We are seeking an exceptional Senior Quality Assurance (QA) Manager to join our client's esteemed team in Switzerland. As a Senior QA Manager, you will play a pivotal role in driving the highest standards of Quality Assurance across their Biotech manufacturing operations. You will lead and oversee all aspects of quality assurance activities, ensuring compliance with regulatory requirements, and fostering a culture of continuous improvement.
- Develop and implement comprehensive quality assurance strategies, policies, and procedures aligned with global regulatory standards, including GMP (Good Manufacturing Practice), GLP (Good Laboratory Practice), and ISO requirements.
- Provide strategic leadership and guidance to the QA team, ensuring effective execution of quality assurance activities and nurturing talent development.
- Establish and maintain robust quality management systems, including document control, change control, deviation management, and CAPA (Corrective and Preventive Actions) processes.
- Collaborate closely with cross-functional teams, including Manufacturing, R&D, and Regulatory Affairs, to drive quality-related initiatives and ensure alignment with company objectives.
- Conduct risk assessments and ensure appropriate controls are in place to mitigate quality risks throughout the product life cycle.
- Lead and support regulatory inspections and audits, ensuring compliance with regulatory requirements and timely resolution of findings.
- Stay abreast of evolving industry trends, regulatory changes, and technological advancements in quality assurance practices, providing recommendations for continuous process improvement.
- Oversee the review and approval of quality documentation, including SOPs (Standard Operating Procedures), protocols, reports, and batch records.
- Drive the implementation of effective quality metrics and data analysis techniques to monitor and improve product quality and process performance.
- Foster a culture of quality and continuous improvement, promoting awareness and understanding of quality assurance principles and best practices across the organization.
- Bachelor's or Master's degree in a relevant scientific discipline, such as Biology, Chemistry, or Pharmaceutical Sciences.
- Extensive experience (6+ years) in quality assurance within the Biotech or Pharmaceutical industry, with a strong understanding of GMP, GLP, and ISO regulations.
- Proven leadership and people management skills, with a successful track record of leading and developing high-performing QA teams.
- In-depth knowledge of quality management systems, quality control methodologies, and regulatory requirements.
- Experience in managing regulatory inspections and audits by health authorities.
- Strong analytical and problem-solving abilities, with attention to detail and a focus on data-driven decision-making.
- Excellent communication and collaboration skills, with the ability to influence and engage stakeholders at all levels of the organization.
- Proactive mindset, with the ability to anticipate and mitigate quality risks in a fast-paced, dynamic environment.
- Fluency in English; additional language skills are a plus.
Can this be interesting for you or anyone you know? If so, please apply here or contact Conor Kelly with your number/CV ASAP and he will give you a call.
?: +41 (0) 44 5514 407