主任级，质量保证（优先临床研究）
Associate Director, Quality Assurance (Clinical Research Preferred)
职位名称：质量保证高级经理（优先考虑临床研究背景）
工作地点：美国宾夕法尼亚州韦恩
工作地点类型：远程办公
雇佣类型：全职
职位级别：
职位概述
在指定的质量保证（QA）项目中提供战略性的质量领导和监督，重点在于临床研究、临床运营、药品开发和GxP规范活动。通过专家指导、基于风险的决策以及对质量体系和合规项目的监督，影响多个职能领域、业务单元和客户合作中的质量成果。
领导并协调支持客户账户、临床和职能运营、审计和检查准备项目以及区域和/或全球范围内的质量管理体系的QA计划。与相关方合作，评估并推动符合适用的监管要求、行业指南和公司程序的合规性，同时推动持续改进、风险缓解、患者安全和运营卓越。
该职位最适合具有丰富临床质量保证（CQA）、GCP、GxP、药品、生物技术、CRO、医疗保健或临床研究经验的候选人。虽然具备支持技术驱动的质量体系的经验是有价值的，但以IT质量保证为主且缺乏受监管临床环境经验的候选人可能不符合该职位的首选资格。
主要职责
- 作为指定客户、发起方、临床运营团队和内部职能领域的主要QA联络人。
- 提供质量保证监督和指导，处理质量问题、偏差、纠正和预防措施（CAPA）、风险评估和合规项目。
- 在GCP、GxP、ICH指南、临床试验法规和药品质量要求方面成为主题专家。
- 向临床和运营团队提供有关法规、行业标准、公司政策和质量期望的指导、解释、培训和咨询。
- 支持检查准备活动，并协助应对监管机构的检查、发起方审计和客户审计。
- 通过向区域和全球QA领导层提供建议，协助提升质量保证政策、程序和风险管理项目。
- 编写、审核和维护
查看英文原文
Job Title: Associate Director, Quality Assurance (Clinical Research Preferred)
Job Location: Wayne, Pennsylvania, United States of America
Job Location Type: Remote
Job Contract Type: Full-time
Job Seniority Level:
Job Overview
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.
Essential Functions
- 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.
- Demonstrated experience in GxP Quality Assurance,
- Strong knowledge of pharmaceutical research and development processes, clinical trial conduct, and global regulatory environments.
- 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.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at
IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law.
IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.
The potential base pay range for this role, when annualized, is $88,600.00 - $246,600.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.
This job is curated by Lifelancer.
Lifelancer is a talent-hiring platform in Life Sciences, Pharma and IT. The platform connects talent with opportunities in pharma, biotech, health sciences, healthtech and IT domains.
Please apply via Lifelancer platform to get connected to the application page and to find similar roles.
Originally posted on Himalayas