דרושים R&d Sourcing Manager - Tapi ב-טבע ב-Hungary, Debrecen

TAPI is the leading international supplier of active pharmaceutical ingredients (APIs). With
the industry's broadest portfolio including over 350 API products, TAPI is the go-to global

We are looking for a Sr Manager, Microbiology-Quality Compliance Expert - TAPI.
The main purpose of your job will be to ensure that the Microbiology laboratories, systems , procedures related to Quality Compliance System at TAPI sites is in place, securing compliance of activities, OOS investigations, Micro CCS, quality risk management, escalation of risks, and continuous improvement. Your role will include providing governance through strong collaboration with manufacturing site operations to foster excellence in inspection management and inspection readiness at TAPI sites. You will support manufacturing site remediation activities directly.This role will ensure that each site receives the right level of support to sustain and continuously improve GMP compliance related to Microbiology and other quality compliance support, to strategize the development and overall implementation of remedial plans, to solve quality-related compliance issues, to identify areas of improvement for quality operational performance in line with business needs and in accordance with TAPI standards. Moreover, you will foster and develop onsite Quality culture across all sites.

• Support the Implementation of the Site Inspection Readiness Program focusing on Microbiology labs and related areas
• Input, Review and Approval of Complex Investigations ( OOS, Deviations, Incidents, etc.)
• End to End Support for Health Authority Inspections focused on Microbiological aspects
• Support the Implementation of Quality Risk Management
• Review and Monitor Quality Improvement Plans
• Train Site Colleagues on the Microbiology fundamentals, investigations, and Corporate Standard System
• Support Global Quality Compliance Initiatives eg; Cross contamination strategies
• Data Reliability assessments, gap evaluations, GxP data mapping in the micro labs
• Review global TAPI policies and standards and provide inputs
• Expected to spend reviewing QMS areas outside microbiology subject that related to QIPs, Data trending, signal detection, managing quality forums, leading CoPs related to Microbiology and relevant Quality management systems ( CAPA, Investigations, QRM etc)

• Establish and monitor governance on data integrity requirements.
• Cooperate with other functions on Quality projects and their role out.
• Act as a quality SME and support global compliance initiatives upon request
• Participate in audits upon request.
• Fosters knowledge sharing among sites within the TAPI

• Degree in Industrial Microbiology and demonstrated knowledge in cGXP regulations.
• 10+ years' experience in GMP environment, continuous professional development 5+ years' experience in Microbiology laboratory, managerial tasks, organization Exposure to International working environment
• Mix of experience in Micro, Quality systems would be preferred.
• Very good understanding and insight into the different aspects of quality functions like QC, QA, Quality Systems, Compliance, etc.
• Sound knowledge of regulatory standards and guidance in Pharmaceutical Industry and expectation of global regulatory bodies, including US FDA, PMDA and ANVISA requirements
• Performance management and reporting
• Project management, monitoring, execution and reporting
• Problem solving and good team work skills
• Proactive orientation, communication skills
• Proven influencing capabilities
• Fluent in English

TAPI will carry out appropriate verification and legally permitted vetting prior to the confirmation of any offer of employment. More information on this verification and vetting will be provided if you reach this stage of the application process.

If you are a current TAPI employee, please apply using the internal career site available on "Employee Central". By doing so, your application will be treated with priority. You will also be able to see opportunities that are open exclusively to TAPI employees. Use the following link to search and apply:

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-depth understanding of the TAPI R&D needs, IP status, product's strategy, regulatory requirements and timelines.
• Manage the sourcing activities for intermediates required for TAPI R&D development
• Source for suitable intermediates by mapping and evaluating the available options in the market (active and silent search)
• Identify potential suppliers and conduct RFPs, analysis, cost modeling and risk management.
• Provide professional and expert-level knowledge of the key raw materials supply base and global intermediates market (suppliers, prices, technology etc')
• Negotiate intermediates pricing with suppliers and contact developers to achieve aggressive savings targets - To be aligned with the current and future cost of the product (in R&D and commercially)
• Negotiate and set development and supply agreements with contract manufacturers for TAPI Key raw materials and follow up until fully signed.
• Set and support product strategy and risk mitigation plan to be aligned with global procurement and business needs which will be reviewed and adjusted periodically.
• Ensure continuous evaluation and global high-risk execution mitigation plan for securing key raw materials and starting materials supply base for TAPI R&D products.
• Initiate and ensure commercial and QA audit prior to submission.
• Manage supplier relationship within category (SRM Initiative), undertaking strategic supplier performance improvement actions as required
• Ensure sourcing/approval of commercially viable, high compliance and cost competitive sources for all Key Raw materials / starting materials to support successful launches.

Must excel in problem-solving and thrive in a fast-paced, dynamic environment, adapting quickly to changing market conditions and organizational needs.

• At least 5-10 years of experience in Direct procurement (Pharma industry experience preferred)
• Master's degree in natural sciences, pharmaceutical sciences, biotechnology or equivalent
• Experience in API/Intermediates Manufacturing and/or API/ Intermediates Development is preferred
• MS office skilled
• Strong interpersonal skills including cross-functional teamwork,
• A proactive and positive approach to challenges, demonstrating a willingness to take on new tasks and find solutions
• Ability to work autonomously, make decisions and resolve/follow up issues quickly
• Flexibility to thrive in a fast-paced, dynamic environment and adapt to changing conditions.
• Ability to draw strategic insights from analysis and effectively summarize and present insights
• Sensitivity and awareness of cultural differences to effectively collaborate with global teams and stakeholders.
• Fluent English (both written and verbally)

• Job contract with competitive salary and flexible working hours
• Hybrid work model
• Annual bonus and annual salary increase
• Flexible working hours
• 5 Weeks of annual leave, 3-5 sick days, and additional leave beyond the labor code
• Meal allowance of 82 CZK per day
• Cafeteria contribution of 17,000 CZK / year, option for MultiSport Card, and contributions to pension and life Insurance
• Laptop, phone nad mobile plan for the entire family
• Additional financial rewards for proactive approach
• Recreational facility in Karlov pod Pradědem
• Rewards for work and life anniversaries
• Premium medical care and covered vaccinations
• Assistance program – free psychological, financial, and legal counseling
• 1 day of leave for volunteering activities
  

Assoc Director, Global R&D Sourcing Lead TAPI

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.