Sr Manager Software Developer Validation Quality Professional

1 month ago


Nutley, United States Stealth Full time

Essential Functions

Quality Assurance approver for internal computer system validation efforts. Act as liaison to the business for guidance and consultancy on system validation. Support computer system audits for review of SDLC and data integrity controls. Review CAPA and verification of CAPAs of system audits. Support health authority audits/inspections for inspection readiness.


Requirements

  • Bachelor’s degree in associated functional disciplines including IT, Data Sciences and others.
  • Software development familiarity with both Agile and Waterfall methodology.
  • Knowledge of coding matrix and complexity measurements/determination.
  • Minimum 8 years’ experience in the pharmaceutical industry or similar.
  • Familiarity with regulations governing software development and validation.
  • Knowledge of Statistical Programming is preferred but not required.
  • Knowledge of GCP/GMP is preferred.
  • Auditing experience is preferred but not required.
  • Must have professional communications skills, strong independent time management skills and the ability to manage multiple projects concurrently.
  • Ability to Travel (approximately 10-20%).
  • Location: Nutley (hybrid role)


Must have skills

  • CAPA
  • Developed software and software process
  • CSV audit
  • GCP/GMP
  • CSV testing
  • Agile, Waterfall methodology experience
  • Can come from cro, medical labs, pharma
  • Travel 10-20%
  • Not just a tester, will be a creator and writer
  • No job jumpers, MUST Have Tenure
  • 8 years’ experience minimum


  • No Visa candidate
  • Candidates must reside within an hour of Nutley NJ. Other acceptable locations besides New Jersey are NY, PA areas
  • commutable to Nutley
  • Salary-200K-225K Annually
  • Benefits- Full Suite
  • PTO
  • Paid Holidays
  • US Citizen 0r Green Card Holder
  • 401K
  • Hybrid Role


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