Role 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.
What You Will Do
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.
Why It Might Be a Fit
This position is best suited for candidates with substantial Clinical Quality Assurance (CQA), GCP, GxP, pharmaceutical, biotechnology, CRO, healthcare, or clinical research experience.
Requirements
- Bachelor's degree in Life Sciences, Nursing, Pharmacy, Healthcare Administration, Biology, Chemistry, or related scientific discipline, or equivalent combination of education and experience
- 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
- 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
Benefits
- Potential base pay range of $88,600.00 - $246,600.00
- Incentive plans, bonuses, and/or other forms of compensation
- Range of health and welfare and/or other benefits
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