דרושים Quality Manager/ Responsible Person 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.

• 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.