Quality Assurance Leader for Biologics QC and Analytics
vor 1 Monat
As a Quality Assurance Leader, you will be responsible for leading and managing a Clinical QC Phys-Chem analytical laboratory to ensure GMP compliant analytical testing of drug entities in different clinical development phases up to market authorization readiness.
You will maintain QC oversight of activities conducted within your team or cross teams in a matrix organization, dependent on process ownership, QC related deliverables and proactive risk and issue management.
Key Responsibilities:
- Lead and manage a Clinical QC Phys-Chem analytical laboratory including related equipment and supporting infrastructure.
- Maintain QC oversight of activities conducted within own team or cross teams in a matrix organization.
- Accountable to deliver QC work packages on time for customer projects.
- Ensure Key Quality Indicators and other quality metrics are adhered to by self and own team.
We are looking for an experienced leader with a strong background in quality assurance and control. Your expertise should include advanced working experience as a laboratory manager, preferably within a cGMP regulated area in the pharmaceutical or chemical industry.
You will also need to have proven track record to successfully lead and develop a team of scientists/laboratory analysts, technical knowledge on instruments used within Biologics QC, and hands-on experience in management of quality records like deviations, CAPAs, Change Requests.
Salary: $120,000 - $150,000 per year, depending on experience.
Additional requirements include a MSc or PhD degree in Biochemistry, Pharmaceutics, Chemistry or related field, business fluent written and spoken English, and hands on experience in digital laboratory workflows (e.g. electronic laboratory notebook, LIMS).
About Lonza
Lonza is a global leader in life sciences operating across three continents. We are dedicated to improving lives all around the world through innovative solutions in life sciences.
We offer a dynamic and challenging work environment where you can make a meaningful difference.
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