Lead Quality Dossier Program Auditor - Hybrid, Chicago

About the role

The Lead Quality Dossier Program Auditor role supports the Quality Dossier Program audit process by planning and conducting audits required by the Quality Dossier Program. This includes effectively communicating and interacting with business partners, e.g., Medical Writing; Regulatory Affairs; Development Sciences, etc., during the audit process and managing other aspects of the audit program, including maintaining the audit schedule, reporting metrics, presenting to Senior Leadership as needed.

Responsibilities

• Plan and conduct audits required by the Quality Dossier Program. Audits may be of clinical documents, pre-clinical documents, CMC documents, etc.
• Perform peer reviews of document audits.
• Review audit responses for adequacy, consistency, and compliance
• Maintain the audit schedule
• Represent RD QA for Dossier Program related meetings/activities/functions as needed.
• Recommend plan of action for satisfactory resolution of quality and regulatory compliance issues
• Identify and resolve problems through effective interpersonal skills.
• Work independently as well as part of a team
• Maintain effective communication of program related information.

Qualifications & Requirements

• Bachelor's degree preferable in a physical science, life science, pharmacy, engineering, or equivalent experience required.
• 5+ years' experience in the Medical Device or Pharmaceutical industry,
• Experience in Quality Assurance or Regulatory Affairs (preferred)
• Quality Assurance auditing experience (preferred)
• Planning and conducting audits required by the Quality Dossier Program
• Effectively communicating and interacting with business partners, e.g., Medical Writing; Regulatory Affairs; Development Sciences, etc., during the audit process.
• Coordinating the review and tracking of audit responses and associated tasks across multiple dossier programs.
• Managing other aspects of the audit program, including maintaining the audit schedule, reporting metrics, presenting to Senior Leadership as needed.
• Escalating potential quality issues to management
• Assist in the management of Due Diligence and Post-Closure Quality Assessment activities in support of projects across one or more aspect of the business.
• Assist in the coordination, review, and tracking of RDQA activities needed to complete Due Diligence and Post-Closure Quality assessments.

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.