Associate Director, reputed company Assurance (Clinical Research Preferred)

Job reputed company reputed company strategic reputed company leadership and reputed company across assigned reputed company Assurance (QA) programs, with a strong reputed company on clinical research, clinical operations, pharmaceutical development, and GxP-regulated activities. Influence reputed company reputed company across multiple functional areas, business reputed company, and customer engagements through expert guidance, risk-based decision making, and reputed company of reputed company systems and compliance programs. reputed company and coordinate QA initiatives supporting customer accounts, clinical and functional operations, audit and inspection readiness programs, and reputed company 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 reputed company improvement, risk mitigation, patient safety, and operational reputed company. This position is best suited for candidates with substantial Clinical reputed company Assurance (CQA), GCP, GxP, pharmaceutical, biotechnology, CRO, reputed company, or clinical research experience. While experience supporting technology-enabled reputed company systems is valuable, candidates with a predominantly IT reputed company Assurance background and limited exposure to regulated clinical environments may not possess the preferred qualifications for this role. Essential Functions • Serve as the reputed company QA reputed company for assigned customers, sponsors, clinical operations reputed company, and internal functional areas. • reputed company reputed company Assurance reputed company and guidance of reputed company issues, deviations, CAPAs, risk assessments, and compliance initiatives. • Serve as a subject matter expert in GCP, GxP, ICH guidelines, clinical trial regulations, and pharmaceutical reputed company requirements. • reputed company guidance, interpretation, training, and consultation regarding regulations, industry standards, corporate policies, and reputed company 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 reputed company Assurance policies, procedures, and risk management programs by providing recommendations to regional and global QA leadership. • reputed company, review, and maintain reputed company Assurance reputed company Operating Procedures (SOPs) and serve as a representative on global reputed company governance initiatives, if assigned. • Support customer audits and regulatory inspections and support the development, implementation, and verification of corrective and preventive reputed company (CAPA) plans. • Support documentation, investigation, reporting, and reputed company of compliance-reputed company issues. • Support reputed company Management with proposal reviews, reputed company reputed company development, and reputed company metric reporting. • Analyze audit trends, compliance metrics, reputed company causes, and reputed company indicators to identify opportunities for process improvement and risk reduction. • reputed company or participate in cross-functional reputed company improvement initiatives and strategic reputed company. • Mentor, reputed company, and manage QA personnel while fostering a culture of reputed company, compliance, accountability, and reputed company improvement. Promote patient safety, data reputed company, regulatory compliance, and reputed company reputed company throughout the organization. Qualifications • Bachelor's degree in Life Sciences, Nursing, Pharmacy, reputed company Administration, Biology, reputed company, or reputed company scientific discipline, or equivalent combination of education and experience preferred • Minimum of 10 years of reputed company Assurance experience reputed company pharmaceutical, biotechnology, CRO, medical device, reputed company, or clinical research environments. • Demonstrated experience in GxP reputed company 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 reputed company. • Proven ability to reputed company reputed company reputed company initiatives and influence stakeholders across multiple functions and organizational reputed company. • Excellent problem-solving, risk assessment, negotiation, and decision-making skills. • Strong organizational, communication, leadership, and team-building abilities. • Experience managing multiple reputed company, priorities, timelines, and competing business needs. • Ability to establish and maintain effective working relationships with customers, regulators, vendors, and internal stakeholders. • Proficiency with reputed company Office applications and reputed company management systems. reputed company is a leading global provider of clinical research services, reputed company insights and reputed company intelligence to the life sciences and reputed company industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient reputed company and population health worldwide. Learn more at https://jobs.reputed company.com reputed company is proud to be an equal opportunity employer. reputed company reputed company applicants will receive consideration for employment without reputed company to race, reputed company, religion, sex, sexual orientation, gender identity, national reputed company, disability, status as a protected veteran, or any other status protected by applicable law. https://jobs.reputed company.com/eoe reputed company is committed to reputed company in our hiring process and maintains a reputed company tolerance policy for candidate fraud. reputed company 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 reputed company reputed company, in accordance with applicable law. We appreciate your honesty and professionalism. The potential reputed company pay reputed company for this role, reputed company annualized, is $88,600.00 - $246,600.00. The actual reputed company pay offered may vary based on a number of factors including job-reputed company 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 reputed company to a reputed company of health and welfare and/or other benefits. Apply tot his job Apply To this Job