Quality Lead

Direct message the job poster from Gi Group

Senior Recruitment Consultant at Gi Life Sciences

Job Purpose

• Lead complex projects and quality initiatives.
• Lead a small sub-team as part of a matrix (if applicable).
• Provide expertise in specific quality areas.
• Lead, guide, and support global TRD project teams in all quality-relevant topics, questions, and issues.
• Develop project strategies in alignment with TRD, considering all relevant cross-functional aspects to ensure the quality of deliverables.
• Act as QA representative at expert panels.
• Lead QA aspects of new technology projects.
• Represent QA in complex due diligence projects.
• Lead PAI and submission preparations; ensure inspection site readiness.

Main Activities

• Lead and support global TRD project teams; represent TRD QA globally in TRD sub-teams, global quality board meetings, and project development gate meetings.
• Ensure quality oversight on assigned development projects with strong quality guidance and scientific/technical expertise.
• Contribute to project strategy, including contingency planning and risk assessments, to ensure timely achievement of quality deliverables. Ensure alignment with TRD QA strategies and compliance with cGMP guidelines and internal procedures.
• Manage interactions between TRD QA and other departments, both within and outside TRD.
• Communicate overall project strategy, key issues, and other critical topics proactively and in a timely manner to relevant stakeholders and management.
• Represent TRD QA in due diligence teams; provide timely quality assessments of potential in-licensing products and support follow-up activities.
• Provide input for contracts and QA agreements with third parties; approve project-specific QA agreement amendments.
• Lead or participate in global and/or cross-functional initiatives.
• Prepare and guide TRD project teams for Mock-PAI and PAI within the submission and inspection preparation process.
• Coach and mentor functional experts; participate in the recruiting process.

Additional Specific Tasks / Roles

• Responsibilities, approval, and release authorities as described in SOP-5003834.
• QA support for portfolio projects related to:
• Medical Devices / Drug-Device Combination products (21 CFR 820 / CFR Part 4, ISO 13485)
• Software as a Medical Device (SaMD)
• Integration of BD&L projects / due diligence as needed.
• Quality oversight of assigned development and commercial SaMD projects.
• Initiate, lead, or contribute to interface meetings with Device Development line units for GMP/QMS topics and continuous process improvements.

Ideal Background

Education

• Bachelor’s degree with 10 years of experience in pharmaceutical quality or operations, or
• Master’s degree with 5 years of experience in pharmaceutical quality or operations.

Languages

• Good command of local site language (oral) preferred.

Experience / Professional Requirements

• Fundamental and broad knowledge of quality standards in Drug Substance, Drug Product, and Medical Devices manufacturing and control.
• Experience with FDA and EMA inspections.
• Familiarity with RegCMC requirements for Health Authority submissions (INDs, IMPDs, NDAs, ANDAs, MAAs).
• Broad experience in technical drug development and QA/QC departments.
• Preferably experience in Technical Operations or equivalent role from an external company.
• Proven success in leading interdisciplinary teams within TRD or other technical/methodological functions.
• Strategic thinking, strong quality awareness, and implementation capabilities in matrix teams.
• Computer literacy in MS Office and document management systems, with a readiness to learn new systems.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Contract

Job function

• Job function

  Quality Assurance

• Industries

  Pharmaceutical Manufacturing

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