Manager, CMO Quality

About CSL Seqirus

CSL Seqirus is one of the world's largest influenza vaccine companies and a global leader in pandemic preparedness. As part of the CSL Group, we operate at the intersection of cutting-edge science and meaningful human impact — protecting millions of lives every year. When you join CSL Seqirus, you join a team where quality is not a department, it's a commitment.

The Opportunity

Reporting to the Global Head of External Quality , the Manager, CMO Quality plays a critical role in ensuring the integrity, compliance, and continuity of our external manufacturing network. You will be the primary quality partner for assigned Contract Manufacturing Organizations (CMOs) — overseeing outsourced production activities including API, Fill/Finish, and Packaging — and serve as the trusted bridge between CSL Seqirus and our global CMO partners.

This is a high-visibility, globally connected role where your decisions directly protect product supply, patient safety, and regulatory standing across multiple markets.

What You'll Do

CMO Relationship & Quality Oversight

• Serve as the primary regional quality interface for assigned CMOs, fostering strong, trust-based partnerships

• Ensure CMO quality systems are aligned with CSL Seqirus standards and applicable regulatory requirements

• Represent CSL Seqirus Quality in Joint Operational Meetings, Business Reviews, and on-site CMO visits

Quality Agreements & Governance

• Draft, negotiate, and maintain CMO Quality Agreements in compliance with FDA, EMA, PIC/S, TGA, and Health Canada regulations

• Oversee day-to-day execution of Quality Agreement commitments including training, recalls, and complaint management

Deviation, CAPA & Change Management

• Review, assess, challenge, and approve CMO deviations and CAPAs to ensure product quality and compliance

• Manage CMO-initiated changes and proactively communicate relevant updates to MAH stakeholders

• Review and approve GMP-controlled documents including SOPs, specifications, and validation reports

Performance Monitoring & Escalation

• Track and report CMO quality performance through globally aligned KPIs

• Identify quality trends and ensure timely corrective actions are implemented

• Escalate critical quality issues to senior stakeholders and drive resolution

Standardization & Continuous Improvement

• Drive harmonization of quality processes across the CMO network (change management, batch record review, complaints, recalls)

• Enhance CMO Quality Maturity and execute Quality Road Maps

Regulatory & Inspection Support

• Support regulatory inspections and audits at CMO sites as needed

• Assess and communicate potential regulatory impacts on CSL Seqirus business

Commercial Readiness & Growth

• Support Tech Transfer, product launches, and regulatory submissions for new CMO projects

• Act as Quality SME in cross-functional commercial readiness teams

What You'll Bring

Education

• Bachelor's degree (or higher) in Pharmacy, Chemistry, Biology, Biochemistry, or a related scientific discipline

Experience

• Minimum 5 years of experience in a GxP environment within the pharmaceutical, biotech, or regulated industry

• Demonstrated knowledge of FDA, PIC/S, EU GMP, TGA, and Health Canada regulatory frameworks

• Prior experience in CMO / third-party quality management highly preferred

• Proven ability to work effectively in a global matrix organization

Skills & Competencies

• Strong quality system knowledge — internal and external manufacturing environments

• Excellent organizational skills with the ability to manage multiple priorities across time zones

• High cross-cultural sensitivity and interpersonal effectiveness

• Managerial courage — able to hold compliance positions under pressure

• Strategic mindset with strong decision-making and risk assessment capabilities

• Outstanding written and verbal communication skills

• Fluency in English and Spanish is required (written and spoken)

What We Offer

• A globally connected role with real impact on product supply and patient safety

• Collaboration with world-class quality professionals across Americas, EMEA, and APAC

• A culture that values integrity, courage, and continuous improvement

• Competitive compensation and benefits aligned with multinational pharma standards

• Approximately 25% travel to CMO sites and CSL Seqirus locations

Our Commitment

CSL Seqirus is committed to building a diverse, equitable, and inclusive workplace. We welcome applicants from all backgrounds and are proud to be an equal opportunity employer.