Senior Quality Assurance Manager - Camurus (Lund)

About this job

In this role, you will get the opportunity to work in a broad and independent quality position, close to both internal functions and external partners. Camurus is a rapidly growing and international company, and you will play an important role in ensuring quality and compliance throughout the supply and distribution network. Always with the patient in mind. We are looking for an experienced Senior Quality Assurance Manager to join our Quality organization at Camurus headquarters in Lund. This is a broad and independent role where you will work with quality assurance across Camurus' external supply and distribution network. You will have a key responsibility for quality agreements and quality aspects of supplier qualifications and monitoring, as well as for planning and conducting GDP and GMP audits. You will work closely with suppliers, distributors and other external partners, as well as with colleagues across the Camurus organization. The role combines hands-on quality work with a broader responsibility for ensuring that processes and external partners comply with Camurus' Quality Management System and applicable regulatory requirements. Your responsibility: · Independently review, establish, negotiate and maintain Quality Technical Agreements (QTAs) with suppliers and distributors. · Plan, conduct and document supplier qualifications and periodic supplier assessments. · Plan and lead GDP and GMP audits of suppliers, distributors and other quality-critical partners, as well as internal audits. · Lead deviation investigations, change controls, risk assessments and quality improvement initiatives. · Provide quality and compliance support to the organization in matters related to GDP, GMP and regulatory requirements. · Participate in regulatory inspections · Ensure that quality processes are developed, maintained and followed in accordance with the Camurus Quality Management System. · Collaborate cross-functionally with relevant internal functions and external partners. Candidate profile We are looking for an experienced quality professional with approximately 7–10 years of experience from the pharmaceutical industry. You hold an academic degree in Pharmacy, Chemistry, Biotechnology or another relevant Life Science discipline. You have solid experience from working in a regulated pharmaceutical environment and a strong understanding of GDP and/or GMP. Experience as a Responsible Person (RP) or Qualified Person (QP) is considered a strong merit. You have documented experience of planning, conducting and reporting supplier and GDP/GMP audits, as well as supplier qualification and ongoing supplier monitoring. You are also experienced in reviewing, negotiating and maintaining quality agreements with external partners. A solid understanding of European pharmaceutical legislation and regulatory requirements is essential. Good understanding of US regulations and/or experience of regulatory requirements outside the EU is considered a strong merit, and experience in areas complementing traditional pharmaceutical regulation, such as combination products, is considered an advantage. As a person, you are independent and confident in making decisions within your area of responsibility. You have high integrity and a pragmatic, yet quality-driven approach. You enjoy working in a dynamic environment with several parallel activities and are flexible enough to quickly adapt when priorities change. At the same time, you are collaborative and enjoy working cross-functionally across different parts of the organization. Fluency in spoken and written English is required. Camurus offers This is a great time to join a highly dynamic company during an exciting phase of growth. Camurus has been very successful in bringing pharmaceutical products to the market - and the ambitions are to continue in the same way. With a diversified project portfolio in different stages, the commercial potential is considerable. The position offers a broad and independent quality role with significant interaction across the organization and with external partners. You will have great opportunities to influence how Camurus works with quality and compliance as the company continues to grow internationally. Camurus has 300 employees with the headquarters located

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