Director Global Engineering - Sterile & Bio jobs at Teva in Germany, Ulm

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.

• Define OpEx capability deployment strategy in the Supply chain area (warehousing, cycle time, supply uplift, ….)
• Ensure pragmatic implementation of the program based on business priorities leveraging local OpEx team and site organization
• Play linking pin between OpEx program and supply chain, support the achievement of defined short and long term goals
• Challenge and support Supply Chain Leadership Team and Sites to leverage OpEx and progress in maturity journey
• Hands-on presence and support on site (40% travelling required)
• Ensure assessment, coaching , development of OpEx leads
• Ensure proper succession planning for OpEx site resources so that every site has always a full time OpEx lead
• Co-develop OpEx program and ensure that pilot of modules and capabilities is effective and brings desired results
• Deliver trainings and support Head of capability building
• Ensure strong connection with Strategy BPs and Supply Chain BPs
• Own maturity Journey and progression through the maturity levels
• Ensure sharing of best practices across the business
• Ensure pillar organization in place for the segment and sites
• Can own a pillar on a need basis

• Ability to connect business results and Capability building
• Track of records in delivering results through OpEx and capability building
• Relevant university degree
• Hands on experience in implementing OpEx Capability building programs
• Experience in managing and developing people
• Have performed similar role in a FMCG company is a plus
• Ability to influence laterally the organization
• Strong program management capabilities and experience in managing global programs

Global VP OpEx

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.

Position responsibilities include Quality oversight for Manufacturing, Packaging and Laboratory Operations to ensure a mature culture of quality, compliance with regulatory requirements and quality of products.

This oversight includes but is not limited to the establishment and execution of procedure; Establishment Licensing, Quality on the Floor activities including audit and release; handling of laboratory, deviation and complaint investigations; CAPA Creation and implementation; trending and metrics, compliance with validation requirements; verification that equipment, facility and utility systems are maintained in accordance with established requirements.

Lead the development, standardization, implementation, monitor effectiveness and continuous improvement of Quality Systems, global and local compliance programs, industry practices, and corporate quality initiatives. Influence quality and compliance initiatives to implement robust and proactive process improvement programs within a strong quality culture to align and demonstrate compliance to Good Manufacturing Practices

• Leads the Quality organization on site including Quality Control, Microbiology, Quality Compliance, Quality Systems and Quality Assurance Operations.
• Ensure a current Quality Management System is in place and continuously improved
• Ensure products are manufactured, released and distributed in accordance to cGMP requirements and registered specifications.
• Most senior professional and independent decision maker authority on product quality and potential market actions
• Assess and Mitigate Risks-- Identify quality risks and define proactive mitigations, to ensure the products are safe and effective before they reach the market. Work with the business to assure compliant and reliable supply
• Design and Implement the Site Quality Program—Collaborate with the Site GM and Corporate Quality to create, implement, monitor and update the site quality program.
• Manage Quality Data--Oversee the delivery of necessary data to site managers and supervisors, Corporate Quality and other internal and external stakeholders, to support the achievement of Quality objectives and ensure compliance
• Direct Quality Control-- Oversee the laboratory activity, including analytical site transfers, testing and approval or rejection of raw materials, packaging materials, in process materials and finished products for the site
• Promote a Sustainable Culture of Quality---Create, develop and maintain a culture of enhancing quality throughout the entire site operation. Create a space where people can speak openly and are encouraged to present new ideas to improve quality
• Maintain strong partnership with site leadership team
• Strategic partner in the site leadership team, with Supply Chain, Project Management, R&D, MS&T and Commercial to ensure project timelines and objectives are met
• Provide effective Quality leadership during internal, customer and Health Authority inspections
• Ensure that Quality KPIs are meeting pre-defined targets, Ensures CAPA commitments are implemented in a timely manner and its effectiveness is monitored periodically
• Plans, manages and monitors the annual Quality Operations budget and all its resources and employees. Ensure the performance and utilization of resources to provide maximum efficiency to the organization.

• Required – bachelor’s degree in chemistry, Biology, Pharmacy
• Preferred - Master or equivalent degree in Chemistry, Biology or Pharmacy

Key Requirements:

• Minimum of 10 years pharmaceutical manufacturing site quality operations and leadership experience, including:
  • Deep knowledge of cGMP requirements of local and major international authorities like EMA and US FDA for products and process,
  • High level of understanding of manufacturing, packaging, technology transfer, cGMPs, EU, ICH guidelines as well as CMC content of regulatory submissions,
  • Deep knowledge of chemical/pharmaceutical production operations/ lifecycle, production equipment/ validation and relevant technologies and product types,
  • Strong understanding and experience in Data Integrity and Compliance
  • Experience preparing and/ or leading regulatory authority GMP
  • Deep knowledge of Quality Systems
• Proven successful track record of leading organizational change to improve efficiency
• Experience leading, inspiring and coaching large teams
• Experience developing and implementing and continuously improve existing and new, efficient, and effective business processes
• Must have adequate knowledge of Quality best practices
• Must have adequate practical knowledge of pharmaceuticals manufacturing and/ or control
• Must have adequate practical knowledge of analytical techniques and microbiological principles
• Must have practical knowledge of pharmaceutical cross functional operations (e.g., Supply Chain, Engineering), product and tech transfer
• Must have practical knowledge on lean manufacturing/ lean QC and OPEX tools
• Good knowledge of environmental, health and safety requirements for laboratories and quality operations.

Position responsibilities include Quality oversight for Manufacturing, Packaging and Laboratory Operations to ensure a mature culture of quality, compliance with regulatory requirements and quality of products.

This oversight includes but is not limited to the establishment and execution of procedure; Establishment Licensing, Quality on the Floor activities including audit and release; handling of laboratory, deviation and complaint investigations; CAPA Creation and implementation; trending and metrics, compliance with validation requirements; verification that equipment, facility and utility systems are maintained in accordance with established requirements.

Lead the development, standardization, implementation, monitor effectiveness and continuous improvement of Quality Systems, global and local compliance programs, industry practices, and corporate quality initiatives. Influence quality and compliance initiatives to implement robust and proactive process improvement programs within a strong quality culture to align and demonstrate compliance to Good Manufacturing Practices

• Leads the Quality organization on site including Quality Control, Microbiology, Quality Compliance, Quality Systems and Quality Assurance Operations.
• Ensure a current Quality Management System is in place and continuously improved
• Ensure products are manufactured, released and distributed in accordance to cGMP requirements and registered specifications.
• Most senior professional and independent decision maker authority on product quality and potential market actions
• Assess and Mitigate Risks-- Identify quality risks and define proactive mitigations, to ensure the products are safe and effective before they reach the market. Work with the business to assure compliant and reliable supply
• Design and Implement the Site Quality Program—Collaborate with the Site GM and Corporate Quality to create, implement, monitor and update the site quality program.
• Manage Quality Data--Oversee the delivery of necessary data to site managers and supervisors, Corporate Quality and other internal and external stakeholders, to support the achievement of Quality objectives and ensure compliance
• Direct Quality Control-- Oversee the laboratory activity, including analytical site transfers, testing and approval or rejection of raw materials, packaging materials, in process materials and finished products for the site
• Promote a Sustainable Culture of Quality---Create, develop and maintain a culture of enhancing quality throughout the entire site operation. Create a space where people can speak openly and are encouraged to present new ideas to improve quality
• Maintain strong partnership with site leadership team
• Strategic partner in the site leadership team, with Supply Chain, Project Management, R&D, MS&T and Commercial to ensure project timelines and objectives are met
• Provide effective Quality leadership during internal, customer and Health Authority inspections
• Ensure that Quality KPIs are meeting pre-defined targets, Ensures CAPA commitments are implemented in a timely manner and its effectiveness is monitored periodically
• Plans, manages and monitors the annual Quality Operations budget and all its resources and employees. Ensure the performance and utilization of resources to provide maximum efficiency to the organization.

• Required – bachelor’s degree in chemistry, Biology, Pharmacy
• Preferred - Master or equivalent degree in Chemistry, Biology or Pharmacy

Key Requirements:

• Minimum of 10 years pharmaceutical manufacturing site quality operations and leadership experience, including:
  • Deep knowledge of cGMP requirements of local and major international authorities like EMA and US FDA for products and process,
  • High level of understanding of manufacturing, packaging, technology transfer, cGMPs, EU, ICH guidelines as well as CMC content of regulatory submissions,
  • Deep knowledge of chemical/pharmaceutical production operations/ lifecycle, production equipment/ validation and relevant technologies and product types,
  • Strong understanding and experience in Data Integrity and Compliance
  • Experience preparing and/ or leading regulatory authority GMP
  • Deep knowledge of Quality Systems
• Proven successful track record of leading organizational change to improve efficiency
• Experience leading, inspiring and coaching large teams
• Experience developing and implementing and continuously improve existing and new, efficient, and effective business processes
• Must have adequate knowledge of Quality best practices
• Must have adequate practical knowledge of pharmaceuticals manufacturing and/ or control
• Must have adequate practical knowledge of analytical techniques and microbiological principles
• Must have practical knowledge of pharmaceutical cross functional operations (e.g., Supply Chain, Engineering), product and tech transfer
• Must have practical knowledge on lean manufacturing/ lean QC and OPEX tools
• Good knowledge of environmental, health and safety requirements for laboratories and quality operations.

• Strategically plan and orchestrate the execution of the EVP, TGO daily activities.
• Defines, deploys and continuously improves an effective and efficient governance process for TGO in conjunction with transformation and lean management principles
• Provide guidance to the EVP, TGO in the management of their priorities.
• Facilitate TGO leadership team’s routines and processes including the preparation of materials for business reviews, management meetings, steering committees, strategic site visits…
• Proactively identify and seize opportunities to simplify business processes to ensure emphasis on the most value-added work.
• Foster strong relationships with the Operations Leadership Team and other key stakeholders to ensure a smooth coordination of TGO activities.
• Bridge communication and collaboration gaps between the EVP, TGO, the Executive Management Team, the Operations Leadership Team and other key leaders.
• Demonstrates and roles models the Teva leadership principles
• Review the activities of the Operations Leadership Team regularly to ensure leadership team members are aligned and focused on the right priorities.
• In partnership with TGO central functions (Transformation Office, Finance, Supply Chain, Procurement, HR, Corporate Affairs...), track TGO’s performance and progress on strategic priorities.
• Manges and prioritizes and TGO leadership external conference engagements to ensure value for Teva
• Proactively identify performance risks and secure the achievement of TGO objectives and KPIs.
• Analyze market intelligence and internal trends to advise the EVP, TGO and Operations Leadership Team and to ensure TGO remain competitive.
• Lead cross-TGO strategic projects, as needed.
• Enable a positive work environment and a high performing culture.

• Education: Bachelor’s Degree in relevant field of study required. MBA preferred.
• A minimum of 15 years of experience in disciplines requiring strong strategic planning and facilitation skills.
• Leadership experience in global pharmaceutical operations, required.
• Previous experience or training with management consulting strongly preferred
• Demonstrated ability to organize, lead and execute on a variety of assignments, managing complex projects and driving for results.
• Strong strategic agility, broad perspective, business and financial acumen.
• Sound problem-solving, effective decision making, conceptual and analytical abilities.
• Proven diplomacy and interpersonal skills including cross-functional teamwork and strong multi-cultural skills.
• Ability to craft and deliver clear and concise communication, influence audiences, and lead change management both internally and externally.

* we take care of your health (among other things through a company health management system, a company doctor, physiotherapy, sports activities and a company canteen)
* you have time for your family (through our own company kindergarten and holiday camps for school children, as well as 30 days of vacation)
* you can develop your potential to the fullest (through a comprehensive virtual training program)
* your achievements are valued accordingly (e.g. through recognition and Senior-Leaders-Programs, as well as various company events)
* we think together with you about your future (e.g. through a company pension scheme)

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.

In this position, you will be responsible for ensuring the successful execution of Teva’s Site Relationship Management strategy. Working closely with Clinical Trial Liaisons (CTLs) and key business stakeholders, you will position Teva as the Sponsor of Choice for clinical trial sites. You will lead and support the development of strategic relationships with clinical sites, Contract Research Organizations (CROs), Medical Affairs, and other internal functions to establish a best-in-class site engagement model.

• Lead training, mentoring, and oversight of Clinical Trial Liaisons (CTLs).
• Ensure the execution of strategic partnership models and frameworks to be implemented across key clinical trial sites.
• Strengthen relationships with clinical sites through collaboration with CTLs, identifying performance challenges, and optimizing site engagement to become the Sponsor of Choice.
• Work alongside Medical Science Liaisons (MSLs) and clinical/medical colleagues to support site relationships and identify new clinical sites.
• Collaborate with the CTL group and broader Global Clinical Operations (GCO) team to address study-level challenges and resolve issues in a timely manner.
• Escalate unresolved study or site issues to the manager.
• Share insights, successes, and challenges from sites with management to support process optimization, mitigation, and future planning.
• Regularly report on site performance status and track engagement and enrollment metrics.
• Identify opportunities to enhance and support site-level recruitment efforts.
• Stay informed about market activities, trends, and regulatory changes affecting clinical recruitment and improve Teva’s clinical recruitment strategy.
• Demonstrate a deep understanding of clinical sites, site networks, and the competitive clinical trial landscape.
• Assist in deploying and executing site engagement strategies, tactics, and processes.
• Coach CTLs to embody Teva’s values and serve as effective partners with clinical sites.

You are:

• A strategic thinker with a passion for clinical trial excellence and site relationship management.
• A collaborative leader, skilled at working cross-functionally with both internal teams and external stakeholders.
• Experienced in managing clinical trial sites, building relationships, and addressing challenges to improve trial performance.
• Proactive in identifying opportunities for improvement, optimizing recruitment strategies, and enhancing site engagement.
• Able to influence and collaborate across all levels of the organization, with a solid understanding of the clinical trial landscape.

You have:

• A Bachelor’s degree in a related field (Life Sciences, Clinical Trials, or a relevant discipline).
• At least 5 years of experience in the pharmaceutical or drug development industry, with a focus on clinical site management.
• Experience in people management, including coaching and mentoring teams.
• Strong knowledge of ICH-GCP guidelines, clinical trial management processes, and local regulations.
• Excellent communication skills, with the ability to build and maintain relationships at all organizational levels.
• Strong analytical and decision-making skills to address challenges and optimize site performance.
• Proficiency in English, with excellent written and verbal communication skills.

At Teva

• We take care of your health (among other things through a company health management system, a company doctor, physiotherapy, sports activities and a company canteen)
• You have time for your family (through our own company kindergarten and holiday camps for school children, as well as 30 days of vacation)
• You can develop your potential to the fullest (through a comprehensive virtual training program)
• Your achievements are valued accordingly (e.g. through recognition and Senior-Leaders-Programs, as well as various company events)
• We think together with you about your future (e.g. through a company pension scheme)

Nanci Eannucci Wene, Senior Director Site Engagement

Kacey Floyd, 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.