Manager, CMO Quality (Contract Manufacturing Organizations) - CSL Seqirus

CSL; Buenos Aires; Presencial; ARS 181.747.000 - 242.329.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Travel opportunities

Descripción de la vacante

CSL Seqirus seeks a Manager, CMO Quality to ensure integrity and regulatory compliance across outsourced manufacturing networks for APIs, fill/finish, and packaging. You will partner with CMOs and QA teams to manage quality agreements, deviations, CAPAs, and GMP documentation.

The role requires 5+ years in a GxP environment, knowledge of global regulatory standards, and fluency in English and Spanish. Expect ~25% travel and global collaboration across Americas, EMEA, and APAC.

Formación

• Minimum 5 years of experience in a GxP environment within pharma/biotech/regulatory industries.
• Knowledge of FDA, PIC/S, EU GMP, TGA, Health Canada frameworks.

Responsabilidades

• Serve as the primary regional quality interface for assigned CMOs and oversee quality systems.
• Draft, negotiate, and maintain CMO Quality Agreements per global regulations.
• Review and approve deviations, CAPAs, and GMP-controlled documents.
• Track quality performance with KPIs and escalate critical issues.
• Support regulatory inspections, tech transfer, and regulatory submissions.

Conocimientos

GxP experience

Regulatory knowledge

CMO quality

Global matrix

English & Spanish

Educación

Bachelor's degree in Pharmacy or related

Descripción del empleo

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
• 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
• 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.

About CSL Seqirus

CSL Seqirus is part of CSL. As one of the largest influenza vaccine providers in the world, CSL Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. With state-of-the-art production facilities in the U.S., the U.K. and Australia, CSL Seqirus utilizes egg, cell and adjuvant technologies to offer a broad portfolio of differentiated influenza vaccines in more than 20 countries around the world.

You Belong at CSL

At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.

Equal Opportunity Employer

CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement.