Sr. Specialist, RA/PV Quality Business Partner
The Sr. Specialist, RA/PV Quality Business Partner (QBP), performs tasks that help improve and sustain global and local quality and compliance of regulatory affairs and pharmacovigilance activities for all products within the Organon portfolio of drugs, medical devices, and combination products that are commercialized or in development globally. These roles will often work in collaboration with colleagues in the ORD Regulatory Affairs & Affiliate Pharmacovigilance (RAaPV) and/or Global Pharmacovigilance and Safety Science (GPSS) teams. These roles report directly to the Executive Director, Quality Business Partner for Regulatory Affairs and Pharmacovigilance.
- Simplify processes and systems, in collaboration with functional colleagues, to ensure the procedural frameworks governing RAaPV and GPSS activities are compliant and fit for purpose at Organon.
- Ensure change control for all PV procedural documents, including robust impact analyses and training programs prior to implementation.
- Support audit and inspection readiness of the RAaPV and GPSS organizations.
- Perform tasks related to due diligence and integration of new (potential) portfolio assets, as assigned.
- Perform root cause analysis and write CAPA plans associated with quality issues and audit/inspection findings, in collaboration with RAaPV and GPSS colleagues.
- Foster a culture within ORD that prioritizes quality and compliance in consideration of everything we do.
- Review and approve procedural documents and associated training plans, ensuring proper change control.
- Work directly with RAaPV and/or GPSS and other stakeholders to facilitate timely and proper execution of investigations of quality issues, including impact analysis and root cause analysis. Shape the content of CAPA plans that will maintain the integrity of the procedural framework and promote inspection readiness. Execute effectiveness checks against completed CAPAs, as applicable, and write reports that provide determinations of effectiveness with rationale. File all documentation in appropriate repositories.
- Develop data-driven reports of RAaPV and/or GPSS performance against a pre-defined set of quality- or compliance-indicating metrics. Analyze reports for trends and recommend actions to minimize risks identified in the report.
- Participate in PV-related inspections of Organon to ensure clear and concise information about the PV system is provided to inspectors. Inspection tasks may include working with RAaPV and/or GPSS to develop or QC inspection responses and storyboards, track inspection responses against pre-defined timelines, and/or ensure appropriate CAPA commitments are developed in response to findings.
- Perform research in support of due diligence and integration activities, as assigned.
- Participate in regulatory intelligence and surveillance activities for emerging regulations in any geography that may impact the Organon PV system.
- Generate various documents (such as reports, presentations, or quality agreements) to support key quality management system activities.
General Microsoft applications
Workflow-based IT system applications
Dynamic data-based dashboard applications
(professional and/or technical)
Advanced - communication (verbal and written)
Moderate – leadership, self-awareness, interpersonal
Moderate – strategic (big picture oriented) with attention to detail
Moderate – knowledge of international laws and regulations governing the research and development, and safety surveillance, or drugs and medical devices
Moderate – understanding/experience with end-to-end drug and/or medical device R&D and submission processes and systems
Moderate – writing simple and effective procedural documents
Novice – knowledge and experience with quality management systems, change control, root cause analysis, and CAPA
Novice – understanding/experience with audits and health authority inspections
Novice – ability to analyze data to create and present visualizations of organizational performance and identify trends based on these metrics
5+ years of experience in medical device and/or pharmaceutical industry
2+ years in jobs related to regulatory affairs or pharmacovigilance/safety surveillance.
Advanced English Skills 90+
Education / Certificates
Bachelors Degree or equivalent in a scientific or technical field related to the healthcare/pharmaceutical industry, or licensed Healthcare Professional degree (such as R.N., R.Ph., P.A.)
Who We Are:
Organon delivers ingenious health solutions that enable people to live their best lives. We are a $6.5 billion global healthcare company focused on making a world of difference for women, their families and the communities they care for. We have an important portfolio and are growing it by investing in the unmet needs of Women’s Health, expanding access to leading biosimilars and touching lives with a diverse and trusted portfolio of health solutions. Our Vision is clear: A better and healthier every day for every woman.
As an equal opportunity employer, we welcome applications from candidates with a diverse background. We are committed to creating an inclusive environment for all our applicants.
If you require reasonable accommodation(s) in completing an application, interviewing, or otherwise participating in the employee selection process, please email us at email@example.com.
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Annualized Salary Range
Travel Requirements: Organon employees must be able to satisfy all applicable travel and credentialing requirements, including associated vaccination prerequisites
Flexible Work Arrangements:
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Number of Openings:1