QC Director, Biopharma Analytics & Compliance

GSK

Italia

On-site

EUR 140,000 - 190,000

Full time

2 days ago
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Job summary

GSK seeks a Quality Control Direct Director to oversee QC operations in the Parma Network Laboratory and lead analytical testing for the Parma site and Biopharm network. Responsibilities include planning resources, ensuring release, stability, validation, transfer testing, and coordination with R&D, Global QC, and manufacturing to support new product introductions.

This role leads a team of lab leaders, ensures ALCOA data practices, and drives continuous improvement, audits, and regulatory

Qualifications

  • Proven success leading a technical team across multiple functions.
  • Experience building and developing teams in a QC environment.
  • Strong written and verbal communication in cross-functional settings.
  • Ability to interact with peers and senior personnel in a multidisciplinary setting.
  • Capable of prioritizing actions to optimize laboratory outcomes.
  • Familiar with GMPs, NIH, ICH, FDA regulatory requirements for analytical testing.

Responsibilities

  • Oversee Analytical and Microbiology testing and release activities.
  • Coordinate analytical testing support for Parma site and Biopharm network, balancing priorities.
  • Provide technical guidance to laboratory supervisors and analysts.
  • Lead a team of lab leaders to ensure data generation and review per ALCOA.
  • Ensure timely laboratory and manufacturing investigations and CAPA closure.
  • Promote technical and professional growth within the QC team.
  • Ensure compliance with all SOPs, safety procedures and regulatory expectations.
  • Support product filings with regulatory agencies (INDs, BLA, MAA).
  • Represent QC in projects and committees within GSK.

Skills

Leadership
Team development
Communication skills
Interdisciplinary collaboration
Prioritization
GMP/Regulatory knowledge

Tools

Laboratory information systems
Electronic lab notebooks
Laboratory automation

Job description

GSK seeks a Quality Control Direct Director to oversee QC operations in the Parma Network Laboratory and lead analytical testing for the Parma site and Biopharm network. Responsibilities include planning resources, ensuring release, stability, validation, transfer testing, and coordination with R&D, Global QC, and manufacturing to support new product introductions.

This role leads a team of lab leaders, ensures ALCOA data practices, and drives continuous improvement, audits, and regulatory

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