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Quality R&D analytical labs Associate Director @1925 GlaxoSmithKline LLC

[Hiring] Quality R&D analytical labs Associate Director @1925 GlaxoSmithKline LLC

Mar 27, 2025 - 1925 GlaxoSmithKline LLC is hiring a remote Quality R&D analytical labs Associate Director. 💸 Salary: competitive salary and annual bonus. 📍Location: USA.

This description is a summary of our understanding of the job description. Click on 'Apply' button to find out more.

Role Description

This role involves serving as a compliance authority to ensure quality oversight and compliance within the Analytical Development team, supporting development and GMP analytical activities at US sites.

  • Ensure lab activities are conducted in accordance with GMP, local, corporate, and relevant international regulations.
  • Foster a culture of continuous improvement and compliance.
  • Manage stakeholder relationships to ensure effective communication with global R&D and maintain a unified quality voice with Quality teams.
  • Act as a compliance authority, providing fit-for-purpose quality oversight and maintaining quality standards from method development to release testing by performing Gemba walks, coaching, and reviewing critical documents.
  • Oversee Deviation, Corrective and Preventive Actions (CAPA), and Change Control processes, and perform operational quality oversight on laboratory operations.
  • Manage and escalate issues appropriately to ensure timely and effective resolution, and drive quality initiatives to foster a quality culture and mindset.
  • Ensure quality practices are fit-for-purpose and aligned across all supported analytical departments, providing risk-proportioned quality input to processes and systems.
  • Perform shared quality activities linked to the site, such as Management Monitoring review and audit facilitation.
  • Support local and global QR&D projects, such as R&D QMS implementation.
  • Prepare and support the R&D functions for audits conducted by GSK and/or external Health Authorities.

Qualifications

  • University (Master) degree in sciences or equivalent, analytical expertise.
  • 8+ years of experience in a quality or compliance role within the pharmaceutical or biotechnology industry, with a focus on R&D.
  • Knowledge in quality regulation requirements covering GMP and general quality compliance.
  • Experience in managing and leading quality activities in an R&D environment, including audit facilitation and quality system implementation.

Requirements

  • Strong interpersonal skills with an ability to enable and drive change.
  • In-depth knowledge and expertise of quality systems, especially of key/core, such as Deviation/Investigation, Documentation Management, Training, Change Control, CAPA, Product Disposition, Validation.
  • Ability to manage networks and build relationships transversally across the network.
  • Experience of working with multi-functional teams.
  • Excellent oral and written communication skills.
  • Problem identification and solving skills.
  • Flexible thinking and risk-based approach methodology adept.
  • Proven experience in managing and leading quality activities in an R&D environment, including audit facilitation and quality system implementation.
  • Excellent problem-solving skills and the ability to make data-driven decisions.
  • Ability to adapt, work under uncertainty and accommodate flexible work demands.

Benefits

  • Competitive salary
  • Annual bonus based on company performance
  • Healthcare and wellbeing program
  • Pension plan membership
  • Shares and savings program
  • Hybrid working model through the Performance with Choice program

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Back to Remote jobs  >   All others
Quality R&D analytical labs Associate Director @1925 GlaxoSmithKline LLC
All others
Salary 💸 competitive salary and annual bonus
Remote Location
USA
Job Type full-time
Posted Mar 27, 2025
Apply for this position Unlock 54,756 Remote Jobs
📍 Be aware of the location restriction for this remote position: USA
Beware of scams! When applying for jobs, you should NEVER have to pay anything. Learn more.
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