Quality Assurance (QA) Manager

Warszawa - Poland

Monthly Salary: Not Disclosed

Posted on: 4 hours ago

Vacancies: 1 Vacancy

Job Summary

As the creator and leader of the global partnership category in the pharma industry we strive to be Always Ahead and work relentlessly to bring therapy to patients in need no matter where they live.

Our values are at the core of every action we take and we are committed to going above and beyond for the benefit of the patients we serve.

We are a dynamic fast-paced company operating in over 34 countries across 5 continents. We are looking for out-of-the-box thinkers people who are passionate caring agile and adaptive to join us on our mission. If you are looking to make a difference in peoples lives we invite you to join us!

Were hiring QA Manager in Poland!

As Quality Assurance Manager youll play a pivotal role in ensuring our operations meet the highest regulatory standards and deliver exceptional quality across your this position you will lead compliance efforts drive continuous improvement and support processes that make a real impact on patients and partners.

Responsibilities:

The Quality Assurance Manager for North Cluster (Poland Lithuania Latvia Estonia Kazakhstan) will oversee quality operations to ensure compliance with regulatory standards support continuous improvement initiatives and manage QA activities while reporting directly to the Head of QA EPM actively contributing to regional and EPM-wide quality strategies.

Core Responsibilities:

Design implement maintain and continuously improve the Quality Management System (QMS) to ensure compliance with regulatory requirements.
Independently initiate review and approve SOP updates; create new SOPs and oversee periodic review of associated documentation.
Provide hands-on quality expertise to colleagues and partners to support business and compliance needs.
Participate in vendor management programs including vendor oversight QTA generation and auditing (acting as lead auditor when required) to evaluate partner/vendor QMS resources premises and equipment.
Collaborate with QA leadership to ensure compliance with the latest GMP/GDP regulations and pharmaceutical trends.
Ensure and participate in self-inspections of Medison GMP/GDP operations ensuring CAPAs are closed according to plan.
Contribute to Medison Management Reviews to assess QMS effectiveness and identify continuous improvement opportunities.
Review change control requests deviations complaints and CAPAs using risk-based principles to comply with applicable requirements.
Participate in regulatory inspections supplier audits recalls and mock recall operations.
Perform any other duties reasonably required and assigned by your manager.

City:
Bucharest

Requirements:

Required Education and Experience:

Masters or Bachelors degree in Science or equivalent
Minimum 5 years of experience in an active QA role within the healthcare or pharmaceutical sector
Strong knowledge of regulatory requirements including GDP and GMP
Proven track record in auditing and quality systems including experience as a quality auditor; experience in regulatory inspections is desirable
Ability to act as a quality function representative on various projects
Expertise in root cause analysis investigations and technical report writing
Experience in SOP creation and updates as well as other quality documentation
Excellent written and verbal communication skills; fluent English is essential
Strong critical thinking problem-solving and decision-making skills
High attention to detail and strong organizational abilities
Collaborative self-directed and able to work independently.

Required Qualifications:

Excellent interpersonal skills with the ability to build and maintain professional trusting relationships
Strong ability to work effectively in highly dynamic and changing environments; demonstrates agility and adaptability
Willingness to travel locally and internationally as needed
Flexible personality with the ability to collaborate horizontally and vertically across the organization; capable of influencing managing conflict and driving solutions
Quick learner with strong work ethic and pragmatic approach focused on results
High attention to detail and strong organizational abilities
Ability to identify and understand issues problems and opportunities while providing viable solutions
Able to work in a fast-paced dynamic environment and adjust readily to meet unexpected constraints.

Medison offers hope to patients suffering from rare and severe diseases by forming partnerships with emerging biotech companies to accelerate access to highly innovative therapies in international markets.As the creator and leader of the global partnership category in the pharma industry we strive t...