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.

Initially, this role will be directly involved with client deliverables/activities while building out the QA team.

Latham seeks a candidate to coordinate and lead all compliance (GxP) activities (including Disposition, SOP writing, auditing, and SME for QA activities).

The role requires at least 15 years of experience in QA and compliance, ideally across multiple GxP areas, and at all stages of development.

Essential skills include management, organization, leadership, risk-based compliance approach, long-term goal management, and departmental budget management.

Candidates must be independent workers with strong interpersonal skills, adaptable to fast-paced environments with shifting priorities.

Responsibilities:

• 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 to support GxP compliance across functions.
• Ensure clients have appropriate documentation for compliance.
• Conduct, lead, or guide audits 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 and corrective actions to client leadership (potentially developing dashboards).
• Chair quarterly Quality Meetings and generate minutes.
• Support and coordinate with the US team's clients.
• Perform related duties, special projects, ad-hoc work, and other functions as required.

Education:

• Bachelor's degree in a scientific or engineering field preferred.

Required Experience and Skills:

• 5+ years prior consulting experience.
• 15+ years experience in the pharmaceutical/biotechnology industry.
• Experience in product development and regulatory affairs.
• Effectiveness in approaching and solving technical problems.
• Ability to engage clients remotely.
• In-depth knowledge of cGxP and global regulatory requirements.
• Competency in SharePoint, DocuSign, PowerPoint, Excel, Outlook, and Word.
• Strong leadership, oral, and written communication skills (presentations, interpersonal skills, conflict resolution).
• Teamwork and independent work skills.
• Attention to detail, flexibility, and awareness of production/quality control issues.
• Travel up to 30%

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