Regional Quality and Compliance Senior Manager

Summary

Join Latham BioPharm Group, Inc. as the EU Quality Assurance (QA) group leader, reporting to the US Director of Global Quality Services. Initially, you will directly contribute to client deliverables while building the QA team. This role requires coordinating and leading all GxP compliance activities, including SOP writing, auditing, and acting as a subject matter expert. The position demands at least 15 years of QA and compliance experience across multiple GXP areas and development stages. You will be responsible for creating compliance strategies, maintaining quality management systems, conducting audits, and building the EU QA department. Latham offers a supportive atmosphere, flexible working arrangements, and various benefits.

Requirements

• Bachelor's degree. Technical emphasis in an appropriate scientific or engineering field preferred
• A minimum of 5-years prior consulting experience
• Travel up to 30%
• Minimum of 15 years of experience in the pharmaceutical or biotechnology industry, with a focus on product development and regulatory affairs
• Effectiveness and creativity in approaching and solving technical problems
• Ability to engage clients in a remote setting through scheduled calls and meetings
• In-depth working knowledge of cGXP and of global regulatory requirements
• Computer skills; competency in SharePoint, DocuSign, PowerPoint, Excel, Outlook and Word
• Evidence of leadership skills coupled with highly developed oral and written communication skills, i.e., effective presentation of concepts and ideas, as well as interpersonal and conflict resolution skills
• Demonstrated teamwork skills and ability to work independently
• Attention to detail, flexibility and an awareness of production and quality control problems

Responsibilities

• Create robust compliance strategies in each GXP area, working with vendors (both CXOs and QA providers), and internal/external stakeholders
• Create and maintain a quality management system for clients
• Maintain (and create where needed) SOPs and other documentation to support GXP compliance across all functions for clients
• Ensure clients have appropriate documentation or other systems in place to maintain appropriate compliance in all functions
• Conduct, lead or guide audits of internal and external parties as required for GXP compliance
• Perform due diligence assessments for external parties
• Build and manage the QA department at the EU location
• Assist clients in managing compliance
• Report on compliance activities, corrective actions (as needed) to members of the client’s Leadership Team as needed (potentially developing dashboards / summaries)
• Chair quarterly Quality Meetings and generate minutes
• Support and coordinate with the US team’s clients for overseas requirements and audits
• Perform related duties, special projects, ad-hoc work and/or other functions as required by the line manager

Benefits

• A supportive atmosphere, where innovation and initiative are encouraged
• A commitment to diversity, inclusion and employee well-being
• Opportunities to flex your intellectual and creative muscles
• Welcoming, friendly and professional colleagues
• A personal development plan with clear goals for advancement
• A meritocratic approach to promotion that rewards those who exceed expectations
• A competitive salary, in line with the market and your peers
• Flexible working arrangements
• A performance-related bonus
• Health and Life insurance
• An employer-matched contribution pension scheme
• 27 days holiday per year, plus Bank Holidays