Grifols

Senior Manager – Quality Operational Readiness

Grifols

full-time

Posted on:

Location Type: Office

Location: Parets del Valles • Montana • United States

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Job Level

Senior

About the role

  • Drive the implementation and operational readiness of Quality functions at new Biopharma manufacturing facilities across the EU, US, Canada, and other global locations.
  • Lead cross-functional quality teams, including Subject Matter Experts (SMEs), and collaborate closely with Engineering, Manufacturing, Regulatory Affairs, IT, and Global Quality.
  • Implement site-specific quality strategies, ensuring alignment with global policies and regulatory cGMP requirements (FDA, EMA, Health Canada, etc.).
  • Ensure readiness for regulatory inspections through comprehensive planning, mock audits, and gap assessments.
  • Conduct practice sessions with key site personnel to have successful interactions with regulatory inspectors.

Requirements

  • PhD in a Life Sciences, Chemical Sciences, or relevant degree (STEM degree preferred: science, biotechnology/technology, engineering, math, or computer science) with a minimum of 5 years relevant experience.
  • MS in a Life Sciences, Chemical Sciences, or relevant degree (STEM degree preferred: science, biotechnology/technology, engineering, math, or computer science) with a minimum of 7 years relevant experience.
  • BS in a Life Sciences, Chemical Sciences, or relevant degree (STEM degree preferred: science, biotechnology/technology, engineering, math, or computer science) with a minimum of 9 years relevant experience.
  • Strong grasp of quality risk-based processes and principles.
  • The position is eligible to participate in the company bonus pool.
  • There is a requirement for travel for this position. It is expected to have 15% to 50% travel to the other Biopharma sites in scope of support by Quality Operational Readiness. Some of this travel will be international travel.
Benefits
  • Medical
  • Dental
  • Vision
  • Life Insurance
  • PTO
  • Paid holidays
  • Up to 5% 401(K) match
  • Tuition reimbursement
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
quality risk-based processescGMP requirementsregulatory inspectionsmock auditsgap assessmentscross-functional team leadershipoperational readinessbiopharma manufacturingsite-specific quality strategiescollaboration with SMEs
Soft Skills
leadershipcollaborationcommunicationplanningorganizational skills