Manager, Quality Assurance

The Swiss based Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of pepTides and oligonucleoTides. As a full service provider Bachem offers products for clinical development and commercial applications as well as a comprehensive catalog and exclusive custom synthesis. With 50 years of experience and subsidiaries in Switzerland, the United States, the United Kingdom and Japan, Bachem is the partner of choice for the biotech and pharma industry worldwide.
Bachem. Leading Partner in Tides

In order to continue our organic growth, we are constantly looking for talent.

The Quality Assurance Manager of Manufacturing and Batch Compliance is responsible for operations related to Quality Assurance activities including the manufacturing floor quality oversight, GMP documentation and batch record review.

Your Tasks:

• Management of the assigned team
• Review and/or approval of master batch records and executed batch records
• Review and/or approval of technical protocols and reports
• Review and/or approval of quality records e.g. deviations, investigations, CAPA’s
• Responsible for evaluating shipment data loggers using Libero Manager software. Compile risk assessments in case of violating shipping conditions
• Ensure GMP compliance and continuous improvement of BTO’s quality system
• Responsible for ensuring and improving compliance of the assigned Manufacturing units
• Write/review/approve standard operating procedures (SOPs)
• Ensure timely and accurate production room and daily dispensary clearances

• Ensure timely and accurate GMP shipment clearances

• Support customer & regulatory audits. Participate in responses to audit observations.
• Review and/or approval of trending data
• Review and/or approval of Change Controls
• QA representative in project teams e.g. harmonization of systems and processes across Bachem sites, implementation of new systems or processes

Required:

• Bachelor’s Degree in Science related field, Chemical Engineering, Biology or equivalent
• Minimum of 5 years’ experience in a GMP/regulated industry
• Minimum of 3 years in QA management position
• Experience in GMP manufacturing environment, Quality Assurance, Quality Control
• Experience with 21 CFR Parts 210, 211, ICH Q7
• Experience with GMP document control
• Experience in both internal and external auditing
• Ability to work with regulatory agencies
• Strong technical writing skills
• Excellent written and oral communication skills
• Basic computer knowledge, including Microsoft Word, Excel and PowerPoint
• Ability to effectively organize, multitask, and work in a fast-paced, deadline driven work environment
• Ability to communicate in a proactive and solution-focused manner, including keeping management aware of potential issues
• Detail oriented with the ability to troubleshoot and resolve problems
• Ability to work independently and manage one’s time
• Communicate effectively and ability to function well in a team environment