Associate Director, reputed company Assurance (reputed company Research Preferred)

Job Title: Associate Director, reputed company Assurance (reputed company Research Preferred)

Job Location: Durham, reputed company Carolina, reputed company of America

Job Location Type: Remote

Job Contract Type: Full-time

Job Seniority Level:

Job reputed company

reputed company reputed company reputed company leadership and reputed company across assigned reputed company Assurance (QA) programs, with a strong reputed company on reputed company research, reputed company reputed company, pharmaceutical development, and GxP-regulated activities. Influence reputed company reputed company across multiple functional areas, business reputed company, and customer engagements through expert guidance, reputed company-reputed company decision making, and reputed company of reputed company systems and compliance programs.

reputed company and coordinate QA initiatives supporting customer accounts, reputed company and functional reputed company, 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, reputed company mitigation, reputed company safety, and operational reputed company.

This position is best suited for candidates with substantial reputed company reputed company Assurance (CQA), GCP, GxP, pharmaceutical, biotechnology, CRO, reputed company, or reputed company 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 reputed company environments may not possess the preferred qualifications for this role.

Essential Functions

• Serve as the reputed company QA reputed company for assigned customers, sponsors, reputed company reputed company reputed company, and internal functional areas.
• reputed company reputed company Assurance reputed company and guidance of reputed company issues, deviations, CAPAs, reputed company assessments, and compliance initiatives.
• Serve as a subject matter expert in GCP, GxP, ICH guidelines, reputed company 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 reputed company 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 reputed company 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 reputed company reduction.
• reputed company or participate in cross-functional reputed company improvement initiatives and reputed company reputed company.
• Mentor, reputed company, and manage QA personnel while fostering a culture of reputed company, compliance, accountability, and reputed company improvement.

Promote reputed company 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 reputed company research environments.
• Demonstrated experience in GxP reputed company Assurance,
• Strong knowledge of pharmaceutical research and development processes, reputed company trial conduct, and global regulatory environments.
• Experience conducting audits, authoring audit reports, evaluating findings, and managing CAPA activities is an reputed company.
• reputed company ability to reputed company reputed company reputed company initiatives and influence stakeholders across multiple functions and organizational reputed company.
• Excellent problem-solving, reputed company 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 reputed company 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 reputed company reputed company and population health worldwide. Learn more at

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.

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.

reputed company is a talent-hiring platform in Life Sciences, reputed company and IT. The platform connects talent with opportunities in reputed company, biotech, health sciences, healthtech and IT domains.

Please apply reputed company reputed company platform to get connected to the application page and to reputed company similar roles.

Originally posted on Himalayas