Senior Compliance Auditor

About CSL

With operations in 35+ nations and ~ 22,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment.

CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma , one of the world's largest collectors of human plasma, which is used to create CSL's therapies. Seqirus is the second largest influenza vaccine company in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally.

We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team!

Job Description

The Senior Compliance Auditor independently conducts assigned internal audits and evaluations for compliance with US, foreign regulatory requirements, and CSL Behring policies and procedures. This position continuously monitors, communicates, and maintains highest level of awareness with current industry standards emerging international regulations / guidance and FDA Regulations to ensure proactive determination of compliance risk.

Main Responsibilities

1 Develop audit plans, lead internal quality system and process audits, prepare audit reports, and communicate findings

2 Assist in the development of the internal audit schedule

3 Primary support of regulatory agency audits utilizing expertise and audit intelligence during audits

• Host external third party audits
• Assist in audit response activities
• Maintain evidence books
• Complete effectiveness check activities

4 Leads audits, site preparation assessments, and regulatory readiness activities and provide compliance guidance to site personnel

5 Facilitate review of regulatory authority regulations/guidance, identify potential gaps/opportunities for improvement, work with departments to mitigate gaps. Provides review of updates related to North American regulations (i.e. FDA, Canada GMPs, etc.) to global QA

6 Prepare and maintain Quality Agreements between CSL entities

7 Participate in site product recall activities. Lead recall activities as requested

8 Develop and maintain technical and functional expertise in manufacturing processes and associated quality systems

9 Demonstrate an understanding of performance improvement principles using Lean / Six Sigma tools and techniques to identify opportunities for improvement supporting CSL Behring's continuous improvement initiatives

10 Perform independent review of Regulatory Submissions

11 Coordinate and chair the cross-functional Material Review Request evaluation and risk analysis meetings and report "high risk" materials to CSL Behring's Sr. Management Team

12 Report department responsible KPIs for monthly management review. Act as delegate for department management during monthly review meetings, as requested

13 Provide supplier assessment support, as requested, to Global Supplier Quality

14 Completes any other duties/responsibilities assigned by senior management.

Qualification Requirements
Education:

• Bachelor's degree in a Technical or Scientific field strongly preferred
• Professional quality certification (i.e. ISO) preferred
• Audit certification (i.e. ASQ) preferred

Experience:

• Proven experience in regulatory authority guidances such as FDA (specifically CFR 211, 600s, 820, Combination Product guidance), EudraLex Volume 4 and related annexes), China FDA Good Manufacturing Practice for Drugs, PIC/s and other international regulatory authority regulations.
• Five (5) years' experience in a GMP regulated facility (specific to the guidance referenced above)
• Two (2) years' in a quality compliance auditing role (internal, external, supplier or combination)
• Relevant experience working with the regulations applicable to the industry

Competencies:

• Communicates Effectively
• Global Perspective
• Values Differences
• Manages Ambiguity
• Instills Trust
• Organizational Savvy
• Manages Conflict

CSL is introducing a new Career Framework, which will provide a common, global infrastructure for managing jobs and serve as a foundation for future career development and competitive rewards. Certain components of this job description, including Title and Level are subject to change relative to applicable local laws. Your Talent Acquisition Consultant will discuss the pending changes with you.