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Senior Manager, Biopharma IT Quality Assurance

2 months ago

Reston, Virginia, United States Laguna Source Full time
Job Summary

Laguna Source is seeking a highly experienced Senior Manager, Biopharma IT Quality Assurance to lead our newly established IT QA group within a cutting-edge biologics manufacturing facility. As part of a leading Global Contract Manufacturing Organization (CMO), you will be responsible for overseeing the digitalization efforts and ensuring consistency with GMP and site Quality policies.

Key Responsibilities
  • Establish and train a new team on the requirements of Digital Quality systems and functions.
  • Develop a framework for integrating QA oversight into routine business and operational processes within the organization.
  • Lead involvement in change management, automation improvements, system upgrades, and establishment of routine processes (e.g., audit trail reviews).
  • Drive the implementation of Quality Management Systems and plant initiatives related to digital Quality.
  • Serve as an IT QA Subject Matter Expert in regulatory inspections and audits.
  • Ensure compliance with relevant regulations and guidance for data integrity.
  • Oversee computer system validation processes and documentation.
  • Develop and implement SOPs and quality documentation within cGMP compliance.
Requirements
  • BS or MS in Computer Sciences, Engineering, Mathematics, or a technology-related field.
  • At least 5 years of experience working in a similar leadership role in Automation/IT/QA/CSV within the BioPharma, BioPharmaceutical, Pharmaceutical, or Biotechnology industry.
  • Experience working within a major Biologics CDMO/CMO environment.
  • Deep knowledge and understanding of relevant regulations and guidance for data integrity.
  • Familiarity with computer system validation processes and GAMP guidelines.
  • Exceptional project management skills and experience working in multi-departmental teams or task forces.
  • Expertise in Quality Management Systems, including Electronic Data Management Systems (EDMS), Electronic Quality Management Systems (EQMS), and Laboratory Information Management Systems (LIMS).
  • Strong understanding of cGMP compliance and GMP documentation practices.
  • Excellent communication and leadership skills.
What We Offer
  • Competitive base salary, target bonus, retirement allowance, and excellent medical benefits.
  • Company-paid luxury apartment in Songdo.
  • International school tuition paid for children at the top rate Chadwick International School in Songdo.
  • Company-paid airfares to visit the US (or country of origin).
  • 3 weeks of vacation time.
  • Opportunity to rapidly advance your career within the World's Largest Biologics CMO.
  • Work alongside a friendly team of over 100 US Expats and live within the amazing Songdo international community.
  • Opportunity to live and work in the ultramodern New Songdo city with excellent restaurants and an abundance of shopping.