What are the responsibilities and job description for the Head, PV and Regulatory QA position at CSL Seqirus?
Entity: CSL Seqirus
Job Category: Quality
Job Family: Quality Assurance
Job Type: Full Time
Location: Waltham, Massachusetts, United States
Employer Reference: R-274196
Job Description
The Head of Pharmacovigilance and Regulatory Quality Assurance leads the global quality and compliance function for our pharmacovigilance system. You are the independent quality authority ensuring that our end-to-end PV processes across clinical safety, regulatory affairs, and medical affairs remain compliant with global regulations, ICH guidelines, and company standards. Your role bridges strategic oversight with hands on operational leadership: you design the audit strategy and governance framework that keeps the system fit for purpose, but you also own the day-to-day quality assurance of how PV actually works across the business.
You will direct both the strategic evolution of the PVRQA function and its operational delivery. This means setting the long term compliance roadmap while simultaneously managing inspections, deviation management, and the practical quality controls that keep the system sound. You partner with senior leadership on strategic direction, but you're equally engaged in the details that matter—ensuring SOPs are fit for purpose, CAPA workflows are rigorous, and systems are inspection-ready.
The Role
You will direct the strategic development of the Global PVRQA function, supporting both the global R&D business and regional affiliates. Your focus is on three core pillars: Strategic Governance, Operational Excellence, and Regulatory Intelligence.
Key Accountabilities:
- Strategic Leadership: Harmonize processes within Global PVRQA and across other GxP areas. Contribute to the larger strategic vision of Global R&D Quality and interact with the Leadership Team to ensure continuous alignment.
- Audit Strategy: Own the long-term, risk-based audit strategy aligned with GVP Module IV; deliver annual internal and external audit programs covering global systems, affiliates, and 3rd party vendors.
- Inspection & Regulatory Management: Lead the preparation, conduct, and response phases for PV health authority inspections and 3rd party audits.
- System Oversight: Monitor PV system health through oversight of deviation management, CAPA, change management, and performance reporting (KPIs).
- Cross-Functional Expertise: Provide GVP consultancy and cross-GxP expertise (GCP, GDP, GCLP) to ensure coordination across functional areas, including Commercial and Clinical Development.
- Operational Management: Oversight of PV IT systems, procedural quality assurance (SOPs), and third-party/vendor management.
- Resource Stewardship: Direct budget development and resource allocation by strategically assessing workload and coordinating consultant activities.
- Continuous Improvement: Monitor global regulatory trends and methodologies to implement improvement initiatives in response to the evolving landscape.
Your Profile
The successful candidate will be a high-calibre Quality Assurance professional with the executive presence to influence global cross-functional teams and the technical depth to safeguard our Pharmacovigilance system.
Qualifications & Experience:
- Education: Undergraduate degree (BA/BS) in a Scientific or Life Sciences discipline; an advanced degree is preferred.
- Industry Tenure: 10 years of pharmaceutical industry experience specifically within Quality Assurance.
- Leadership Track Record: Proven experience in a senior leadership capacity with deep knowledge of GVP/GCP regulations and international pharmacovigilance guidelines.
- Technical Mastery: Extensive understanding of end-to-end pharmacovigilance processes, including Deviation/CAPA management and the conduct of clinical research.
- Global Perspective: Experience working within global, cross-functional teams and managing complex regulatory interactions.
Leadership Attributes:
- Strategic Acumen: The ability to quickly analyze complex circumstances and drive appropriate decisions and actions.
- Communication & Influence: Excellent communication, negotiation, and influencing skills across all levels of the business.
- Operational Rigor: Strong organizational skills with a focus on customer service and the ability to manage complex budgets and resourcing plans.
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.
To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.
Our Benefits
For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.
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.
To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging
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.