
Senior Specialist, Quality Assurance Auditor
2 semanas atrás
**Description of The Position**
The Senior Specialist, Quality Assurance Auditor, ensures quality and compliance with local and international regulatory requirements by conducting internal and external audits. This role provides guidance to internal stakeholders, assisting in the establishment of the company's compliance strategy and the resolution and prevention of compliance risks.
**Responsibilities**
- Evaluate Organon systems, processes, Affiliates, Vendors, Business Partners, and Investigator sites for compliance with regulatory requirements.
- Schedule and conduct GVP/GCP audits in accordance with the global audit plan ensuring compliance with local and international guidelines and regulations.
- Prepare audit reports and manage follow-up activities with limited guidance.
- Conduct meetings with Senior Management to discuss audit observations and responses.
- Supports the implementation and maintenance of the GVP/GCP risk-based strategy, including development of the annual audit plan.
- Responsible to ensure audit tracking tools are up to date.
- Participate in regulatory inspections and external audits, when required.
- Review and provide input into the quality sections of the Pharmacovigilance System Master File (PSMF).
- Maintain a high degree of knowledge of global industry expectations and GVP/GCP regulations.
- Train and mentor junior team members.
**Required Education, Experience and Skills**
- Bachelor’s degree in a relevant field (Pharmacy, Life Sciences, etc.).
- Fluency in written and spoken English, additional language skills a plus.
- Minimum of five (5) years of experience in the pharmaceutical industry.
- Minimum of one (1) years of experience in GVP/GVP auditing with EU/FDA /global regulatory requirements.
- Strong knowledge of EMA, FDA and ICH guidelines.
- Attention to detail and ability to work independently.
- Collaboration and Partnering: Demonstrates ability to work in partnership with others within the Company and external partners to accomplish quality goals; possesses advanced leadership skills.
- Communication Skills: Strong verbal skills and experienced effective writing skills.
- Project Management: Demonstrates ability to organize work efforts, prioritization of tasks and utilize appropriate resources to deliver or support work products in accordance with timelines and appropriate regulations.
- Decision Making: Demonstrates skills to utilize knowledge, networks, and data to make rapid and appropriate decisions and to determine when escalation of issues is necessary.
- Business Operations/Knowledge of Field: Demonstrates knowledge of regulations. Regulatory and business trends and applies this knowledge to optimize daily activities and ensure the functional areas within R&D are compliant with regulations and appropriate procedures.
**Secondary Job Description**
**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.
**Search Firm Representatives Please Read Carefully**
**Annualized Salary Range**
**Annualized Salary Range (Global)**
**Annualized Salary Range (Canada)**
**Please Note: Pay ranges are specific to local market and therefore vary from country to country.**
**Employee Status**:
Regular
**Relocation**:
No relocation
**VISA Sponsorship**:
No
**Travel Requirements: Organon employees must be able to satisfy all applicable travel and credentialing requirements, including associated vaccination prerequisites**
10%
**Flexible Work Arrangements**:
Remote Work
**Shift**:
1st - Day
**Valid Driving License**:
No
**Hazardous Material(s)**:
**Number of Openings**:
1
**Requisition ID**:R525813
-
QA Validation Specialist
Há 7 dias
Anapolis, Brasil Medable Tempo inteiroCompany Description Medable's mission is to get effective therapies to patients faster. We provide an end-to-end, cloud-based platform with a flexible suite of tools that allows patients, healthcare providers, clinical research organizations and pharmaceutical sponsors to work together as a team in clinical trials. Our solutions enable more efficient...
-
SEO Specialist
4 semanas atrás
Anapolis, Brasil Bionic Talent Tempo inteiro**About the Client**:Our client is a leading digital marketing agency headquartered in the USA, urgently seeking an experienced SEO Specialist to join their digital marketing team. They aim to develop tailored SEO solutions that drive organic growth and maximize online visibility for their diverse clientele. Committed to excellence, they are dedicated to...
-
Senior System Administrator
1 dia atrás
Anapolis, Brasil Luxoft Tempo inteiro**Project** Description**: US hedge fund develops and deploys systematic financial strategies across a variety of asset classes and global markets. We seek to produce high-quality predictive signals (alphas) through our proprietary research platform to employ financial strategies focused on exploiting market inefficiencies. Our teams work collaboratively to...
-
Senior System Administrator
4 semanas atrás
Anapolis, Brasil Luxoft Tempo inteiro**Project** Description**:US hedge fund develops and deploys systematic financial strategies across a variety of asset classes and global markets. We seek to produce high-quality predictive signals (alphas) through our proprietary research platform to employ financial strategies focused on exploiting market inefficiencies. Our teams work collaboratively to...
-
Senior Golang Developer
2 semanas atrás
Anapolis, Brasil Bluelight Consulting Tempo inteiroAre you an experienced software engineer with deep experience in building and shipping amazing products? Do you have high standards when it comes to code quality and user experiences? Are you the best developer on your team? Are you ready to work alongside the best engineers in the world for name-brand, industry-leading companies? **What We Are Looking...
-
Senior Java Developer
2 semanas atrás
Anapolis, Brasil Bluelight Consulting Tempo inteiroAre you an experienced software engineer with deep experience in building and shipping amazing products? Do you have high standards when it comes to code quality and user experiences? Are you the best developer on your team? Are you ready to work alongside the best engineers in the world for name-brand, industry-leading companies? **What We Are Looking...
-
Professional Services Center of Engineering
3 semanas atrás
Anapolis, Brasil VMware Tempo inteiro**Why will you enjoy this new opportunity?**Do you love solving challenging problems and delivering groundbreaking solutions? Do you like helping clients to get it right whether it means guiding design, implementation or deployment? Are you ready to grow your career by using your architecture and development expertise to bridge the gap between product and...
-
Senior Software Developer
Há 7 dias
Anapolis, Brasil AireSpring Tempo inteiroCompany Description** About AireSpring** Founded in 2001, privately held and debt-free AireSpring, is an award-winning Managed Services Provider specializing in Managed IT, Network Services, and Unified Communications, serving thousands of businesses worldwide. AireSpring provides fully managed and connected end-to-end, next-generation solutions and...
-
Division of Power, Interests and Representation:
1 semana atrás
Anapolis, Brasil United Nations Tempo inteiroResult of Service The research results will contribute to the identification of interests represented in the executive's top bureaucracy and the mechanisms by which they are introduced in this sphere and influence the government policy agenda, specifically in the justice area. With the expansion of knowledge about these processes and results, it is intended...