Manager, GMP Inspection Management

About the role

The Manager, GMP Inspection Management role at RayzeBio is a critical position within the Quality Operations team. This role is responsible for managing activities for Site Quality Operations in accordance with RayzeBio policies, standards, procedures, and global cGMPs. Key responsibilities include leading site inspection readiness efforts, developing and managing the Inspection Readiness annual plan, participating in corporate and health authority inspections, and conducting audits.

Responsibilities

• Leads site inspection readiness efforts about preparing the Indianapolis site for health authority inspections and internal corporate audits.
• Develops and manages the Inspection Readiness annual plan, including identification of anticipated inspections.
• Participates as a core team member in any corporate or health authority inspections and leads cross-functional teams to develop responses, tracking commitments to completion.
• Responsible for RayzeBio Self-Inspection Program.
• May conduct audits of RayzeBio departments relative to RayzeBio policies and procedures as well as the relevant Health Authority requirements.
• Leads Regulatory Surveillance activities, including identifying impacted functions, driving impact assessments, and proactive action plans.
• Provides compliance expertise and guidance to the site on applicable regulatory, cGMP, and corporate requirements.
• Supports regulatory agency correspondence and filing submission activities.
• Leads Fact Finding deliverables for significant events and supports Field Alert Reporting submissions as required.
• Leads APQR document coordination and authoring support for site.
• Identifies and reports discrepancies from required work practices or procedures to management.
• Makes sound decisions by exercising judgment within generally defined practices and policies and applies appropriate notification to management as appropriate.
• Provides oversight to identify and implement changes that lead to realization of long-term department and company goals.
• Other QA specific responsibilities as assigned by QA management.

Requirements

• At minimum, a bachelor's degree in engineering or a life or physical science related field (including biology, biochemistry, chemistry).
• Minimum 5-7 years of work experience in Quality Assurance and minimum 4 years of direct QA experience in leading/hosting/conducting GMP audits/inspections.
• Strong background and demonstrated effectiveness in quality assurance operation and compliance of clinical/commercial manufacturing.
• Knowledge of US, EU and rest-of-world cGMP regulations and guidance.
• Knowledge and proven experience in hosting/facilitating FDA, EMA, or other regulatory authority inspections.
• Demonstrated leadership, interpersonal, communication, and motivation skills.
• Excellent writing and oral communication skills are required.
• Previous work responsibility, which required a high degree of attention to detail.
• Well-practiced in exercising sound judgment in decision-making.
• Demonstrated prioritization and organization skills.

Qualifications

• Knowledge of US, EU and rest-of-world cGMP regulations and guidance.
• Knowledge and proven experience in hosting/facilitating FDA, EMA, or other regulatory authority inspections.
• Strong background and demonstrated effectiveness in quality assurance operation and compliance of clinical/commercial manufacturing.
• Leadership, interpersonal, communication, and motivation skills.
• Excellent writing and oral communication skills.
• High degree of attention to detail.
• Sound judgment in decision-making.
• Prioritization and organization skills.

Skills

• Quality Assurance (QA) experience.
• Experience in leading/hosting/conducting GMP audits/inspections.
• Understanding of US, EU and rest-of-world cGMP regulations and guidance.
• Experience in hosting/facilitating FDA, EMA, or other regulatory authority inspections.
• Leadership, interpersonal, communication, and motivation skills.
• Writing and oral communication skills.
• Attention to detail.
• Decision-making and prioritization skills.

Benefits

• Health Coverage: Medical, pharmacy, dental, and vision care.
• Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
• Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
• Paid Time Off: Flexible time off (unlimited, with manager approval), 11 paid national holidays, and 3 optional holidays.