Associate Director Enterprise Architect Cloud jobs at Teva in Croatia, City Of Zagreb

Technology SME Leader for Sterile and Bio production

The Engineer will provide the overall subject matter expertise on Global level, on a cluster level and on a site level as needed.

Scope of Subject Matter Expert support may include – Standardization processes, Compliance GAP CAP, Reliability improvements, Machine, Facility and Process design and PS, RA processes.

This role can be based in one of our following European based sites, Croatia (Zagreb), Netherlands (Haarlem), United Kingdom (Runcorn), Romania (Bucharest), Lithuania (Vilnius) or Ulm (Germany).

BP scope through the above site processes and monitoring framework, focus but not limited to:

• CAPEX – LRP, AOP, routines, financial performance, KPIs management.
• PRODEX – Planning and management of three Eng. Related budgets – Energy, Maintenance, Consumables.
• GMI – Saving initiatives planning and projects execution.
• People – agile organization, risk management, community building.

• BS. Degree in Engineering (Mechanical/Electrical/Chemical/Industrial)
• MBA Degree - Advantage
• At least 10 years’ experience in Aseptic/Sterile technologies.
• Complex manufacturing (Respiratory, patches, etc.) - nice to have
• Experience in sterile and bio - must have
• Coordinating initiatives in a complex global environment.
• Equipment Reliability and understanding of OPEX principles.
• Excellent understanding of Aseptic/Sterile equipment industry standards and major OEM players.
• Understanding trends in equipment technology across the pharma industry.
• Large, complex, multi-level organizational interface experience.
• Global, multinational experience.

Languages:

• Fluent in English. Additional languages advantage.

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.

ESSENTIAL AREAS OF RESPONSIBILITY

The following areas of responsibility are essential to the satisfactory performance of this position by any incumbent, with reasonable accommodation if necessary. Any nonessential functions are assumed to be included in other related duties or assignments.
• Build rapport and relationships by interacting effectively with regional team members and key external contacts (ie, HCP and entire office staff) at all levels, demonstrating the awareness of their needs and responding with the appropriate action
• Provide healthcare product demonstrations, physician detailing, and in-servicing of products to current and potential customers
• Consult with physicians, nurses, and medical office staff to appropriately promote product and provide product and patient education
• Strategically manage and grow relationships with key accounts by tailoring solutions to meet their unique needs, leveraging industry insights to drive product differentiation and achieve sales targets
• Regularly review and analyze all provided sales data in order to create effective territory plans and utilize promotional budget funds
• Maintain a competitive edge by effectively addressing external market challenges while fostering a collaborative environment with internal teams to drive cohesive and successful sales strategies
• Open to working with cross-functional teams to integrate diverse expertise and insights and achieve shared objectives
• Maintain a call average as outlined in the sales plan, defined as face-to-face interactions, with healthcare providers focusing on top target customers
• Take calculated risks and apply a range of traditional and nontraditional problem-solving techniques to solve issues creatively in order to improve performance in geographical assignment
• Adhere to all Teva’s compliance policies and guidelines
• Achieve all sales performance goals, reach objectives, and complete all administrative duties for geographical assignment

Any equivalent combination of education, training, and/or experience that fulfills the requirements of the position will be considered.

• Bachelor’s degree required, preferably in related field
• At least 1 year of full-time, documented business-to-business sales experience; pharmaceutical sales experience strongly preferred

• Proven record of accomplishments in this specific market toward meeting established objectives
• Demonstrated interpersonal skills, including active listening, empathy, open communication, inclusivity, and openness to feedback
• Well-developed written and oral communication skills
• Ability to interact with HCPs in both face-to-face and virtual environments, and be proficient with technology
• Knowledge of reimbursement, managed care, or marketing preferred
• New product launch experience preferred
• Broad therapeutic area experience particularly in therapeutic area preferred
• Candidate must be able to successfully pass background, motor, and drug screening
• Valid US driver’s license and acceptable driving record required

•: Minimum 1 year
•Minimum 7 years

Regular travel, which may include air travel and weekend or overnight travel

Current territory boundaries include:

North - Scranton

South - Horsham

East - Easton

West - Reading

The annual starting salary for this position is between $88,000 - $170,000 annually. Factors which may affect starting salary within this range and level of role may include geography/market, skills, education, experience and other qualifications of the successful candidate.

We offer a competitive benefits package, including:

• Comprehensive Health Insurance: Medical, Dental, Vision, and Prescription coverage starting on the first day of employment, providing the employee enrolls.
• Retirement Savings: 401(k) with employer match, up to 6% and an annual 3.75% Defined Contribution to the 401k plan.
• Time Off: Paid Time Off including vacation, sick/safe time, caretaker time and holidays.
• Life and Disability Protection: Company paid Life and Disability insurance.
• Additional benefits include, but are not limited to, Employee Assistance Program, Employee Stock Purchase Plan, Tuition Assistance, Flexible Spending Accounts, Health Savings Account, Life Style Spending Account, Volunteer Time Off, Paid Parental Leave, if eligible , Family Building Benefits, Virtual Physical Therapy, Accident, Critical Illness and Hospital Indemnity Insurances, Identity Theft Protection, Legal Plan, Voluntary Life Insurance and Long Term Disability and more.

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.

• Design and execution of Extractable and Leachable (E&L) studies, incorporating LC/UV/MS or GC/FID/MS analytical techniques.
• Development and validation of analytical methods incorporating Mass Spectrometry detection (LC/MS or GC/MS).
• Support the characterisation of polymer materials used in medical devices and packaging, including inhalation and injectable drug products, for both small molecules and biopharmaceuticals.
• Assist in the interpretation of Mass Spectrometry (MS) data as part of compound identification studies.
• Instigate and drive scientific and technical investigations developing multidisciplinary approaches to solve wide ranging and complex problems.
• Compilation and review of detailed technical documents.
• Deliver high levels of customer service (both internal & external)

• Temporary (maternity leave cover)

• Degree, Masters or PhD qualification in Chemistry (or related discipline), with minimum 3 year’s work experience with analytical method development and validation.
• Experience in analytical method development and validation with mass spectrometry is highly desirable.
• Experience with Empower and MassHunter software is highly desirable.
• Excellent communicator (both oral and written).
• Experience of working to current Good Manufacturing Practice (GMP) or Good Laboratory Practice (GLP) and implementing policies and procedures in line with regulatory guidelines.
• Knowledge of regulatory and compliance requirements.
• Good planning and organising skills, adaptable to changing priorities.

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.

• Develop and deploy TPM methodologies, including Autonomous Maintenance and Focused Improvement
• Align TPM rollout with TLMS principles and site maturity levels
• Design and implement global reliability tools (e.g., FMEA, RCM, Root Cause Analysis)
• Lead cross-site benchmarking and best practice sharing for both technical and operational excellence solutions
• Support collaboration with Global TLMS Pillar leaders and drive proper synergies and integration with the rest of the journey
• Support cultural change and capability building in maintenance and engineering teams
• Collaborate with site teams to implement TPM pillars and measure impact on Overall Equipment Effectiveness and downtime
• Define (in coordination with global Key performance Indicators program), align and track TPM-specific Key performance indicators and improvement program/roadmaps
• Conduct reliability assessments and develop action plans to address identified gaps
• Facilitate workshops and training sessions to build TPM capabilities across sites
• Provide on the floor, hands-on support to tackle major losses for the sites. Coaching the team on how to tackle losses using the TLMS tools
• Monitor and report on the progress of TPM initiatives and their impact on operational performance
• Establish good engineering practices related to maintenance as well as building community of practices and knowledge hubs
• Co-design TPM roadmap and TPM steps evolution for advanced problem solving tools like Work point analysis, Advanced condition based analysis tools, In depth analysis on recurrent breakdown, etc.
• Support in person and remote Pillar assessment as key enable for site phase progression
• The role requires more than 30% travel time

You are

• A leader with demonstrated success in leading reliability improvement initiatives across all sites
• Someone with an analytical mindset and ability to interpret data and drive decisions
• Strong facilitator with coaching skills for cultural and behavioral change trough remote and on site support
• Experienced in conducting training sessions and workshops for engineering teams
• Fluent in English

You have

• Bachelor’s or Master’s degree in Mechanical, Electrical, Industrial Engineering, or related field
• More than 10 years of experience in maintenance, reliability, Operational excellence or continuous improvement roles in a manufacturing environment in pharma, food, or automotive industry
• Hands-on experience with Total Productive Maintenance implementation and Lean Manufacturing systems and related pillars
• Deep knowledge of maintenance strategies and reliability engineering principles
• Experience with tools such as Failure Mode and Effects Analysis, Reliability-Centered Maintenance, Root Cause Analysis, and Overall Equipment Effectiveness analysis
• Experience in implementing predictive maintenance strategies using SAP PM
• Proven track record in managing global spare parts inventory and optimization project
• Lean Manufacturing or Total Productive Maintenance certification (i.e. from Japan institute of Plant Maintenance or Black belt); Certified Maintenance & Reliability Professional (CMRP) or equivalent is preferred
• Proven experience in management of change for organizational and technical initiatives

VP, Head of Engineering Center of Excellence

Miha Pongrac
Human Resources

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.

The Netherlands, Germany, Croatia, UK/IE & Poland

• Strategic Support & Planning: Act as a strategic thought partner to the CPO and leadership team, supporting the development and execution of the global procurement functional strategy.
• Operational Excellence: Organize and drive functional performance reviews and provide insights, commitment timelines, and operational dashboards across procurement categories, regions, and key initiatives.
• Leadership Coordination: Facilitate leadership meetings, including agenda setting, meeting orchestration, and follow-up on action items to ensure accountability.
• Program Management: Lead selected high-impact, cross-functional initiatives.
• Budget Oversight: Partner with Finance to track departmental budgets, headcount planning, and resource allocations.
• Change Management: Champion change initiatives across the global procurement function and support organizational design and development.

• Extensive leadership experience in procurement, operations, consulting, or corporate strategy, with a track record of successfully guiding teams, projects, or key initiatives.
• Expertise in procurement governance, sourcing, and supplier management within global environments, with a strategic approach to driving operational excellence.
• Strong ability to navigate complex, matrixed organizations, fostering collaboration and alignment across diverse teams and stakeholders.
• Exceptional program management and executive-level communication skills, ensuring clarity, influence, and impact at all levels.
• A strategic mindset with proficiency in data analytics and procurement technologies (e.g., SAP Ariba, Coupa, Tableau), or a keen ability to leverage technology for efficiency and innovation.
• A commitment to integrity, discretion, and professionalism, serving as a trusted leader in shaping a high-performing procurement function.
• Skills:
  • Visionary strategist with a results-driven mindset, seamlessly balancing long-term planning with decisive execution.

  • Exceptional relationship-builder, fostering collaboration and trust across diverse teams and stakeholders.

  • Comfortable working in fast-paced and ambiguous environments, demonstrating agility and resilience in navigating complexity.

  • Culturally aware and globally minded, adept at working across geographies and adapting to varied business landscapes.

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.

• Prepare, publish and dispatch eCTD (CTD) lifecycle management submissions, ensuring that all final electronic deliverables meet current regulatory electronic document requirements and guidance
• Archive published dossiers and administrative data according to the internal processes
• Accurately and timely updating internal working schedules, related to assigned task
• Troubleshoot submission and document issues
• Collaborate with scientific personnel for planning, preparation, publishing and quality control checks of submissions
• Develop and maintain working knowledge of internal and external publishing standards
• Work with the Manager to ensure completion of tasks within agreed timelines
• Other assignments as required

• Master's Degree (preferred in Life Sciences or Information Technology)
• Experience in the Pharmaceutical Industry in Regulatory Operations/Regulatory Affairs is a plus
• Experience in publishing regulatory submissions and using regulatory e-submission software is a plus (Veeva)
• Basic understanding of processes and departments within a pharmaceutical company is a plus
• Good knowledge of MS Office Suite and Adobe Acrobat
• Fluent English
• Ability to multi-task, pay close attention to detail, and follow projects through to completion
• Ability to work under pressure and to tight time deadlines
• Effective time and organisation management

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.

• The ICSR Global Operations Leader is accountable for the end-to-end execution of global ICSR operational activities, including oversight and proactive management of vendor-delivered services. Reporting to the Head of Systems Data Innovation (SDI) and IL Site Lead, this role is a key member of the global SDI leadership team.
• The role leads and ensures a high-performing global team, ensuring full compliance with internal procedures and regulatory requirements while driving continuous improvement across the ICSR lifecycle - from case intake to timely, high-quality data entry and submission. It is responsible for the day-to-day execution, monitoring, and optimization of ICSR processes, with a strong focus on operational efficiency, quality, and adherence to industry standards.
• As a senior leader, the ICSR Global Operations Lead plays a pivotal role in shaping and implementing SDI strategies in close partnership with SDI leadership, cross-functional collaborators, and both internal and external stakeholders. The role provides strategic direction on operational excellence, compliance, resource planning, and global team development.
• This leader is expected to bring an adaptive, innovative mindset - serving as a change agent who empowers the team, translates strategic vision into operational reality, and champions the value of safety case management across Teva and within the broader pharmacovigilance ecosystem. With direct responsibility for both people leaders and individual contributors, the role also includes mentoring, coaching, and developing talent across regions, with a special focus on supporting the growth and engagement of the PV India team in alignment with Teva’s global PV strategy.

Croatia, Poland or Romania

1. Global ICSR Ownership & Compliance Leadership

• Serve as the Senior SME and global owner for end-to-end ICSR operations (post-marketing), accountable to meet or exceed the KPIs for ICSR quality, compliance, and operational delivery worldwide.
• Lead daily operational execution, ensuring timely case processing, proper prioritization, and resolution of workflow issues in collaboration with the relevant stakeholders.
• Contribute to the development, implementation, and maintenance of SOPs and WIs, ensuring adherence to international regulatory requirements and audit/inspection readiness.
• Oversee CAPAs, deviations, and regulatory updates for own area of responsibility, with full accountability for timely closure and continuous improvement.
• Process ICSRs in the global safety database from time to time (2-4 cases / week) - maintaining a close connection to real-time operations and reinforcing practical leadership.

2.Strategic Direction, Innovation & Process Excellence

• Define and execute the strategic roadmap for ICSR operations, aligned with Teva’s global PV vision, industry trends, and evolving regulatory expectations.
• Lead the development of robust real-time monitoring and forecasting models to support seamless execution, enhance case processing KPIs, improve operational visibility, and increase predictability and agility—shifting the organization from a reactive to a proactive, forward-looking approach.
• Champion innovation, leveraging advanced technologies such as automation, bots, and AI to drive efficiency, scalability, and simplification.
• Evaluate and enhance operating models to optimize resource use, compliance, and data quality.

3.Stakeholder Partnership & Cross-functional Engagement

• Act as the global point of contact for all stakeholder interfaces related to case intake, including Clinical Operations, Medical Affairs, and Quality.
• Establish and maintain strong, visible relationships with key partners to ensure a seamless flow of safety information and shared accountability.
• Lead and influence global working groups, forums, and cross-functional initiatives to drive alignment and best-practice adoption.
• Provide strategic insights and data to PV core leadership team to support decision-making and long-term planning.

4.Vendor & Partner Management

• Own the global vendor relationship for ICSR processing activities, including selection, performance oversight, and contractual adherence.
• Define and track vendor KPIs, conduct regular reviews, and drive accountability for quality, compliance, and operational excellence.
• Foster transparent, proactive communication with vendors and external partners to ensure aligned expectations and continuous performance improvement.

5.
Team Leadership, Development & Engagement

• Lead, mentor, and develop a high-performing global ICSR operations team with clear goals, IDPs, and accountability structures.
• Promote a culture of ownership, innovation, and continuous improvement across all team members.
• Address people-related matters proactively and partner with HR and site leadership to ensure engagement, clarity of roles, and talent growth.
• Align team capacity and structure with business needs to ensure readiness and resilience.

• Minimum Master's degree in Life Sciences or another related field.
• Minimum of 10 years of experience in pharmacovigilance with strong knowledge of ICSR lifecycle and regulatory requirements.
• Minimum of 5 years of managing global teams and complex projects.
• Experience in inspections/audits and readiness activities is a strong advantage.
• Fluent in English.