Senior Quality Assurance Manager
A globally renowned pharmaceutical company is seeking to recruit a Senior Quality Assurance Manager to their office in Switzerland. The organisation works across a range of industries, from medical devices to pharmaceutical and consumer goods, and operates in over 60 countries. This position offers an exciting opportunity to work with a prestigious and historic pharmaceutical establishment and provide real regulatory expertise.
- Overseeing and managing the execution of Quality Systems (QS) at site level, including:
- Nonconformances (NC)
- Corrective and Preventive Action (CAPA)
- Internal Audit (IA) Observations
- Site Complaint Manufacturing Investigations
- Product Quality Escalation, Quality Progress Review (QPR)
- Quality System Management Review (QSMR)
- Other assigned QS activities to ensure systems are effective and in compliance
- Managing the performance and communication of QS metrics at the site level.
- Ensuring site readiness in the deployment of QS initiatives.
- Supporting compliance and document control areas, and continuous improvement of the Quality System.
- Responsibilities are for a site that is complex or has a demanding compliance profile.
Skills and Requirements:
- Degree in Engineering is preferred or associated relevant Scientific / Technical / Quality discipline.
- 6 years of related experience in Medical Device or Pharmaceutical environment or equivalent combination of education and experience is required.
- Knowledge of ISO and QSR regulations is required.
- Experience with root cause investigation, change management, risk management and technical writing is required.
- Experience in working in a manufacturing/operations environment is preferred.
- Experience in Quality Auditing and notified body inspections is preferred.
- Experience in Quality Systems process development, support, integration or enhancement is preferred.
- Experience in Project Management is preferred.
- A certification in process excellence is preferred.
- Advanced use of computer and software applications is required.
- Experience with training or coaching others is required.
- Direct supervision experience is preferred Interpersonal.
- Strong communication, influencing and leadership skills.
- Ability to communicate at all levels of the organisation, and to interact with and influence cross-functional and cross-business teams to drive results is required.
- Strong business acumen, interpersonal skills relating to teams with diverse cultures and business practices is required.
- Strategic and tactical execution abilities, including strong organisational skills, is required.
- Ability to take initiative regarding innovative approaches to problem-solving in a fast-paced, changing business environment is required.
- Fluent in German and English.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please Caleb Mensah at 0203 854 1080 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.