Quality Manager/ Responsible Person jobs at Teva in 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.

• Overall responsibilities for activities of engineering.
• Monitoring / review of procedures, cGMP records in engineering store and to ensure compliance.
• Prepare / review of Engineering store SOP’s in Glorya Electronic Data Management System.
• To ensure readiness of the department for regulatory inspections and ensure their compliance.
• Up keeping of engineering store compliance.
• Initiation / execution of Change Controls, Deviations, Investigations, CAPA’s in Trackwise System for engineering store and its timely closure.
• Follow up for any deficiency and corrective actions.
• Physical stock verification and it’s reconciliation to confirm the availability of stock for effective procurement of material in co-ordination with cross functional departments and share the list of materials availability monthly once to immediate supervisors.
• Upgradation / maintenance / alteration / renovation of engineering store facility in coordination with engineering department.
• Monitoring of receipt / issuance of miscellaneous, UD clearance of materials/miscellaneous, consumables and ancillary materials and its documentation.
• Ensure verification of physical inventory count as per inventory count cycle.
• To motivate the team member for reporting of near miss events and non-safety incidents.
• Monitoring of disposal of scrap from scrap yard area and up keeping of scrap yard.
• Monitoring of disposal of miscellaneous/chemical process as per standard procedure in engineering store with its documentation and controls.
• Printing/pasting of quarantine labels on ancillary materials.
• Ensure compliance of material handling in engineering store as per SOX.
• Ensure compliance to the requirement of policy and procedure on data integrity.
• Handling of SAP R/3 System (engineering store related transactions), Trackwise System and Glorya Electronic Data Management System (as applicable).
• Ensure all assigned training requirements are completed in learning platform (Studium).
• Co-ordination with cross-functional departments for smooth functioning of department activities.
• Ensure departmental safety by giving the awareness training for handling of miscellaneous, consumables and ancillary materials to the engineering store persons and implementation of good safety practices in engineering store.
• To follow the normal safety precautions in working area and ensure departmental safety at all times.
• Responsible for maintaining disciplined work culture in working area.
• Ensure compliance to the requirement of policy and procedure on data integrity.
• Any other responsibilities assigned by the reporting authority.

• Education /Qualification: Diploma / Degree in Engineering
• Experience: 7- 9 years of relevant experience

• Acting as the Responsible Person (RP), ensuring full compliance with GDP, national and EU pharmaceutical regulations, and narcotic distribution laws.
• Independently overseeing market release, recalls, and complaints related to medicinal products.
• Leading quality management processes, including audits, SOPs, CAPAs, change control, and documentation systems.
• Communicating directly with national health authorities and hosting inspections with full readiness at all times.
• Maintaining licenses and authorizations related to medicinal and narcotic products, including reporting to authorities.
• Providing strategic quality guidance and partnering closely with the General Manager and cross-functional commercial teams.
• Leading and executing risk management activities across the distribution chain.
• Participating in European-level quality councils and ensuring implementation of regional initiatives locally.
• Ensuring continuous GDP training, quality awareness, and inspection readiness.
• Being the key local quality contact for both internal stakeholders and external regulatory bodies.

• Master’s Degree in Pharmacy, Medicine, or Biology (Pharmacist license mandatory); advanced degrees are a plus.
• Minimum 3 years of experience in a RP, QP, or QA Manager role in a pharmaceutical company, ideally in a large international organization.
• Proven ability to work independently, with full ownership of RP and QA responsibilities.
• Strong understanding of GDP, GMP, and Romanian/EU legislation including those related to narcotic substances.
• Experience managing health authority inspections, quality systems, and regulatory submissions.
• Excellent communication skills and ability to influence at all levels of the organization.
• Track record of implementing quality systems, continuous improvement, and issue escalation.
• Fluent in English; Romanian language proficiency is essential for regulatory communications.
• Strong problem-solving, decision-making, and risk assessment capabilities.

• Competitive compensation package aligned with experience.
• 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.

This role sits at the intersection of science and operations, playing a crucial part in supporting technology transfers, process optimization, and GMP compliance in a highly regulated environment.

You’ll lead a small, dedicated team while collaborating with cross-functional departments to ensure seamless production and adherence to the highest industry standards.

• Coordinate and execute validation and qualification activities (process, cleaning, equipment, utilities, and computerized systems).
• Draft, review, and approve validation protocols and reports, interpreting results and ensuring GMP compliance.
• Supervise the development and execution of the General Validation and Calibration Plans for the site.
• Lead cleaning validation processes in collaboration with QC and Production teams.
• Oversee media fill activities and validation of aseptic processes for injectables.
• Support tech transfers and process improvements with a strong technical and operational excellence mindset.
• Manage and train a team of 3–5 validation specialists, ensuring technical expertise and performance.
• Ensure timely and accurate completion of all validation-related documentation and deviation handling.
• Collaborate with cross-functional teams (Production, QA, QC, Engineering) to enhance operational and compliance standards.
  

• Academic background in Pharmacy, Chemistry, Engineering, or related scientific discipline.
• 5+ years of experience in the pharmaceutical industry, with a focus on validation, cleaning validation, and injectables.
• Solid understanding of media fill processes, GMP, and aseptic manufacturing.
• Hands-on experience in technical validation processes, including equipment qualification and computerized systems validation.
• Strong understanding of manufacturing processes and how various production areas interconnect.
• Proven ability to analyze data, create clear documentation, and lead investigations and improvements.
• Experience managing or mentoring small technical teams (3–5 direct reports).
• OPEX mindset and readiness to drive continuous improvement initiatives.
• Strong communication skills and ability to work cross-functionally in a matrix environment.
• Fluent in English (written and spoken); Romanian language fluent.

• Competitive compensation package aligned with experience.
• 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.