About the role
- Develop quality system for CMC Quality Management
- Quality management of contract manufacturing organizations (CMOs)
- QA oversight of CMOs which includes periodic audits of CMOs and testing laboratories
- Establish and manage quality agreements
- Oversee quality processes relevant to outsourced activities
- Conduct quality risk assessments of CMOs
- Review and approve all quality records generated by CMOs
- Leadership as QA Head
- Train internal staff on CMO quality oversight practices
Requirements
- Must be educated to a BSc or higher within a Life-Sciences discipline or a related field with suitable industry experience
- Proven experience working at a senior level within Quality Assurance is a must
- Demonstrated experience building a Quality Management system would be preferred or at least management at a senior level
- CMC experience would be preferred ideally within a QA CMC role
- QA CMO management experience is a must
- Strong skills linked to aseptic/sterile products
- Fluency in English.
- We celebrate our differences and strive to create a workplace where each person can be their authentic self.
- We are committed to diversity, equity, and inclusion.
- Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits.
- With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
Quality Management SystemQuality AssuranceQuality Risk AssessmentAseptic ProductsSterile ProductsQuality AgreementsAuditingQuality Records ManagementContract Manufacturing OversightTesting Laboratories
Soft skills
LeadershipTrainingCommunication