Senior Manager, Clinical Quality Assurance.

Summary:

We are seeking a dedicated and experienced Senior Manager, Clinical Quality Assurance, to join our dynamic team. The ideal candidate will have a strong background in quality management within a clinical setting and a passion for maintaining the highest standards of clinical excellence. This role requires an individual who can work with teams to ensure compliance with regulatory requirements and achieve our mission of delivering high-quality healthcare solutions.

Essential Functions:

• Lead global investigations and support teams with CAPA preparation in compliance with applicable regulations/guidelines, customer requirements, Standard Operating Procedures (SOPs) and project specific guidelines/instructions.
• Manage Quality Issues and serious breach investigations.
• Review, approve Investigations, Root Cause Analysis (RCA), Corrective and Preventive Action (CAPA) and Effectiveness Check (EC) plans.
• Track until closure quality events from Quality Issues, Audits, Inspections or during similar QA activities.
• Manage/oversee quality event update in eQMS.
• Plan, schedule, and conduct risk based and For Cause audits of clinical investigators sites, CROs, and other GCP vendors.
• Support regulatory agency inspection readiness activities, including mock inspections, gap assessments, and inspection response coordination.
• Evaluate policies and procedures for compliance with applicable regulations/guidelines and provide recommendations to management for continuous process improvements.
• Support in QA initiatives/projects for quality, process improvements.
• Promotes a quality mindset and quality excellence approach to all activities.
• Understands and interprets regulatory agencies policies and guidance as it pertains to GCP requirements and assists in the implementation of compliant processes at Vaxcyte.

Requirements: 

• BA or BS in related field.
• Minimum of 9 years of experience in Quality Assurance within the clinical or pharmaceutical industry. Other combinations of education and/or experience may be considered.
• Knowledge of QMS system (Veeva preferred).
• GCP QA Certification preferred (RQAP-GCP, or similar).
• Experience across all phases of clinical development.
• Knowledge of applicable FDA regulations and ICH guidelines.
• Proficiency in QA tools and software (Veeva preferred).
• Excellent communication and interpersonal skills, with the ability to work collaboratively with diverse teams.
• Strong analytical and problem-solving skills, with a keen attention to detail.
• Ability to travel up to 15%.