The Manager, Process Excellence within Regulatory Affairs is responsible for managing key process excellence and issue management activities that support compliant, efficient, and inspection-ready Regulatory Affairs operations. This role oversees the Regulatory Affairs Issue and CAPA Management system (RAIM), triages issue records, escalates issues to Exception Reports when warranted, and partners cross-functionally to drive process improvements. Through collaboration with functional and cross-functional stakeholders, the position also supports inspection readiness and audit/inspection response activities, and management of change plans for legacy company integrations into Regulatory Affairs business processes.
location: North Chicago, Illinois
job type: Contract
salary: $60.00 - 68.34 per hour
work hours: 9 to 5
education: Bachelors
responsibilities:
- Manage the Regulatory Affairs Issue and CAPA Management system (RAIM) to ensure records are appropriately logged, tracked, and resolved.
- Triage RAIM issue records to determine severity, compliance impact, and necessary next steps.
- Escalate issue records to Exception Reports based on risk and process significance.
- Project manage Exception Reports in partnership with cross-functional stakeholders to identify root causes and drive corrective actions.
- Collaborate with Regulatory leaders, Business Process Owners, and Quality teams to ensure timely issue management.
- Support internal/external audit and inspection readiness, including documentation coordination and response support.
- Manage legacy integrations for business processes through structured change plans in OneTrack.
qualifications:
Required:
- Bachelor's degree in life sciences (pharmacy, biology, chemistry, pharmacology, or related field).
- 5+ years of experience in regulatory, pharmaceutical, or medical device environments.
- Hands-on experience managing issue/CAPA systems, exception reporting, or compliance investigation workflows.
- Strong organizational, analytical, communication, facilitation, and stakeholder management abilities.
- Proven ability to manage multiple priorities and influence without authority in a matrixed environment.
- Relevant advanced degree in science or business, or industry certifications.
- Background in Regulatory Affairs, Quality, process excellence, or business process management.
- Experience supporting audit and inspection readiness in a regulated environment.
- Proficiency managing process integrations using change platforms like OneTrack.
skills: Regulatory Affairs Operations, Corrective and Preventive Actions (CAPA), Regulatory Information Management (RIM)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).
This posting is open for thirty (30) days.
