דרושים Ehs Lead Associate Director ב-טבע ב-Romania, Bucharest

As Lead GPV Professional, you will support Pharmacovigilance Data Quality and Case Processing Metrics, ensuring accuracy, compliance, and inspection readiness across global PV operations. Reporting to the ICSR Quality & Metrics Team Lead, you will drive oversight, analysis, and continuous improvement of ICSR processes while collaborating cross-functionally to enhance data integrity and operational excellence.

• Ensure compliance with global PV regulations and internal policies, owning key SOPs, WIs, and JAs.
• Strengthen ICSR Quality & Metrics by maintaining data integrity, inspection readiness, and seamless submissions.
• Transform data into insights by analyzing reports (e.g., QlikSense, V-Safe) and driving meaningful improvements.
• Collaborate with cross-functional teams to enhance compliance reporting and streamline processes.
• Lead projects that improve case quality, compliance, and performance.
• Act as a business owner for selected GPV tools, shaping the SDI strategy.
• Promote continuous improvement through root-cause analysis and innovative solutions.
• Share knowledge, mentor others, and help the team reach its annual goals and KPIs.

• Minimum Master's degree in Life Sciences or another related field.
• Minimum of 3 years of Biopharmaceutical/CRO industry experience, including a large international organization.
• At least 1 year of direct people/project leadership experience.
• Experience in handling Health Authority Inspections.
• Project Management experience is an advantage.
• Fluent in English.

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.

We are seeking an experienced and strategic EHS Lead (Associate Director) to oversee and continuously improve our Environment, Health, and Safety programs at the factory level. This is a key leadership role responsible for ensuring compliance with Romanian legislation and corporate policies, while fostering a culture of safety, sustainability, and operational excellence. You will also coordinate Business Continuity Management (BCM) and administrative functions, playing a vital role in protecting our people, assets, and the environment.

You bring over 5 years of hands-on experience in EHS, with at least 3 years in a leadership role.
You’ve successfully managed complex safety systems in a regulated environment and have a strong track record in implementing ISO standards, managing audits, and leading cross-functional teams.
Your ability to balance strategic oversight with operational execution makes you a trusted advisor and effective leader.

- University degree in a relevant field.
- Specialized certifications in occupational safety and environmental protection.
- In-depth knowledge of Romanian OHS and environmental legislation.
- Proven experience with ISO 14001 implementation and EHS audits.
- Strong leadership, communication, and team coordination skills.
- Experience managing budgets, KPIs, and performance metrics.
- Fluent in Romanian and English (written and spoken).
- Familiarity with GMP compliance and manufacturing best practices is a plus

Curs în domeniul securității și sănătății în muncă
Curs evaluator de risc SSM
Curs Cadru Tehnic PSI
Curs Inspector de mediu si Responsabil Gestionare deseuri

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.

As anyou will conduct activities necessary for the determination of the safety profile and the characterization, monitoring, and mitigation of risk for the assigned products throughout the product lifecycle and provide comprehensive safety information to patients, prescribers, and regulators.

• Be accountable for medical evaluation/interpretation of aggregate safety data of assigned products and non-assigned products, as required, including, but not limited to, signal detection and evaluation, dose escalation evaluations, regulatory safety reports (PSUR, PADER, DSUR), and ad-hoc safety review/assessments (such as Health Hazard Assessments, abbreviated safety evaluations, and Health Authority requests).
• Review complex Health Hazard Assessments and Health Authority requests.
• Perform signal management activities such as signal validation QC, authoring of complex signal evaluations, and signal evaluation review. Act as medical reviewer to assess causality, consolidate safety information from different sources to determine whether a signal qualifies as a risk.
• Support risk management activities for assigned products globally and contribute to the preparation of Risk Management Plans (RMPs), REMS, design of additional risk minimization measures as well as management of these plans throughout the product’s lifecycle. The Safety Physician is responsible to define the important identified risks, important potential risks, and the missing information.
• Represent PV in cross-functional Product Label Working Group. Conduct evaluation and determination of safety related sections of the product label, both initial and throughout the product lifecycle; key member for safety related label negotiations with regulatory agencies as well as in the development and maintenance of CCSI.
• Provide PV support and safety contributions to Health Authority submissions and responses. Represent safety during due diligence of products.
• Collaborate with different functional internal (Medical Affairs, Clinical Development, Quality, etc.) and external stakeholers (KOLs, CROs, etc.) effectively representing PV position on any safety concerns as well as the overall safety profile of assigned products. Collaborate with other cross-functional teams to ensure execution of the safety strategy.

•
• Clinical practice experience and/or epidemiological degree/training
• Experience working in pharmacovigilance and drug safety, as a safety physician –
• Proven ability to handle safety surveillance tasks and chair safety committee meetings
• Ability to serve as a subject matter expert
• Outstanding communication skills with an ability to collaborate with different departments and partner with and influence others without direct authority
• Ability to work cross-functionally within a matrix / international team across multiple time-zones
• Oral and written
fluency in English

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.

• Oversee end-to-end production operations, including manufacturing, planning, and storage, in compliance with GMP and internal quality systems.
• Approve and implement production plans and ensure execution meets targets for quality, timelines, and efficiency.
• Champion compliance by ensuring procedures, production orders, and documentation align with quality and regulatory standards.
• Lead investigations into deviations and non-conformities, identifying root causes and implementing corrective actions.
• Optimize manufacturing processes and technology, continuously seeking improvements in cost, quality, and throughput.
• Manage production budgets and monitor key economic and technical indicators to ensure performance within targets.
• Direct and develop a skilled production team, fostering a culture of safety, accountability, and operational excellence.
• Collaborate cross-functionally with QA, R&D, Validation, IT, and Supply Chain to ensure seamless flow of operations.

• University degree in Pharmacy, Chemical Engineering, Industrial Engineering, or a related scientific field.
• Minimum 5 years of experience in pharmaceutical or GMP-regulated production environments, including 3+ years in a leadership role.
• Proven operational excellence, expertise in GMP compliance, quality systems, and manufacturing best practices.
• Strong understanding of production planning, documentation standards, change control, and technical process optimization.
• Experience managing budgets, KPIs, and performance metrics in a regulated setting.
• Exceptional leadership and communication skills with a demonstrated ability to lead cross-functional teams.
• Comfortable working in a fast-paced, matrixed organization, balancing strategic thinking with hands-on execution.
• Fluent in English (written and spoken); Romanian language fluent.

• Competitive compensation package aligned with experience and a company car.
• Benefits package: meal vouchers, healthcare subscription to a private clinic.
• Highly professional team and organizational culture with strong values.
• Professional development within the company.
  

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.

Sindan is looking for the futureUtilities Maintenance Leadwho will have the following main responsibilities:

Responsible for plant's utility assets, equipment and systems (such as high voltage electricity infrastructure, cooling&heating systems, gas systems, HVAC, Steam (black&clean), water, communication, in aspects of reliability, availability and value preservation in order to accomplish the goals of production.
Responsible for execution of CAPEX projects: Implementation of system and equipment in accordance with regulatory requirements, engineering standards (budget, time, scope) and Good Manufacturing Practice (cGMP).

Site Utility management and optimization: Manages the business of the utility maintenance having end-to-end responsibility for achieving the facility equipment and system's reliability, availability and value preservation.
EHS&S and cGMP compliance: Ensures the implementation of Standard Operating Procedures relating to utility assets, equipment and system maintenance, and compliance with local/global requirements of Quality, EHS&S and Good Manufacturing Practice (cGMP).
Budget management: Plans and monitors utility operational budget of maintenance and staffing.
People Management: Manages a team of utility maintenance employees, ensuring their proper level of competencies and supporting their development.
Supplier/Contractor Management: Responsible for communication and relationship with equipment suppliers and maintenance services as well as internal stakeholders such as Procurement.

Manages the business of the Utility Management organizational unit:
Responsible for supervision, maintenance and support of the plant's utility assets, equipment and systems, to support the business goals.
Establishes process standardization to ensure managing and maintaining equipment and systems in compliance with good engineering practice, EHS&S and cGMP standards.
Manages, plans and monitors the utility operational budget. Identifies and maintains required spares to ensure proper functioning.
Exercises management authority; including recruitment, discipline, termination, sets employee performance objectives, conducts performance reviews and recommends pay actions. Ensures employees' proper level of competencies and support their development.
Responsible for equipment and maintenance supplier relationship. Ensures legal compliance with authorities' requirements, permits etc
Strives to continuously improve the business, ensures functional requirements are met, and support new implementation of facility equipment and systems when needed.

Technical experience in project management in the Pharma/medical equivalent industry
industry
A minimum of 6 years in the pharmaceutical industry
Minimum of 3 years of managing maintenance departments

Well familiar with pharmaceutical industry regulations and requirements, including quality and EHS&S in the scope of engineering.
An academic BSc engineering degree from a well-known academic institution in mechanical, chemical, or another relevant field. (electronic, industrial, etc.).

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.

Sindan is looking for the futureEquipment Maintenance Leadwho will have the following main responsibilities:

Responsible for manufacturing assets and equipment, in aspects of reliability, availability and value preservation in order to accomplish the goal of production.
Responsible for execution of CAPEX projects: Implementation of system and equipment in accordance with regulatory requirements, engineering standards (budget, time, scope) and Good Manufacturing Practice (cGMP).

Site production equipment management and optimization: -
Ensures that assets, equipment and systems in the plant are available, qualified, and functioning to meet site KPIs.
Maintenance and supervision of equipment operation and processes, as well as infrastructure elements within the area of activity of maintenance of equipment and systems.
EHS&S and cGMP compliance: Ensures the implementation of Standard Operating Procedures relating to equipment and system maintenance, and compliance with requirements of Quality, EHS&S and Good Manufacturing Practice (cGMP).
Budget management: Plans and monitors equipment operational budget of maintenance and staffing.
People Management: Manages a team of equipment/maintenance employees, ensuring their proper level of competencies and supporting their development.
Supplier/Contractor Management: Responsible for communication and relationship with equipment suppliers, maintenance services and OEMs, as well as internal stakeholders such as Procurement. Ensures legal compliance with authorities requirements, permits etc

Manages and develops the business of the Production Equipment Maintenance organizational unit:
Responsible for supervision, maintenance and support of the plant's production equipment, to support the business goals.
Accountable for ensuring the equipment reliability and availability, and plays a critical role in safeguarding the assets of the organization and ensuring the uninterrupted operations of the business.
Establishes process standardization to ensure managing and maintaining equipment and systems in compliance with good engineering practice, EHS&S and cGMP standards.
Manages, plans and monitors the equipment operational budget. Identifies and maintains required spares to ensure proper functioning.
Exercises management authority; including recruitment, discipline, termination, sets employee performance objectives, conducts performance reviews and recommends pay actions. Ensures employees' proper level of competencies and supports their development.
Responsible for equipment and maintenance supplier as well as OEM relationship. Ensures legal compliance with authorities' requirements, permits etc
Strives to continuously improve the business, verifies preventive maintenance, ensures functional requirements are met, and supports new implementation of equipment to support the business needs.

Technical experience in project management in the Pharma/medical equivalent industry

A minimum of 6 years in the pharmaceutical industry
Minimum of 3 years of managing maintenance departments

Well familiar with pharmaceutical industry regulations and requirements regarding quality and EHS&S in the scope of engineering.

An academic BSc engineering degree from a well-known academic institution in mechanical, chemical, or another relevant field. (electronic, industrial, etc.).

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.