Affiliate Quality Manager

📌 Core Information 🔹 Job Title: Affiliate Quality Manager 🔹 Company: Viatris 🔹 Location: Tatabánya, Komárom-Esztergom, Hungary 🔹 Job Type: Full-time 🔹 Category: Pharmaceutical Wholesale 🔹 Date Posted: May 25, 2025 🚀 Job Overview Key aspects of this role include: - Leading the quality assurance department of the pharmaceutical wholesale unit - Ensuring compliance with GDP, relevant regulations, and Viatris procedures - Managing the quality management system, documentation, training, quality complaints, and acting as the primary contact for local authorities - Collaborating with various departments to maintain high-quality standards and ensure regulatory compliance - Demonstrating strong leadership skills, attention to detail, and the ability to work independently ASSUMPTION: This role requires a proactive and detail-oriented individual who can effectively manage multiple responsibilities and ensure the quality and safety of pharmaceutical products. 📋 Key Responsibilities ✅ Lead the quality assurance department and ensure compliance with GDP, relevant regulations, and Viatris procedures ✅ Manage the quality management system, documentation, training, quality complaints, and local authority interactions ✅ Collaborate with various departments to maintain high-quality standards and ensure regulatory compliance ✅ Demonstrate strong leadership skills, attention to detail, and the ability to work independently ASSUMPTION: The successful candidate will have a strong background in quality assurance, regulatory compliance, and leadership within the pharmaceutical industry. 🎯 Required Qualifications Education: - Pharmacy degree Experience: - Minimum 1 year of wholesale experience - 5 years of experience in the pharmaceutical industry (GMP/GDP environment preferred) Required Skills: - Knowledge of GDP and relevant regulations - Leadership experience - Independent work and problem-solving skills - Conflict management and communication skills - Knowledge of TrackWise, SAP, and ORCA systems (preferred) - English proficiency (B2 level or higher) - Driving license (B category) Preferred Skills: - Knowledge of European regulations - Additional language proficiency (e.g., Hungarian) ASSUMPTION: Candidates with additional relevant experience or certifications may be preferred. 💰 Compensation & Benefits Salary Range: €35,000 - €45,000 per year (based on experience and industry standards) Benefits: - Competitive salary and benefits package - Comprehensive health insurance - Retirement savings plan - Employee assistance program - Training and development opportunities - Flexible working hours and remote work options Working Hours: Full-time (40 hours per week) ASSUMPTION: The salary range is estimated based on industry standards for a role of this level and experience requirements. The actual salary may vary depending on the candidate's qualifications and the company's internal policies. 📌 Applicant Insights 🔍 Company Context Industry: Pharmaceutical Wholesale Company Size: 10,001+ employees (global) Founded: 2000 (as a result of the merger of Pfizer and Wyeth) Company Description: Viatris is a global healthcare company empowering people worldwide to live healthier at every stage of life. They provide high-quality, trusted medicines and innovative solutions to improve patient health. Company Specialties: Pharmaceutical manufacturing, wholesale, and distribution; biotechnology; vaccines; animal health; and consumer healthcare. Company Website: Viatris Connect ASSUMPTION: Viatris is a large, multinational corporation with a strong focus on innovation, quality, and regulatory compliance. They operate in a highly regulated environment and prioritize the safety and efficacy of their products. 📊 Role Analysis Career Level: Mid-level to senior Reporting Structure: Reports directly to the Quality Assurance Manager or similar role Work Arrangement: On-site, full-time (40 hours per week) with potential remote work options Growth Opportunities: - Career progression within the quality assurance department or related roles - Opportunities to gain experience in different aspects of pharmaceutical manufacturing and distribution - Potential to work on international projects and collaborate with global teams ASSUMPTION: This role offers opportunities for career growth and development within the quality assurance department and the broader pharmaceutical industry. 🌍 Location & Work Environment Office Type: Corporate office with a dedicated quality assurance department Office Location(s): Tatabánya, Komárom, and potentially other locations within Hungary Geographic Context: - Tatabánya: A city in the Komárom-Esztergom county, located approximately 40 km northwest of Budapest - Komárom: A city in the Komárom-Esztergom county, located on the Danube River, approximately 70 km northwest of Budapest Work Schedule: Monday to Friday, 8:00 AM to 4:30 PM (with a 30-minute lunch break) with potential flexibility for remote work ASSUMPTION: The work environment is dynamic and collaborative, with a strong focus on teamwork and communication. The location offers easy access to major highways and public transportation options. 💼 Interview & Application Insights Typical Process: 1. Online application submission 2. Phone or video screening 3. In-person or virtual interview with the hiring manager and/or team members 4. Final interview with the Quality Assurance Manager or similar role 5. Background check and offer Key Assessment Areas: - Technical knowledge and experience in quality assurance and regulatory compliance - Leadership skills and ability to manage a team - Problem-solving and decision-making abilities - Communication and interpersonal skills - Cultural fit and alignment with company values Application Tips: - Tailor your resume and cover letter to highlight relevant experience and skills for this role - Prepare for behavioral interview questions that focus on your problem-solving skills, leadership experience, and ability to work in a regulated environment - Research Viatris and the pharmaceutical industry to demonstrate your enthusiasm and understanding of the role ATS Keywords: Quality Assurance, Pharmaceutical Wholesale, GDP Compliance, Regulatory Affairs, Leadership, Problem Solving, Communication, Team Management, Pharmaceutical Industry ASSUMPTION: The interview process will focus on assessing your technical knowledge, leadership skills, and cultural fit for the role and the company. 🛠️ Tools & Technologies - TrackWise (Quality Management System) - SAP (Enterprise Resource Planning) - ORCA (Order-to-Cash) - Microsoft Office Suite (Word, Excel, PowerPoint) - Project management tools (e.g., Asana, Jira) ASSUMPTION: The successful candidate will have experience with relevant quality management systems, enterprise resource planning software, and project management tools. 👔 Cultural Fit Considerations Company Values: - Integrity: Upholding the highest ethical standards and acting with honesty and transparency - Excellence: Pursuing continuous improvement and delivering high-quality results - Caring: Demonstrating empathy, respect, and a commitment to improving the lives of patients and communities - Collaboration: Working together to achieve common goals and drive innovation - Inclusion: Fostering a diverse and inclusive work environment that values the unique perspectives of all employees Work Style: - Results-driven and focused on delivering high-quality products and services - Collaborative and team-oriented, with a strong emphasis on communication and coordination - Adaptable and responsive to change, with a focus on continuous learning and improvement - Committed to maintaining a safe and efficient work environment that prioritizes the well-being of employees and patients Self-Assessment Questions: 1. How do you ensure the quality and safety of pharmaceutical products in a wholesale setting? 2. Can you describe a time when you had to manage a team to resolve a complex quality issue? 3. How do you stay up-to-date with changes in regulations and industry best practices related to pharmaceutical wholesale? 4. How do you balance the need for thorough documentation and the efficient processing of wholesale orders? 5. Can you provide an example of a time when you had to collaborate with local authorities to resolve a regulatory compliance issue? ASSUMPTION: Viatris values employees who are passionate about improving patient health, committed to delivering high-quality products, and dedicated to fostering a collaborative and inclusive work environment. ⚠️ Potential Challenges 1. Managing a team with varying levels of experience and expertise in quality assurance and regulatory compliance 2. Ensuring the timely resolution of quality issues while maintaining high-quality standards and regulatory compliance 3. Balancing the need for thorough documentation with the efficient processing of wholesale orders 4. Navigating the complexities of the pharmaceutical regulatory environment and staying up-to-date with changes in regulations and industry best practices 5. Collaborating effectively with local authorities and other external stakeholders to ensure regulatory compliance and maintain a positive reputation for the company ASSUMPTION: The successful candidate will be able to overcome these challenges by leveraging their strong leadership skills, technical expertise, and ability to work effectively in a dynamic and collaborative environment. 📈 Similar Roles Comparison 1. Affiliate Quality Manager vs. Quality Assurance Manager: - Both roles focus on ensuring the quality and safety of pharmaceutical products, but the Affiliate Quality Manager is specifically responsible for the wholesale unit, while the Quality Assurance Manager oversees quality assurance across the entire organization. - The Affiliate Quality Manager reports directly to the Quality Assurance Manager or similar role, while the Quality Assurance Manager reports to the Vice President of Quality or similar role. 2. Affiliate Quality Manager vs. Regulatory Affairs Manager: - Both roles require a strong understanding of regulatory compliance, but the Affiliate Quality Manager focuses on ensuring compliance within the wholesale unit, while the Regulatory Affairs Manager is responsible for maintaining the company's compliance with all relevant regulations and guidelines. - The Affiliate Quality Manager works closely with the Regulatory Affairs Manager to ensure that wholesale operations remain compliant with all relevant regulations. ASSUMPTION: The Affiliate Quality Manager role is a critical component of Viatris' quality assurance and regulatory compliance efforts, requiring a unique blend of technical expertise, leadership skills, and industry knowledge. 📝 Sample Projects 1. Developing and implementing a new quality management system for the wholesale unit to improve efficiency and ensure regulatory compliance 2. Conducting a comprehensive review of wholesale operations to identify and address potential quality and safety issues 3. Collaborating with local authorities to resolve regulatory compliance issues and maintain a positive reputation for the company 4. Leading a team to develop and implement a new training program for wholesale employees to improve their understanding of quality assurance and regulatory compliance 5. Conducting regular audits of wholesale operations to ensure ongoing compliance with GDP, relevant regulations, and Viatris procedures ASSUMPTION: These sample projects demonstrate the diverse range of responsibilities and challenges faced by the Affiliate Quality Manager, requiring a strong combination of technical expertise, leadership skills, and problem-solving abilities. ❓ Key Questions to Ask During Interview 1. What are the biggest challenges facing the quality assurance department in the next 1-2 years, and how can this role help address them? 2. How does the company support the professional development and growth of employees within the quality assurance department? 3. Can you describe the company's approach to collaboration and communication between the quality assurance department and other departments within the organization? 4. How does the company ensure the accuracy and completeness of documentation related to quality assurance and regulatory compliance? 5. What are the key priorities for this role in the first 3-6 months, and how will they be measured and evaluated? ASSUMPTION: Asking these questions will help you better understand the role's responsibilities, the company's priorities, and the opportunities for professional growth and development. 📌 Next Steps for Applicants To apply for this position: 1. Submit your application through this link 2. Tailor your resume and cover letter to highlight your relevant experience and skills for this role, with a focus on quality assurance, regulatory compliance, and leadership 3. Prepare for behavioral interview questions that focus on your problem-solving skills, leadership experience, and ability to work in a regulated environment 4. Research Viatris and the pharmaceutical industry to demonstrate your enthusiasm and understanding of the role 5. Follow up with the hiring manager or HR representative within 1 week after your interview to express your interest in the position and reiterate your qualifications ⚠️ This job description contains AI-assisted information. Details should be verified directly with the employer before making decisions.