One of the world's leading specialty Pharmaceutical companies is expanding their Combination Products business unit and is looking for an experienced specialist to join their growing Global team.
You will ensure that each of the 10 sites within the segment receives the right level of support to maintain and enhance GMP compliance, to solve quality-related service issues, to identify areas of improvement for quality operational performance in line with business needs and in accordance to company standards.
Key responsibilities of the Quality Compliance Specialist include:
- Input, Review, and Endorsement of Core Activities for Combination Products and Medical Devices Throughout Product Lifecycle: Development, Launch, and Commercialization
- Engage in Corporate Standards Processes
- Support the Implementation of the Site Inspection Readiness Program
- Notification of Escalation to Regulators; i.e. Field Alert Reports (FARs) and Rapid Alert Notifications (RANs)
- Participate and Evaluate Site Quality Council Performance Data and Areas of Risk
- Train Site Colleagues on the Corporate Standard System
- Review and Monitor the Quality Improvement Plans
- Foster and Promote Communication, Harmonization, and Support across Technology Segments
Key requirements of the Quality Compliance Specialist include:
- Formal education (BSc, MSc preferred) - medical engineering, medical technology, chemistry, microbiology, pharmacy, engineering, or related science-based degree
- Combination Products and/or Medical Devices SME
- 10+ years' experience as a functional leader with technical, team management, and operational responsibility
- Advanced hands-on practical knowledge in medical technology/engineering and Combination Product/Medical Device manufacturing
- Advanced knowledge of Combination Product/Medical Device-related current and upcoming legislation and industry best practices
- Effective negotiation skills, strong interpersonal skills, excellent presentation skills
- Fluent English required, further languages beneficial
