Regional Quality and Compliance Senior Manager - Remote

Overview

This position will be required to establish and lead the EU Quality Assurance (QA) group within Latham BioPharm Group, Inc. (Latham). This position will report to the US Director of Global Quality Services. Initially, this role will be directly involved with client deliverables/activities while building out the QA team.

In Short

• Establish and lead the EU Quality Assurance group.
• Coordinate and lead all compliance (GxP) activities.
• Create robust compliance strategies in each GXP area.
• Maintain a quality management system for clients.
• Conduct audits of internal and external parties.
• Build and manage the QA department at the EU location.
• Report on compliance activities to client’s Leadership Team.
• Chair quarterly Quality Meetings.
• Support and coordinate with the US team’s clients.
• Perform related duties and special projects as required.

Requirements

• Bachelor's degree in a scientific or engineering field preferred.
• Minimum of 15 years of experience in the pharmaceutical or biotechnology industry.
• 5 years prior consulting experience.
• In-depth knowledge of cGXP and global regulatory requirements.
• Computer skills in SharePoint, DocuSign, PowerPoint, Excel, Outlook, and Word.
• Excellent oral and written communication skills.
• Ability to work independently and in a team.
• Attention to detail and flexibility.
• Travel up to 30%.

Benefits

• Supportive atmosphere encouraging innovation.
• Commitment to diversity and employee well-being.
• Opportunities for personal development.
• Competitive salary in line with the market.
• Flexible working arrangements.
• Performance-related bonus.
• Health and Life insurance.
• Employer-matched contribution pension scheme.
• 27 days holiday per year, plus Bank Holidays.