Senior Director - Permanent - New Jersey (Hybrid)
杨贵妃传媒网ygfcmw·(中国)站入口直接进 is seeking a Clinical Quality Lead - Senior Director to lead international clinical quality initiatives and ensure adherence to Good Clinical Practice (GCP) principles and applicable health authority guidelines. This strategic role involves shaping quality frameworks across global clinical programs and driving excellence in clinical research operations.
Primary Responsibilities:
The successful candidate will be responsible for overseeing audits, inspections, and quality systems, while working collaboratively across cross-functional teams to uphold the highest standards of clinical compliance and integrity.
Skills & Requirements:
- Bachelor's degree in Life Sciences, Pharmacy, or a related discipline; an advanced degree is strongly preferred.
- Significant experience in clinical quality assurance, with a strong focus on GCP compliance and oversight of global audits and inspections.
- Professional certification in Quality Assurance (e.g., CQA, RQAP-GCP) is desirable.
- Demonstrated experience with Phase 3 clinical trials and FDA inspections; familiarity with international regulatory environments is a plus.
- Background in hematology-oncology studies and pharmacovigilance quality systems is advantageous.
- In-depth knowledge of ICH GCP guidelines and global regulatory standards, with the ability to apply them effectively in clinical settings.
- Proven track record of leading complex clinical QA initiatives and working collaboratively with global, cross-functional teams.
- Practical, hands-on leadership approach with a strong emphasis on execution and results.
- Exceptional communication skills and meticulous attention to detail.
- Willingness and ability to travel up to 15% as required.
The Senior Director's responsibilities will be:
- Design and execute global quality assurance frameworks and procedures in alignment with GCP standards and applicable regulatory guidelines.
- Manage the Clinical Quality Manual, ensure robust oversight of GCP-compliant vendors and CROs, and deliver key quality metrics to senior leadership.
- Direct end-to-end audit programs covering service providers, clinical trial sites, and electronic systems, including both scheduled and for-cause audits.
- Coordinate inspection readiness initiatives and response plans for both U.S. and global regulatory inspections, including mock audits and compliance preparedness.
- Partner with cross-functional stakeholders to proactively identify compliance risks and implement practical, aligned solutions.
- Lead the management of quality issues, including categorization, escalation protocols, and evaluation of CAPA effectiveness.
- Ensure QA strategies are integrated with clinical development objectives and continuously updated to reflect evolving regulatory requirements.
- Act as the principal point of contact for clinical QA communications with regulatory bodies, external partners, and internal teams.
- Develop and oversee quality assurance systems supporting pharmacovigilance activities.
- Undertake additional responsibilities as required to support departmental and organizational objectives.
Compensation:
- $260 000.00 - $280 000.00 Per Annum
If you are having difficulty in applying or if you have any questions, please contact Josh Godden at j.godden@proclinical.com
If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.
杨贵妃传媒网ygfcmw·(中国)站入口直接进 is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. 杨贵妃传媒网ygfcmw·(中国)站入口直接进 is acting as an Employment Agency in relation to this vacancy.
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