Quality Compliance & Systems Operational Specialist

This is a fully remote position, open to applicants in Poland.

📋 Description

• Assist in the implementation and execution of quality activities for GMP suppliers.

• Aid in the Quality Management lifecycle workstream while overseeing the compliance of R&D GMP suppliers.

• Concentrate on supplier quality management, compliance, and providing quality assurance support.

• Oversee Supplier Notifications of Change (SNCs).

• Assist with New Supplier Requests (NSRs) and conduct supplier audits.

• Ensure that quality records are finalized promptly and remain ready for inspection.

• Proactively identify and address potential risks.

• Track key quality metrics.

• Carry out Medical Device Batch Release activities.

• Support the execution of GMP audits along with the processes for supplier identification and selection.

• Collaborate effectively and take ownership of deliverables.

⛳️ Requirements

• A Bachelor's degree in a relevant field (e.g., Life Sciences, Regulatory Affairs, or Compliance).

• Familiarity with current Good Manufacturing Practice standards for the biopharmaceutical and medical device sectors.

• Experience in supplier quality management and auditing GMP suppliers (e.g., CMOs).

• Knowledge of risk management strategies and general project management principles.

• Demonstrated success in identifying and executing continuous improvement initiatives.

• At least 5 years of professional experience in healthcare products or related areas such as pharmaceutical or device manufacturing, Quality Control, or Quality Assurance, including a minimum of 4 years in GMP Quality or Compliance.

• Experience in a global organization, effectively collaborating across various functions, geographies, and cultures.

• Legal eligibility to work in the country where the position is located.

🏝️ Benefits

• Competitive base salary along with performance-related incentives.

• Health and wellbeing programs including medical, dental, and vision coverage where applicable.

• Retirement and pension plans.

• Life insurance and disability coverage.

• Employee assistance programs and wellbeing resources.

• Opportunities for learning and development through structured training and career pathways.