Sr. Manager, Clinical QA

Description

• Supervise direct reports to ensure audits are executed within the agreed upon timelines, performance goals are met along with development needs are identified and supported.
• Participate in various development teams to ensure provide risk-based options of clinical development compliance risk are identified to ensure GCP quality and compliance by acting as a source of advice and guidance.
• Support the development and management of the CQA audit strategy, utilizing a risk-based methodology.
• Contribute to the development, maintenance and continuous improvement of departmental processes and procedures and support the implementation and continuous improvement of the GCP and PV Systems.
• Participate in various development teams to ensure provide risk-based options of clinical development compliance risk are identified to ensure GCP quality and compliance by acting as a source of advice and guidance.
• Represent the organization in internal presentations on quality issues, initiatives and projects.
• Co-host FDA, regulatory authorities and external auditors covering inspections and audits related to GCP and PV.
• Ensures appropriate processes and procedures are in place to support development activities.

• A minimum of 10 years experience in the Biotech/Pharmaceutical Industry in GCP compliance, clinical monitoring or equivalent with 5-8 years in quality.
• Regulatory compliance auditing, leading projects and team(s) experience preferred.
• Experience in support of FDA, regulatory authority inspections and external audits.
• Experience leading projects and teams in a matrix organizational environment represented by a diverse set of personalities required. Previous managerial experience preferred.
• Ability to translate technical knowledge into guidance appropriate for audiences with deferring degrees of experience.
• Requires a BA/BS or RN or PA. A healthcare background and/or an advance degree preferred.