Manager - Quality PQR, Poland

Eli Lilly and Company; Warszawa; On-site; PLN 169,000 - 255,000; Full time

Job summary

A leading global healthcare company in Warsaw is seeking a Quality Assurance Manager to oversee quality systems, manage supplier performance, and ensure compliance with regulations. The ideal candidate will have a Pharmacy master's degree, at least 2 years of experience in a pharmaceutical setting, and familiarity with quality management practices. This role offers opportunities for career growth and up to 20% travel.

Qualifications

• Minimum 2 years of work experience in a pharmaceutical wholesaler or pharmacy.
• Relevant certifications in GDP/GMP required.
• Valid professional licenses as per local regulations.

Responsibilities

• Implement and maintain the product quality system at the Polish affiliate.
• Collaborate with local regulatory authorities for compliance.
• Manage supplier performance and audits.

Skills

Quality management systems

Regulatory compliance

Supplier management

Analytical skills

Communication skills

Problem-solving

Education

Pharmacy master's degree

Tools

Quality management software

Job description

Overview

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

This position involves managing quality systems, collaborating with regulatory authorities, and overseeing supplier performance to maintain high standards of product safety and efficacy. The individual will work closely with various departments to ensure adherence to GDP/GMP regulations and support the overall quality assurance initiatives.

Responsibilities

• Product Quality Management: Implement and maintain the product quality system at the Polish affiliate, including local SOPs, deviation management, change control, corrective and preventive actions (CAPA), and product complaint management.
• Regulatory Interaction: Collaborate with local regulatory authorities to ensure compliance with current regulations and manage GMP/GDP inspections.
• Supplier Management: Ensure that service providers distributing products meet quality expectations and local regulations. This includes qualifying new suppliers, conducting regular audits, and managing supplier performance.
• Promotional Materials: Review and approve promotional materials that may directly impact product quality or patient safety.
• Sampling Programs: Manage physician sampling programs according to product quality requirements.
• Complaint Management: Ensure a process is in place for managing product complaints, including reports of suspected or tampered products.
• Staff Training: Implement a qualification program for staff involved in GMP/GDP activities.
• Quality Assurance Initiatives: Actively participate in quality assurance initiatives, including the implementation of local metrics reports and the review of Quality Agreements for GMP compliance.
• Product distribution: Play a crucial role in managing product launches and addressing issues such as mock recalls, shortages, and serialization errors.
• Documentation and Compliance: Manage documentation and compliance tasks, including updating the Quality Manual and ensuring adherence to regulatory requirements.
• Collaboration: Work closely with regional colleagues and supervisors to ensure alignment on quality standards and projects.
• Responsible Person (RP): Ensure good distribution practices are in place and adhered to. This includes overseeing the distribution quality system, managing recall activities, approving complaints, claims, and returns, and ensuring compliance with GDP rules and local law.

Basic Requirements

• Education Level: Pharmacy master degree.
• Experience: minimum 2 years of work experience in a pharmaceutical wholesaler or pharmacy
• Certifications: Relevant certifications in GDP/GMP.
• Licenses: Valid professional licenses as required by local regulations.
• Skills Testing: Proficiency in quality management systems and regulatory compliance.

Additional Skills/Preferences

• Previous experience in managing supplier quality and performance.
• Proficient in using quality management software and tools.
• Prior work with regulatory authorities and managing inspections.
• Proven ability to lead quality assurance initiatives and manage cross-functional teams.
• Strong analytical and problem-solving skills.
• Excellent communication and collaboration abilities.
• Ability to work independently and manage multiple tasks simultaneously.

Additional Information

• Travel: Up to 20% travel may be required for audits, inspections, and meetings.
• Shift Information: Standard business hours with occasional need for flexibility.
• Position Location: Poland.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

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