RA/PV Quality Business Partner (Senior Specialist)

Job Description

Overview

Job Title

Senior Specialist, RA/PV Quality Business Partner

Organization / Division / Department

ORD/QSS/Quality & Compliance

Location / Site

Multiple Countries/Locations

Business Address (do not use home address)

Relevant to Organon affiliate office locations in Portugal, United Kingdom, China, Columbia

Position Description

Position Overview

The Senior 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.

Responsibilities:

• 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 root cause analysis and write CAPA plans associated with quality issues and audit/inspection findings, in collaboration with RAaPV and GPSS colleagues.
• 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.
• Develop data-driven reports of RAaPV and/or GPSS performance against a pre-defined set of quality- or compliance-indicating metrics.
• Participate in PV-related inspections of Organon to ensure clear and concise information about the PV system is provided to inspectors.
• 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.

Requirements:

• Bachelor's 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.).
• Knowledge of international laws and regulations governing the research and development, and safety surveillance, or drugs and medical devices.
• Experience in medical device and/or pharmaceutical industry.
• Knowledge and experience with quality management systems, change control, root cause analysis, and CAPA.
• Understanding/experience with end-to-end drug and/or medical device R&D and submission processes and systems.
• 2+ years in jobs related to regulatory affairs or pharmacovigilance/safety.
• Understanding/experience with audits and health authority inspections.

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 staffingaadar@organon.com.

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Annualized Salary Range

Employee Status:

Relocation:

VISA Sponsorship:

Travel Requirements: Organon employees must be able to satisfy all applicable travel and credentialing requirements, including associated vaccination prerequisites

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

Requisition ID:R519028