Informacje o stanowisku

Opis stanowiska pracy

Quality Assurance Team Manager
Warszawa
NR REF.: 1192899

One of our clients from the pharmaceutical industry is building a new hub in Warsaw and is looking for talented professionals, that would contribute to its success by joining the new team.We are looking for Quality Assurance Team Managers who would play a crucial role in ensuring the quality of the company’s products, maintaining compliance with regulatory standards. The Team Manager will have close collaboration with the Team Managers in Poland and Denmark and report to the department manager of the Life Cycle Management (LCM) & Release department. 

Main objectives are to:

• Ensure that company’s products are released correct, unanimously and in compliance with EU GMP, GDP and Orifarm Quality Management System
• Ensure Life-cycle-management activities for company’s products where Generics A/S is Marketing Authorisation Holder or distributer is performed in compliance with EU GMP, GDP and Orifarm Quality Management System.
• Ensure daily operation 

Office location: WarsawHybrid model: 3 days office-based, 2 days home-office

Main responsibilities:Department Leadership and Development:

• Daily manage the LCM&Release team and foster a collaborative and supportive work environment.
• Provide mentorship and development opportunities to team members, enhancing their skills and career progression.
• Conduct regular performance evaluations and foster a culture of constructive feedback

Stakeholder Communication:

• Close collaboration with TMs in LCM&Release department
• Sparring, coordination and knowledge exchange with other managers in Corporate Compliance and main stakeholders in Product Supply and Supply Chain organization.
• Communicate quality escalations and risk assessments to internal stakeholders according to described escalation route. 

Process Management and Continuous Improvement 

• Process owner responsible for (PQRs, EI/Nitro, Complaint management, Stability, external deviations, OOS management) 
• Identify continuous improvement to optimize LCM processes and improve team performance.
• Ensure team is being trained and developed to stay abreast of industry trends and advancements.

Operational Excellence 

• Manage daily operation and ensure LCM and release activities are performed efficient and in compliance to described procedures.
• Monitor and evaluate key performance indicators (KPIs) to ensure operational goals are met.

Compliance and Regulatory Affairs:

• Ensure compliance with global QMS, guidelines, EU GMP and GDP legislation and industrial best practices.
• Issue escalation and notification and define corrective and preventive actions to specific quality issues identified. 

Ad Hoc

• Take over additional tasks that may be required in accordance with the overall goals of the company.
• Participate in assigned projects and working groups 

Requirements:

• Academic educational background: Master of pharmaceutical science, master of medicinal chemistry, master of science in chemistry, chemical engineer, master in biochemistry, Master of manufacturing engineering. 
• Experience: Minimum of 3 years of experience in Quality Assurance or Quality Control, with at least 1 year in a management or leadership role. Background in pharmaceuticals, food, medical devices, wind power or other highly regulated industries. Background in operations or quality areas preferable from manufacturing sites or headquarter. 
• Leadership Skills: Demonstrated ability to lead, mentor, and develop high-performing teams. Strong interpersonal skills and empathy to understand and support team members. Proven change management skills.
• Communication: Excellent verbal and written English communication skills. Ability to effectively communicate complex quality related information to internal and external stakeholders. Experience from communication in international companies is preferred.
• Problem-Solving: Strong analytical and problem-solving skills. Ability to make informed decisions and manage risks.
• Project Management: Proven experience in project management, including planning, execution, and monitoring of project activities.
• Regulatory Understanding: Knowledge of global regulatory requirements and guidelines related to quality incl. EU GMP and EU GDP.
• LEAN Skills: Proven experience with LEAN methodology, tools and operational management. 

What you39ll get in return

• Career in an organization with Scandinavian culture and values: Experience a work environment that emphasizes equality, work-life balance, and sustainability.
• Work in a hybrid model (3 days in the office per week)
• Potential for a permanent contract after an initial 3-month period.
• Comprehensive medical coverage through Medicover.
• Sports Card: Access to various sports facilities and activities.
• Life insurance coverage for added security.
• Opportunity to be involved in the transition of processes.
• Attractive and competitive salary.

Hays Poland sp. z o.o. is an employment agency registered in a registry kept by Marshal of the Mazowieckie Voivodeship under the number 361.

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