as long as we keep it somewhere. Let's decide: We'll keep Qualifications for education/experience/minimum years etc. And Skills for problem-solving, communication, leadership, team-building, managing multiple projects, relationships, proficiency with MS Office and QMS. Also "Experience conducting audits, authoring audit reports, evaluating findings, and managing CAPA activities is an advantage." could be under Skills.
Thus we need to parse Qualifications list into two groups.
Original Qualifications paragraph includes:
- Bachelor's degree ... preferred
- Minimum of 10 years of QA experience ...
- Extensive experience interpreting, applying, and overseeing compliance with GCP standards ...
- Strong knowledge of pharmaceutical R&D processes, clinical trial conduct, and global regulatory environments.
- Demonstrated experience in GxP Quality Assurance,
- Experience conducting audits, authoring audit reports, evaluating findings, and managing CAPA activities is an advantage.
- Proven ability to lead complex quality initiatives and influence stakeholders across multiple functions and organizational levels.
- Excellent problem-solving, risk assessment, negotiation, and decision-making skills.
- Strong organizational, communication, leadership, and team-building abilities.
- Experience managing multiple projects, priorities, timelines, and competing business needs.
- Ability to establish and maintain effective working relationships with customers, regulators, vendors, and internal stakeholders.
- Proficiency with Microsoft Office applications and quality management systems.
We'll split:
Qualifications (education/experience/knowledge):
- Bachelor's degree ...
- Minimum of 10 years ...
- Extensive experience interpreting, applying, and overseeing compliance with GCP standards ...
- Strong knowledge of pharmaceutical research and development processes, clinical trial conduct, and global regulatory environments.
- Demonstrated experience in GxP Quality Assurance.
- Experience conducting audits, authoring audit reports, evaluating findings, and managing CAPA activities is an advantage. (maybe skill but we can keep here)
- Proven ability to lead complex quality initiatives and influence stakeholders across multiple functions and organizational levels.
Skills:
- Excellent problem-solving, risk assessment, negotiation, and decision-making skills.
- Strong organizational, communication, leadership, and team-building abilities.
- Experience managing multiple projects, priorities, timelines, and competing business needs.
- Ability to establish and maintain effective working relationships with customers, regulators, vendors, and internal stakeholders.
- Proficiency with Microsoft Office applications and quality management systems.
But note that "Experience conducting audits..." could be considered a skill; we could keep it in Skills. Let's move it to Skills to avoid duplication.
Thus Qualifications list: education, years, GCP experience, knowledge of R&D, GxP QA experience, proven ability to lead complex quality initiatives.
Skills list: problem-solving etc., organizational/communication/leadership/team-building, managing multiple projects, relationships, proficiency with MS Office and QMS.
Now Benefits: we have "range of health and welfare and/or other benefits." We'll put that in Benefits section as a .
Pay: we have base pay range and note about variation. We'll put in Pay section.
Schedule: mention of schedule (full or part-time). We'll put in Schedule section.
Now ensure we don't include boilerplate like EEO, fraud warning, etc. Also remove "Learn more at https://jobs.iqvia.com" etc. Also remove "IQVIA is a leading global provider..." paragraph (company description) - that's not substantive to the role? It's about company; maybe we can keep as part of About the role? It's not required but could be considered boilerplate. The instruction: Remove cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate, duplicated lines, and application instructions. The company description might be considered not essential but could be kept? It's not a legal boilerplate; it's a description of the company. Might be okay to keep but could be considered filler. The instruction says preserve ALL substantive information; does company description count as substantive? It's not about the role. I'd lean to omit it as it's not directly about the role. The "About the role" section we already have from Job Overview; we can omit the company description.
Thus final HTML:
About the role
... (the job overview paragraph)
Responsibilities
...
Qualifications
...
Skills
...
Benefits
Range of health and welfare and/or other benefits may be offered.
Pay
The potential base pay range for this role, when annualized
for prose. We must not include any markdown fences. Just raw HTML. Let's structure:
About the role
Provide strategic quality leadership and oversight across assigned Quality Assurance (QA) programs, with a strong focus on clinical research, clinical operations, pharmaceutical development, and GxP-regulated activities. Influence quality outcomes across multiple functional areas, business units, and customer engagements through expert guidance, risk-based decision making, and oversight of quality systems and compliance programs. Lead and coordinate QA initiatives supporting customer accounts, clinical and functional operations, audit and inspection readiness programs, and quality management systems at a regional and/or global level. Partner with stakeholders to assess and promote compliance with applicable regulatory requirements, industry guidelines, and company procedures while driving continuous improvement, risk mitigation, patient safety, and operational excellence. This position is best suited for candidates with substantial Clinical Quality Assurance (CQA), GCP, GxP, pharmaceutical, biotechnology, CRO, healthcare, or clinical research experience. While experience supporting technology-enabled quality systems is valuable, candidates with a predominantly IT Quality Assurance background and limited exposure to regulated clinical environments may not possess the preferred qualifications for this role.
Responsibilities
- Serve as the primary QA liaison for assigned customers, sponsors, clinical operations groups, and internal functional areas.
- Provide Quality Assurance oversight and guidance of quality issues, deviations, CAPAs, risk assessments, and compliance initiatives.
- Serve as a subject matter expert in GCP, GxP, ICH guidelines, clinical trial regulations, and pharmaceutical quality requirements.
- Provide guidance, interpretation, training, and consultation regarding regulations, industry standards, corporate policies, and quality expectations to clinical and operational teams.
- Support inspection readiness activities and support responses to regulatory authority inspections, sponsor audits, and customer audits.
- Assist in the enhancement of Quality Assurance policies, procedures, and risk management programs by providing recommendations to regional and global QA leadership.
- Author, review, and maintain Quality Assurance Standard Operating Procedures (SOPs) and serve as a representative on global quality governance initiatives, if assigned.
- Support customer audits and regulatory inspections and support the development, implementation, and verification of corrective and preventive action (CAPA) plans.
- Support documentation, investigation, reporting, and resolution of compliance-related issues.
- Support Quality Management with proposal reviews, quality strategy development, and quality metric reporting.
- Analyze audit trends, compliance metrics, root causes, and quality indicators to identify opportunities for process improvement and risk reduction.
- Lead or participate in cross-functional quality improvement initiatives and strategic projects.
- Mentor, develop, and manage QA personnel while fostering a culture of quality, compliance, accountability, and continuous improvement.
- Promote patient safety, data integrity, regulatory compliance, and quality excellence throughout the organization.
Qualifications
- Bachelor's degree in Life Sciences, Nursing, Pharmacy, Healthcare Administration, Biology, Chemistry, or related scientific discipline, or equivalent combination of education and experience preferred
- Minimum of 10 years of Quality Assurance experience within pharmaceutical, biotechnology, CRO, medical device, healthcare, or clinical research environments.
- Extensive experience interpreting, applying, and overseeing compliance with Good Clinical Practice (GCP) standards within a clinical research environment.
- Strong knowledge of pharmaceutical research and development processes, clinical trial conduct, and global regulatory environments.
- Demonstrated experience in GxP Quality Assurance.
- Experience conducting audits, authoring audit reports, evaluating findings, and managing CAPA activities is an advantage.
- Proven ability to lead complex quality initiatives and influence stakeholders across multiple functions and organizational levels.
- Excellent problem-solving, risk assessment, negotiation, and decision-making skills.
- Strong organizational, communication, leadership, and team-building abilities.
- Experience managing multiple projects, priorities, timelines, and competing business needs.
- Ability to establish and maintain effective working relationships with customers, regulators, vendors, and internal stakeholders.
- Proficiency with Microsoft Office applications and quality management systems.
. Pay: we have base pay range and note about variation. We'll put in Pay section. Schedule: mention of schedule (full or part-time). We'll put in Schedule section. Now ensure we don't include boilerplate like EEO, fraud warning, etc. Also remove "Learn more at https://jobs.iqvia.com" etc. Also remove "IQVIA is a leading global provider..." paragraph (company description) - that's not substantive to the role? It's about company; maybe we can keep as part of About the role? It's not required but could be considered boilerplate. The instruction: Remove cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate, duplicated lines, and application instructions. The company description might be considered not essential but could be kept? It's not a legal boilerplate; it's a description of the company. Might be okay to keep but could be considered filler. The instruction says preserve ALL substantive information; does company description count as substantive? It's not about the role. I'd lean to omit it as it's not directly about the role. The "About the role" section we already have from Job Overview; we can omit the company description. Thus final HTML:
About the role
... (the job overview paragraph)
Responsibilities
- ...
Qualifications
- ...
Skills
- ...
Benefits
Range of health and welfare and/or other benefits may be offered.
Pay
The potential base pay range for this role, when annualized