Regional Quality and Compliance Senior Manager

6 days ago

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Sia Partners

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Banking • Energy & Environment • HR & Transformation • Manufacturing • Telecommunications

1001 - 5000 employees

Founded 2007

🏢 Enterprise

Description

• Establish and lead the EU Quality Assurance (QA) group within Latham BioPharm Group, Inc. • Report to the US Director of Global Quality Services. • Coordinate and lead all compliance (GxP) activities. • Initially involved with client deliverables/activities while building out the QA team. • Create compliance strategies and quality management systems. • Maintain appropriate documentation for GXP compliance. • Conduct audits for GXP compliance and perform due diligence assessments. • Build and manage the QA department in the EU location. • Report on compliance activities to client’s Leadership Team.

Requirements

• 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, 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.

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