Senior Specialist, Quality Assurance Auditor
hace 1 semana
**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
-
Auditor, Quality Assurance
hace 4 semanas
Tlahuac, México ICON A tiempo completo**Title: Senior Auditor (Technology & CSV)**: **At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives.** **Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as...
-
Auditor Quality Assurance
hace 2 semanas
Tlahuac, México Icon plc A tiempo completoAt ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives. Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery,...
-
Quality Specialist Senior Lead
hace 4 semanas
Tlahuac, México Boston Scientific Corporation A tiempo completo**Quality Specialist Senior Lead - CDMX**: - Remote Eligible: Hybrid- Onsite Location(s): Benito Juárez, DF, CMX, MX**Additional Locations**: N/A **Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance** At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of...
-
Quality Assurance Specialist
hace 4 semanas
Tlahuac, México DiDi Global A tiempo completoCompany Overview: DiDi Global Inc. is the world’s leading mobility technology platform. It offers a wide range of app-based services across markets including Asia-Pacific, Latin America and Africa, including ride hailing, taxi hailing, chauffeur, hitch and other forms of shared mobility as well as auto solutions, food delivery, intra-city freight, and...
-
Quality Assurance Manager, Mexico
hace 2 semanas
Tlahuac, México Gymshark A tiempo completo**OVERVIEW**: We are seeking a highly skilled and motivated Quality Assurance Manager to champion and elevate our commitment to optimal quality standards throughout our factory operations. As the QA Manager you will collaborate with regional manufacturing partners, implementing Total Quality Management (TQM) to ensure product and process quality. As the...
-
Quality Assurance Associate
hace 3 semanas
Tlahuac, México Marken A tiempo completo**Title**: Quality Assurance Associate **Job Purpose**: The Quality Assurance Associate I (QAA I) is responsible for the oversight and implementation of the Marken Quality Management System (QMS), Marken Standard Operating Procedures (SOPs), processes and policies. The QAA I also needs to ensure compliance with applicable regional and local regulations and...
-
Principal Quality Specialist
hace 1 semana
Tlahuac, México Boston Scientific Corporation A tiempo completo**Principal Quality Specialist - CDMX**: - Remote Eligible: Hybrid- Onsite Location(s): Benito Juárez, DF, CMX, MX**Additional Locations**: N/A **Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance** At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of...
-
Senior Quality Assurance Engineer
hace 5 días
Tlahuac, México Lyft A tiempo completoAt Lyft, our mission is to improve people's lives with the world's best transportation. To do this, we start with our own community by creating an open, inclusive, and diverse organization. Since 2020, Lyft Mexico has been building its team and in May 2022, we opened an office in the heart of Mexico City. We have grown to nearly 200 team members across key...
-
Customer Quality Assurance Specialist
hace 3 días
Tlahuac, México Zendesk A tiempo completoJob Description We are looking for a Quality Assurance Specialist to support our global Customer Experience (CX) teams. The QA Specialists are responsible for ensuring all established processes and procedures are being followed to support the overall customer experience. This individual must have a keen eye for detail and have the ability to provide insight...
-
Quality Assurance Analyst
hace 2 meses
Tlahuac, México Concord Servicing de Mexico A tiempo completoConcord es una empresa Americana con mas de 30 años y busca personal altamente calificado para cubrir necesidades por crecimiento. Quality Assurance Customer Service **Responsibilities**: - Maintain and develop internal support and call center quality standards; - Assess support interactions based on internal standards; - Accompany evaluations with...
-
Quality Assurance
hace 3 semanas
Tlahuac, México Marsh A tiempo completoMarsh McLennan is the world’s leading professional services firm in risk, strategy, and people through the business units: Marsh, Mercer, Guy Carpenter and Oliver Wyman. We’re creating a culture where you can bring your authentic self to work. When you join us, you bring your inclusive energy and enthusiasm to a team that values you personally and...
-
Quality Assurance
hace 3 semanas
Tlahuac, México Marsh A tiempo completoMarsh McLennan is the world’s leading professional services firm in risk, strategy, and people through the business units: Marsh, Mercer, Guy Carpenter and Oliver Wyman. We’re creating a culture where you can bring your authentic self to work. When you join us, you bring your inclusive energy and enthusiasm to a team that values you personally and...
-
Auditor Senior
hace 3 semanas
Tlahuac, México Research BSMA A tiempo completoEn búsqueda de Auditor Senior con **experiência de 6 a 8 años** en el Sector Financiero - Contable Actualmente **desempeñándose como Auditor Sr. con gente a cargo.** (Zona: Colonia del Valle) Actividades a realizar: - Identificar y **Evaluar los Riesgos** financieros, operativos y de cumplimiento asociados con la organización. - Realizar...
-
Sr Compliance Specialist I
hace 2 meses
Tlahuac, México Thermo Fisher Scientific A tiempo completoAs a Senior Compliance Specialist with responsibility for project support in the Quality Risk Management Technology Solutions team, you are responsible for coordinating set-up, maintenance and modification of the team project schedules for delivery of enhancements to the Veeva Quality Suite. The Compliance Specialist works in collaboration with Global...
-
Quality Assurance Associate Ii
hace 2 meses
Tlahuac, México Marken A tiempo completo**Title**: **Quality Assurance Associate II** **Job Purpose**: The Quality Assurance Associate II (QAA II) is responsible for the oversight and implementation of the Marken Quality Management System (QMS), Marken Standard Operating Procedures (SOPs), processes and policies required to manage and control Marken’s Storage, Distribution and Transportation,...
-
Product Engineering Specialist-senior
hace 3 semanas
Tlahuac, México Cummins Inc. A tiempo completo**PRODUCT ENGINEERING SPECIALIST-SENIOR** **Description** **IRC1046661 Product Engineering Specialist-Senior** Our culture believes in _POWERING YOUR POTENTIAL_. We provide global opportunities to develop your career, make your community a better place and work with today’s most innovative thinkers to solve the world’s toughest problems. We believe...
-
Quality Assurance
hace 2 meses
Tlahuac, México Capital Intelectual A tiempo completo**Quality Assurance** **Requisitos**: **Experiência mínima de 3 años en las áreas**:Tecnologías de la información, Sistemas, Informática, Desarrollo **Experiência mínima de 3 años en los siguientes puestos **:Testing en general, Analista de Calidad de sofware, Analista de Operaciones. **Licenciatura**:Informática, Ingeniería Sistemas,...
-
Quality Specialist Jr
hace 4 semanas
Tlahuac, México Alten México A tiempo completo**ALTEN México** is a subsidiary of ALTEN Group. ALTEN group has been a leader in engineering and information technology for more than 30 years and operates in 30 countries across Europe, North America, Asia, Africa, and the Middle East and employs more than 46,000 people, 88% of whom are engineers. The company covers the whole development cycle and offers...
-
Senior Audit Specialist
hace 2 semanas
Tlahuac, México SAP A tiempo completo**We help the world run better** **Purpose & Objective of Position** - Responsible for the delivery of moderate to high complexity audit assignments **Expectations & Tasks** - Internally recognized for Senior level knowledge of audit - Utilizes demonstrated creativity and specialist professional knowledge to deliver high quality results & solutions - Works...
-
Quality Assurance Anaylst
hace 4 semanas
Tlahuac, México AGS LLC A tiempo completo**Job Overview** The goal of the QA Analyst is to focus on the overall quality of the products before release. A skilled analyst will spend a significant amount of time on risk evaluation and requirements tracking, then use that information for preparing test plans. A minority of time will be spent on test execution. Career growth can be directed towards QA...