Quality Compliance & Systems Operational Specialist

ICON Strategic Solutions; Polska; On-site; PLN 180,000 - 240,000; Full time

Benefits offered by this job

Annual leave

Health insurance

Retirement planning

LifeWorks Employee Assistance Program

Life assurance

Flexible country-specific benefits

Job summary

ICON Strategic Solutions is seeking an Audit Operational Specialist to support supplier quality activities for GMP suppliers and the Quality Management lifecycle.

You will contribute to QA/compliance, manage supplier changes/audits, and help ensure inspection-ready records while identifying risks and supporting batch release processes.

Qualifications

• Bachelor's degree in Life Sciences, Regulatory Affairs, or Compliance.
• Working knowledge of GMP requirements for biopharma and medical devices.
• Experience auditing GMP suppliers (e.g., CMOs).
• Experience with risk management and project management.
• Proven success in continuous improvement initiatives.
• 5+ years in healthcare products or related activities, incl. 4+ years GMP Quality/Compliance.

Responsibilities

• Quality assurance and compliance activities with deliverables.
• Manage Supplier Notifications of Change and New Supplier Requests.
• Support supplier audits and ensure inspection-ready quality records.
• Identify and mitigate risks; monitor quality metrics.
• Support GMP batch release activities and supplier identification.

Skills

Quality assurance

Supplier quality management

GMP auditing

Risk management

Project management

Education

Bachelor's degree in Life Sciences / Regulatory Affairs / Compliance

Job description

Audit Operational Specialist

At ICON Strategic Solutions, you will work in a sponsor-dedicated model, supported by ICON’s global expertise.

As the world’s largest FSP organisation, with over 90 sponsor partnerships, we offer stability, career development and a collaborative environment where your work contributes to the development of treatments that benefit patients worldwide.

As a Quality Assurance Specialist II at ICON, you will support the implementation and execution of supplier quality activities for GMP suppliers and provides support of the Quality Management lifecycle workstream, monitoring the compliance of R&D GMP suppliers

What You Will Do

You will contribute to quality assurance and compliance activities, taking responsibility for your deliverables and working collaboratively.

Key Responsibilities Include

• Primarily focuses on supplier quality management, compliance, and quality assurance support
• Manage Supplier Notifications of Change (SNCs), supports New Supplier Requests (NSRs) and supplier audits, ensures quality records are completed on time and remain inspection-ready,
• Proactively identifies and mitigates risks, monitors key quality metrics
• Medical Device Batch Release activities
• Supports executions of GMP audits and supplies identification and selection process

Your Profile

You will bring relevant quality assurance and compliance experience, along with the following qualifications and skills.

Required Qualifications And Experience

• Bachelor's degree in a related field (e.g., Life Sciences, Regulatory Affairs, or Compliance).
• Working knowledge of current Good Manufacturing Practice requirements for the biopharmaceutical and medical device industries
• Experience in supplier quality management and auditing GMP suppliers (e.g., CMOs)
• Experience with risk management strategies and general project management
• Proven success in identifying and implementing continuous improvement initiatives
• Minimum of 5 years professional working experience in the field of healthcare products or related activitiessuch aspharmaceuticalor devicemanufacturing, Quality Control or Quality Assurance including at least 4 years in GMP Quality or Compliance.
• Experience working in a global organization and effectively collaborating across functions, geographies, and cultures.

What ICON Can Offer You

Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our Benefits Examples Include

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs.
• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
• Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being.
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.

Visit our careers site to read more about the benefits ICON offers.

At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here