דרושים Manager Ms & ב-טבע ב-Romania, Bucharest

• 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.