Senior Specialist, Quality Control; Control Lead

As the site expands its footprint, introduces new Automated Storage Units (ASUs), and scales operations, our Quality team is growing rapidly. You will step in as the true co-owner of the GMP Change Control process, ensuring seamless strategic execution, robust impact assessments, and reliable quality standards.

Here, your voice matters. You will work alongside passionate scientists, engineers, and quality leaders who celebrate innovation, continuous learning, and direct mentorship.

• Own the Process:
  Drive the strategic development, governance, and end-to-end execution of QC change controls from initiation through implementation and closure.
• Be the SME:
  Represent QC Operations on local and global Change Control Boards and cross-functional forums.
• Champion Specifications:
  Support documentation and lifecycle management for clinical and commercial specifications (experience with specifications is a huge plus!).
• Navigate Fast-Paced Growth:
  Anticipate risks, prioritize under pressure, pivot quickly as volume ramps up, and partner across teams to build effective mitigation strategies.
• Continuous Improvement:
  Spearhead process enhancements, streamline templates, and support technical writing for SOPs, methods, and controlled documentation.

• Education:
  
  BS/BA in Life Sciences, Engineering, Regulatory, or a related discipline.
• Experience:
  
  5-8 years within the pharmaceutical or biotechnology sector.
• Change Control Expertise:
  Proven hands-on experience driving GMP change controls through complex life cycles (experience handling changes for specifications is highly desirable).
• Agility & Drive: A proactive problem-solver who remains composed under pressure and enjoys dynamic, fast-moving laboratory and manufacturing support environments.
• GxP Knowledge:
  Strong foundation in GMP, Good Documentation Practices (GDP), and Data Integrity standards.