The Manager II, Clinical Quality Assurance role is responsible for clinical quality support and management of the Good Clinical Practice (GCP), Good Laboratory Practice (GLP) and Good Pharmacovigilance Practice (GVP) supplier qualification program. The successful candidate will assist in inspection readiness activities across the company, training and ensuring adherence with current ICH GCP E6 guidance and applicable regulations.
Requirements
- 8 years of experience in clinical
- 5 years of experience within the pharmaceuticals industry
- Bachelor’s Degree in Scientific Field Preferred
- In-depth knowledge of clinical trial related FDA regulations, ICH Guidelines, and experience with international GCP/GLP/GVP regulations and guidelines is desired.
- Extensive knowledge in Risk-Based Management (RBM), global clinical regulations and clinical development.
- Experience with investigations using root cause analysis, corrective and preventive actions (CAPA) and CAPA effectiveness checks.
- In-depth knowledge of auditing planning, principles, techniques and communication skills to clearly and efficiently convey findings and report deficiencies.
- Ability to work closely with both internal and external personnel to increase the level of compliance and cooperation while creating opportunities to improve operations and implementing them effectively to reduce errors.
- Ability to adapt to shifting priorities in a fast‐paced environment.
- Strong computer and organizational skills.
- Strong attention to detail.
- Decision Making - Demonstrates strong decision-making by applying structured analysis to complex challenges, balancing competing priorities and long-term impacts while engaging stakeholders and driving solutions aligned with organizational goals.
- Collaboration and Team Building - Promotes collaboration by aligning diverse teams around shared goals, fostering healthy debate to advance outcomes, and building strong networks that strengthen organizational effectiveness and cross-team learning.
- Outcome Driven - Demonstrates strong outcomes focus by aligning teams around shared priorities, proactively addressing risks and dependencies, and driving cross-functional accountability to sustain progress and deliver results.
Benefits
- health, dental and vision insurance benefits
- generous paid time off
- bonus
- stock equity
- comprehensive benefits
