New · posted Nov 6
argenx · Biotechnology
Associate Director, Pharmacovigilance Quality Management, Global Patient Safety
- Remote, US
- Remote
- Full-time
- Director
The role
PURPOSE OF THE FUNCTION
- The Global Patient Safety (GPS) Pharmacovigilance (PV) QM Lead is responsible for the operational implementation of the Pharmacovigilance Quality Management System (QMS) in a consistent, effective and efficient way within the Global Patient Safety functional area.
- Provide pharmacovigilance (PV) oversight for the management and operational maintenance of third-party contractual obligations.
- This position will also:
- Drive the growth of the GPS Quality Management function.
- Drive & Implement the Comprehensive Training Program.
- Manage GPS Procedural Document activities
- Actively participate in and coordinate GPS Audit & Inspection Readiness, Support & Management.
- Drive GPS Continuous Improvement (Issue Management, Process improvement, KPI development).
- Support and or manage the development and compliance monitoring of the pharmacovigilance agreements (PVAs), Safety Data Exchange Agreements (SDEAs) and other agreements as applicable with business partners
- Support, guide, and delegate GPS QM activities to other GPS QM team members as appropriate in collaboration with the Director, GPS Quality Management
- Reporting line: Director, GPS Quality Management
Join us as we transform immunology and deliver medicines that help autoimmune patients get their lives back. argenx is preparing for multi-dimensional expansion to reach more patients through a rich pipeline of differentiated assets, led by VYVGART, our first-in-class neonatal Fc receptor blocker approved for the treatment of gMG, and with the potential to treat patients across dozens of severe autoimmune diseases.
We are building a new kind of biotech company, one that maintains its roots as a science-based start-up and pushes our commitment to innovate across all corners of our business. We strive to inspire and grow our company, our partnerships, our science, and our people, because when we do, we deliver more for patients.
What you need
EDUCATION, EXPERIENCE AND QUALIFICATIONS
- At least Bachelor’s degree in pharmacy, nursing, healthcare or other life-science or technical field or country equivalent combination of education and experience
- At least 10 years of experience in the pharmaceutical/biotech industry with at least 5 years in relevant pharmacovigilance/drug safety field
- Proven track record of establishing or managing pharmacovigilance quality systems, processes and teams
- Robust experience with preparing for, hosting and responding to audits and regulatory inspections globally
- Solid working knowledge of relevant pharmacovigilance regulatory requirements and guidance documents (including Europe, US, Japan)
- Expert knowledge of GXP quality and compliance requirements, processes and measures.
Candidates must be based in Belgium, Switzerland or US (EST time zone) to be considered for this role.
Note: The recruiter will share the locally applicable annual base salary hiring range, provided in your country’s currency, during the recruitment process. This information will reflect market conditions, role scope, and internal guidelines specific to your location.
This job is eligible to participate in our short-term and long-term incentives program.
The hiring range displayed above is the range of possible base pay compensation that argenx believes in good faith it will pay for this role at the time of this posting. The hiring range is based on the job grade for this position. Individual compensation paid within this range depends on a variety of factors, including, but not limited to, internal equity, prior education and experience, job-related knowledge and demonstrated skills. argenx may pay more or less than the posted range and this range may be modified in the future.
SKILLS AND COMPETENCIES
- Excellent planning and organizational skills.
- Excellent oral and written communication skills.
- Ability to work in global environment.
- Solution oriented with ability to prioritize and work independently.
- Excellent presentation skills with the ability to communicate complex issues clearly.
- Demonstrated ability to author and contribute to procedural documents.
- Ability to motivate, influence, and collaborate with multidisciplinary teams.
- Professional level computer skills, including proficiency with tracking systems, presentation software.
- Fluency in written and spoken English.
What you'll do
GPV internal Audit program and Inspection activities
- Coordinate and manage GVP Audit & Inspection activities
- Actively engage in internal global GVP audit program and inspection readiness activities in collaboration with the argenx Quality functional area.
- Prepare GPS team members on inspection readiness activities.
- Ensure appropriate documents are readily retrievable to use during an Inspection (GPS inspection slides, CVs, JDs, PVAs are contact information is updated and readily available).
- Coordinate and prepare the GPS responses to audit and inspection findings.
Deviation & Corrective and Preventive Action (CAPA) activities
- Assess GPS issue management trends and develop / implement actions plans to mitigate systemic causes.
- Identify internal deviations and lead GPS team in determining corrective and preventive actions.
- Guide the GPS team to determine root cause of issue to avoid recurrence.
- In collaboration with the argenx Quality functional area, lead the implementation of corrective or preventive actions.
Training, Procedural Document, & Record Management activities
- Develop and implement the Pharmacovigilance training program.
- Develop, expand, and deliver the pharmacovigilance training program (procedural documents, inspection readiness, refresher training, etc).
- Work closely with key stakeholders to support and/or implement pharmacovigilance training across the organization.
- Coordinate the monitoring, maintaining, re-evaluating and updating the GPS training curricula
- Provide training to relevant argenx employees and 3rd parties (when applicable)
- Manage GPS Procedural Document activities including contributing, developing, reviewing, and continually improving GPS processes & procedures.
- Proactively engage in cross functional Procedural Document activities/forums to determine relevance to GPS and assure appropriate GPS input and review are provided.
- Support document control through use of Veeva System.
- Resolve vendor questions and escalate issues to relevant GPS staff as appropriate.
GPS Performance & Compliance activities
- Coordinate development & subsequent evaluation of Key Performance Indicators and adapt them to reflect the evolving business needs.
- Monitor compliance to 3rd party contractual obligations/PVAs and determine if there are gaps or non-conformities and report appropriately into GPS staff
- Liaise with the QA Department regarding GPS quality & compliance requirements/deliverables.
- Monitor the status of and compliance with GPS Standard Operating Procedures (SOPs) and other controlled documents.
- Coordinate the development and compliance monitoring of the pharmacovigilance agreements (PVAs), Safety Data Exchange Agreements (SDEAs) and other agreements as applicable with business partners
Other Activities
- Perform other tasks and duties as assigned by line manager or GPS Leadership
Pay and benefits
argenx didn't publish pay for this role
See what similar roles pay on Regulatory Jobs, or try the salary calculator.
Short-term and long-term incentive program
Equal opportunity, accessibility and legal noticesargenx's statements, word for word
At argenx, all applicants are welcomed in an inclusive environment. They will receive equal consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other applicable legally protected characteristics. argenx is proud to be an equal opportunity employer.
Before you submit your application, CV or any other personal details to us, please review our argenx Privacy Notice for Job Applicants to learn more about how argenx B.V. and its affiliates (“argenx”) will handle and protect your personal data. If you have any questions or you wish to exercise your privacy rights, please contact our Global Privacy Office by email at [email protected].
Job intelligence
The context around this role
Live data · November 6, 2026
Salary intelligence
How the pay compares
Director roles in the US9 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| All US (middle half) | $186,000 | $196,500 | $223,000 |
Comparisons: the base pay employers published on open Quality Systems & Document Control roles at the same level on Regulatory Jobs, November 6, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Systems & Document Control
The general path across 84 open Quality Systems & Document Control roles on Regulatory Jobs, with the titles they carry most. Not argenx's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 50 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership17
- GMP and compliance13
- Documentation and SOPs11
- Investigations and CAPA3
- Quality systems and risk3
- Data and digital systems2
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Quality Systems & Document Control work in biotechnology, led by the one this posting names, each linked to the agency or standards body that publishes it.
- EMAEU Good Pharmacovigilance Practices (GVP)(official source, opens in a new tab)EMA's modules for pharmacovigilance systems, signals and periodic reportsNamed in the posting
- FDA21 CFR Parts 210 and 211(official source, opens in a new tab)FDA current good manufacturing practice for finished pharmaceuticals
- ICHICH Q10(official source, opens in a new tab)The pharmaceutical quality system across the product lifecycle
- FDA21 CFR Part 11(official source, opens in a new tab)FDA rules for electronic records and electronic signatures
- FDAFDA data integrity guidance(official source, opens in a new tab)Data Integrity and Compliance With Drug CGMP: Questions and Answers
- ISOISO 19011(official source, opens in a new tab)Guidelines for auditing management systems
- FDAFDA Investigations Operations Manual(official source, opens in a new tab)How FDA investigators plan and conduct inspections
- PMDAJapan PMDA(official source, opens in a new tab)Japan's Pharmaceuticals and Medical Devices Agency
- ICHICH Q9(R1)(official source, opens in a new tab)Quality risk management
- EUEU GMP (EudraLex Volume 4)(official source, opens in a new tab)The EU's good manufacturing practice rules, including Annex 1 sterile and Annex 15 validation
- ISPEISPE GAMP 5(official source, opens in a new tab)A risk-based approach to compliant GxP computerized systems
- FDAFDA quality agreements guidance(official source, opens in a new tab)Contract Manufacturing Arrangements for Drugs: Quality Agreements
- FDA21 CFR 314.70(official source, opens in a new tab)Supplements and other changes to an approved application (post-approval CMC changes)
- FDA21 CFR Part 7(official source, opens in a new tab)FDA enforcement policy, including product recalls
- PIC/SPIC/S(official source, opens in a new tab)The Pharmaceutical Inspection Co-operation Scheme and its GMP guide
- ICHICH Q7(official source, opens in a new tab)Good manufacturing practice for active pharmaceutical ingredients
Company hiring pulse
argenx on Regulatory Jobs
- 10
- Open roles
- 10
- Distinct roles
- 1
- Locations
By discipline
- Regulatory5 50%
- Clinical4 40%
- Quality1 10%
By level
- Director7 70%
- Senior & Principal2 20%
- VP & Executive1 10%
More roles at argenx
- View role
Early Development Global Regulatory Lead
Remote, USDirectorBiotechnologySalary not listed
- View role
Sr. Dir. Regulatory Affairs, Head of Global Labeling and Labeling Operations
Remote, USDirectorBiotechnology$268K–$369K
- View role
Director of Medical Writing
Remote, USDirectorBiotechnology$212K–$292K
- View role
Director Regional Pharmacovigilance
Remote, USDirectorBiotechnology$192K–$264K
Similar Quality Systems & Document Control roles elsewhere
- View role
Director, Quality Systems
Wave Life Sciences USALexington, MA · HybridDirectorBiotechnology$193K
- View role
Associate Director, Quality Systems (Temporary)
Vir BiotechnologySan Francisco, CA · HybridDirectorBiotechnology$166K–$227K
- View role
Associate Director, Quality Management Systems
Dyne TherapeuticsWaltham, MADirectorBiotechnology$160K
- View role
Associate QA Systems and Process QMS Director
ExelixisAlameda, CADirectorBiotechnology$176K–$251K
Associate Director, Pharmacovigilance Quality Management, Global Patient Safety at argenx
Open until filled.