Full-Time Regional Quality & Compliance Senior Manager

This position will establish and lead the EU Quality Assurance (QA) group within Latham BioPharm Group, Inc. (Latham). It reports to the US Director of Global Quality Services.

Initial responsibilities include direct involvement with client deliverables/activities while building the QA team. Latham needs an individual to coordinate and lead all compliance (GxP) activities (including Disposition, SOP writing, auditing, SME for QA activities).

Latham has global offices, but employees work remotely. This role requires effective operation in a remote model to achieve compliance and team goals.

Experience requirements: At least 15 years of QA and compliance experience, ideally across multiple GxP areas, and all development stages.

Essential skills: Proven ability to lead and coordinate compliance activities, management, organization, and leadership skills. Ability to take a risk-based approach to compliance, manage long-term goals, and manage a departmental budget.

Candidate profile: Independent worker with excellent interpersonal skills, adaptable to a fast-paced, changing environment.

Responsibilities (Examples):

• Create robust compliance strategies in each GxP area, working with vendors and stakeholders.
• Create and maintain a quality management system for clients.
• Maintain and create SOPs for GxP compliance across all functions.
• Ensure client documentation supports compliance.
• Conduct, lead, or guide audits of internal and external parties.
• Perform due diligence assessments of external parties.
• Build and manage the EU QA department.
• Assist clients in managing compliance.
• Report compliance activities and corrective actions to client leadership.
• Chair quarterly Quality Meetings and generate minutes.
• Support and coordinate with the US team.
• Perform related duties, special projects, ad-hoc work as required.

Education and Experience: Bachelor's degree (technical emphasis preferred). Minimum 5 years' consulting experience; Minimum 15 years' experience in the pharmaceutical/biotechnology industry.

Skills:

• Travel up to 30%
• In-depth knowledge of cGXP and global regulatory requirements.
• Strong computer skills (SharePoint, DocuSign, PowerPoint, Excel, Outlook, Word).
• Proven leadership, communication (oral/written), and presentation skills.
• Effective interpersonal skills and conflict resolution.
• Teamwork skills and independent work ability.
• Attention to detail, flexibility, and awareness of production/quality issues.

Benefits:

• Supportive atmosphere
• Diversity, inclusion, and employee well-being
• Opportunities for innovation and growth
• Professional environment
• Clear goals for advancement
• Meritocratic promotion
• Competitive salary & benefits (flexible working, performance-related bonus, health & life insurance, pension, 27 days holiday).

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