Senior Manager, Regulatory Affairs Process Excellence

BioSpace; North Chicago (IL); Hybrid; USD 140.000 - 190.000; Vollzeit

Zusammenfassung

AbbVie is seeking a Senior Manager, Process Excellence within Regulatory Affairs to lead issue management, CAPA handling, and governance across legacy integrations. You will coordinate with Quality, Regulatory Leaders, and other functions to ensure inspection readiness and effective change management.

The role is based at our Lake County, IL headquarters with a hybrid work schedule. The ideal candidate has 8+ years in regulatory/pharma or device environments, strong organizational and

Qualifikationen

• Bachelor's degree in life sciences required.
• 8+ years of regulatory, pharmaceutical or device experience.
• Experience in issue/CAPA systems and audit readiness.

Aufgaben

• Manage RAIM to log, assess, track, and resolve issues.
• Triage RAIM records by severity and impact.
• Escalate records to Exception Reports as needed.
• Project manage Exception Reports with cross-functional teams.
• Collaborate with Regulatory Affairs and Quality to ensure timely issue management.
• Support audits and inspections and respond as needed.
• Lead change plans for legacy integrations in Regulatory Affairs.
• Maintain process documentation and change plans in governance alignment.
• Communicate and adopt process changes with stakeholders.
• Hybrid work schedule: 3 days in office, 2 days remote at Lake County, IL headquarters.

Kenntnisse

Regulatory affairs

CAPA management

Issue management

Stakeholder management

Audit support

Change management

Cross-functional collaboration

Documentation

Ausbildung

Bachelor's degree in life sciences

Tools

RAIM system

OneTrack

Jobbeschreibung

Company Description

About AbbVie AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Job Description

The Senior 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.

Responsibilities

• Manage the Regulatory Affairs Issue and CAPA Management system (RAIM) to ensure issues are appropriately logged, assessed, tracked, and resolved
• Triage RAIM issue records to determine severity, impact, and appropriate next steps
• Escalate issue records to Exception Reports when needed based on risk, compliance impact, or process significance
• Project manage Exception Reports in partnership with cross‑functional stakeholders to identify root causes, drive corrective actions, and improve AbbVie processes
• Collaborate with Regulatory Affairs leaders, Business Process Owners, Quality, and other functions to ensure issue management activities are timely, well‑coordinated, and effective
• May provide support during internal and external audits and inspections, including coordination of documentation, issue follow‑up, and response support as needed
• Manage multiple legacy company integrations for Regulatory Affairs business processes through change plans in OneTrack
• Ensure process documentation, issue records, and change plans are maintained accurately and in alignment with applicable governance expectations
• Partner with stakeholders to support effective communication, implementation, and adoption of process changes.
• This role will work a hybrid work schedule (3 days in office, 2 days remotely) from our Lake County, IL AbbVie headquarters.
• Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required

Qualifications

• Required Education: Bachelor's degree in life sciences (pharmacy, biology, chemistry, pharmacology or related subject).
• Preferred Education: Relevant advanced degree in science or business is preferred. Certification a plus
• Required Experience: 8+ years of regulatory, pharmaceutical or device experience.
• Experience in Regulatory Affairs, Quality, process excellence, business process management, or related roles is preferred
• Experience managing issue/CAPA systems, exception reporting, or comparable compliance and investigation workflows
• Experience supporting audit and inspection readiness in a regulated environment
• Strong organizational, analytical, communication, facilitation, and stakeholder management skills
• Ability to manage multiple priorities and work effectively across functions and levels
• Ability to influence without direct authority and work in a matrixed environment

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:

The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.

We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.

This job is eligible to participate in our long‑term incentive programs.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: https://www.abbvie.com/join-us/reasonable-accommodations.html