Quality Assurance Manager for Drug Product
We are seeking an experienced Quality Assurance Manager to oversee compliance and customer quality agreement activities for Drug Product Visp. This role requires strong collaboration with cross-functional teams and external stakeholders to ensure regulatory compliance and quality assurance excellence.
Key Responsibilities:
1. Quality Agreements & Compliance:
* Establish, negotiate, and manage Quality Agreements (QAA) in close collaboration with Drug Product Services in Basel/Stein and Drug Substance sites.
* Act as the primary QA contact for customers, addressing all quality-related topics, complaints, deviations, changes, and technical inquiries.
2. Cross-Functional Collaboration & Project Support:
* Represent Quality Assurance in cross-functional teams, ensuring seamless collaboration with Manufacturing, QC, Support Functions, Project & Site Engineering for effective Drug Product processes.
* Act as a QA representative in technical transfer projects and customer meetings, ensuring compliance during new product introductions and project execution.
* Interface with customers regarding deviation reports, change requests, and other regulatory follow-ups.
3. Risk Management & Documentation Oversight:
* Support and approve project/product-specific risk assessments and regulatory gap assessments.
* Review and release critical product documentation, including process descriptions, workflows, manufacturing protocols, transfer documents, test plans, and parameter lists.
* Assess, review, and approve quality records such as deviations, change controls, CAPAs, investigations, and effectiveness checks in accordance with local GMP guidelines.
4. Continuous Improvement & Quality System Optimization:
* Support continuous improvement programs to enhance Quality Management Systems for Drug Product operations.
* Author, review, and approve GMP-relevant documents and SOPs, ensuring compliance with industry regulations.
Requirements:
5. Education:
* Bachelor's or Master's degree in Pharmaceutical Sciences, Chemistry, Biotechnology, or a related field.
6. Experience:
* 5-10 years of experience in Quality Assurance within the pharmaceutical or life sciences industry.
* Strong background in GMP compliance, technical transfers, and risk management.
* Proven experience in customer-facing QA roles and cross-functional collaboration.
7. Skills:
* Deep understanding of regulatory requirements, quality risk management, and GMP principles.
* Strong analytical, problem-solving, and negotiation skills.
* Ability to manage multiple projects in a fast-paced environment.
* Fluency in English is mandatory; German is a strong asset.
Benefits:
* The opportunity to drive key quality initiatives within a global pharmaceutical leader.
* A dynamic and collaborative work environment with significant opportunities for professional growth.
* Competitive contract conditions with the potential for extension.