Quality Assurance Expert with Regulatory Compliance
4 days ago
Job Overview
Lundbeck is seeking a Quality Assurance Professional to join its Corporate Product Quality Systems team. This role plays a vital part in maintaining high regulatory compliance while developing a business-driven quality function.
Your New Role
You will work in a department with diverse responsibilities and opportunities to influence job content based on interest and competencies. Through various activities, you will collaborate with production sites and suppliers across Lundbeck's global supply network.
We are looking for two new colleagues to replace open positions in the team. Your responsibilities will be a mix of:
- Supplier Management: Overseeing supplier management within packaging materials.
- Training Development: Developing and facilitating global and local trainings for the global quality system.
- Guideline Development: Creating global guidelines and procedures.
- Auditing: Conducting internal and external audits.
- Contact Person: Serving as a contact person for Lundbeck affiliates.
- GDP Responsibility: Managing GDP responsibility internally.
- GMP Review: Reviewing and approving GMP validation within IT systems.
- Operational Excellence: Participating in operational excellence projects to improve processes.
- Risk Register: Responsible for our internal Risk Register.
- Digital Projects: Engaging in projects involving digital cases.
Why this Opportunity?
This role offers a unique chance to influence and continuously improve core quality systems, ensuring alignment with the business strategy at Lundbeck. You will bring your experience from previous roles in the industry to significantly impact our quality system and processes.
Your Future Team
CORPORATE PRODUCT QUALITY SYSTEMS (CPQS) is a team of 12 highly skilled and competent colleagues. We are part of the CORPORATE PRODUCT QUALITY organization, which consists of about 200 employees.
The position is based in VALBY HQ, where you will report to the Vice President of CORPORATE PRODUCT QUALITY ASSURANCE. Some international travel is required. Our team has an international profile, and our daily language in the office is English.
What You Bring to the Team
You are a professional, self-driven, and experienced individual with the following skills and competencies:
- Academic Degree: Holding an academic degree in Pharmaceutical Sciences or Engineering.
- Work Experience: Having +4 years of relevant working experience within quality or manufacturing in the Pharmaceutical Industry.
- Analytical Mindset: Demonstrating a strong analytical mindset with a data-based approach.
- Operational Excellence: Experiencing Operational Excellence/LEAN.
- Curiosity: Showing curiosity towards colleagues, stakeholders, and business purpose.
- Adaptability: Adapting easily with changes in tasks, priorities, and processes.
- Accountability: Demonstrating accountability within your responsibilities.
Estimated Salary: The estimated salary range for this position is between $85,000-$110,000 per year, depending on qualifications and location.
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