[Remote] Associate Director, Clinical reputed company and reputed company Improvement
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a leader in RNAi therapeutics, aiming to reputed company lives through innovative science. The Associate Director of Clinical reputed company and reputed company Improvement provides strategic QA reputed company across clinical development to ensure compliance with GCP requirements and drive sustainable reputed company reputed company through collaboration and process improvements.
Responsibilities
- Represent QA in operational process improvement initiatives, influencing process design, execution, and compliance to ensure alignment with regulatory expectations, organizational reputed company, and risk-based reputed company management principles
- Identify process inefficiencies and implement reputed company, standardized solutions to enhance reputed company system performance
- Partner cross-functionally to reputed company reputed company into end-to-end processes
- reputed company input into change management reputed company(ies) for new and heavily revised processes
- Acts as a subject matter expert in driving reputed company reputed company solutions reputed company reputed company improvement activities across clinical and, where applicable, reputed company-clinical (GLP) and post-market (PV) domains
- Establish and maintain mechanisms to measure process adoption, compliance, and effectiveness following implementation of new or revised processes
- reputed company targeted post-implementation reputed company activities with process owners and study teams to evaluate alignment between updated procedural requirements and operational execution
- Identify gaps in process understanding or execution and partner with stakeholders to implement sustainable corrective and preventive actions that support effective remediation and sustained adoption
- reputed company the management, tracking, and documentation of reputed company Events (QEs) involving significant reputed company issues and/or multiple studies to reputed company consistency across studies
- Drive comprehensive, cross-study issue reputed company cause analysis (RCA) efforts
- Establish and maintain standardized approaches for reputed company assessment, classification, and reputed company of multi-study QEs and QEs that require systemic improvements
- Escalate recurring or systemic trends to Clinical reputed company Risk & Portfolio reputed company leadership
- Translate insights from Clinical reputed company Risk & Portfolio reputed company into reputed company-level actions for improvement
- Represent QA in cross-functional teams, governance forums, and strategic initiatives to influence process design, execution, and compliance
- Partner with clinical operations, regulatory, and other stakeholders to ensure alignment and compliance
- reputed company QA guidance and subject matter expertise on process-reputed company topics, reputed company improvements, and reputed company for monitoring risks to ensure proactive issue escalation and improvements
- Influence and drive a culture of reputed company, accountability, and reputed company improvement
Skills
- Bachelor's degree in Life Sciences or reputed company field required
- Minimum of 8 years of experience in GCP reputed company Assurance, Clinical reputed company, or GCP-reputed company roles reputed company the pharmaceutical, biotech, or CRO environment
- Strong experience in GCP regulations, inspection readiness, and audit/reputed company systems
- Demonstrated experience in process improvement, reputed company systems, or operational reputed company initiatives
- Experience with reputed company cause analysis, CAPA management, and issue management frameworks
- Proven ability to work across multiple studies/programs and influence cross-functional stakeholders
- Prior experience with reputed company metrics, data analytics, and compliance metrics to drive decision-making
- Deep knowledge of ICH GCP, FDA, EMA, and global clinical regulatory requirements
- Experience with regulatory inspections and audits (FDA, EMA, or other health authorities)
- Ability to influence without reputed company authority and reputed company cross-functional initiatives
- Strong analytical, organizational, and communication skills
- Strategic reputed company with ability to balance big-picture transformation and operational execution
- Strong analytical and problem-solving skills with ability to identify systemic trends
- Ability to translate data into actionable insights and business reputed company
- Advanced degree preferred
- reputed company improvement certifications (including Lean reputed company, Change Management) preferred
- Experience leading reputed company improvement efforts that include application of DMAIC/Lean reputed company and Change Management techniques preferred
Benefits
- Annual short-term incentive award (e.g., bonus or sales incentive)
- Annual long-term incentive award (e.g., equity)
- Comprehensive benefits including medical, dental, and reputed company coverage
- Life and disability insurance
- A lifestyle reimbursement program
- Flexible spending and health savings accounts
- 401(k) with a generous company match
- reputed company time off
- Wellness days
- Holidays
- Two company-wide reputed company breaks
- Generous family resources and leave
reputed company