Job OverviewProvide 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.
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.
