Job summary
Ensures plant systems batch release, and/or relevant quality processes are compliant with regulations.Responsible for quality oversight, review & approval of validation activities and documents.Supports audits & inspections and performs self-audits.
Job seniority: mid-to-senior level
Responsibilities
• Make decisions on quality & compliance issues with little guidance• Participate in process group activities as assigned & leads local implementations• Ensure site compliance with regulations, standards, and SOPs• Lead improvement activities/improvement of standards within the assigned process• Review & approve change control documentation, SOPs, and other cGMP documentation• Provide coaching to site regarding quality & compliance related activities• Support, review & approve complex cross-functional investigations & root-cause analysis• Facilitate sharing of regulatory & compliance expectations• Review & approve complex DVs, CRs, trend & report data for CAPA, QMRs & APR reports• Eliminate non-value-added practices
Requirements
• High School Diploma or equivalent (GED) required• Bachelor's degree in Life Sciences or relevant field preferred• Minimum of seven (7) years of QA and/or related quality experience required• Demonstrated expertise in Regulations & quality systems preferred• Quality Risk Management experience required• Experience with regulatory requirements computer system required• Experience in use of Risk Assessment & Vendor Assessments required• Expert in cGMP documentation practices preferred• Excellent troubleshooting skills required• Demonstrated knowledge of critical controls & input/output requirements preferred• Excellent written & verbal communication skills required• Auditing experience with certification preferred• Experience with LEAN, Six Sigma & other continuous improvement methodologies required• Expert competence in one or more core validation areas preferred• Knowledge of statistical methods required• Expert in utilizing appropriate root-cause analysis tools & techniques preferred• Experience with Risk Assessment & Risk Management required• Demonstrated excellence with time management, organizational & project management skills required• Expertise in planning/organizing, checking results & revising work plan for complex problems required
Benefits
• Leading pay and annual performance bonus for all positions• Generous paid time off and 14 paid holidays• Health Insurance, Dental Insurance, Vision Insurance - effective day one• 401K contribution and match option• Paid parental and family medical leave• Free access to Novo Nordisk-marketed pharmaceutical products• Tuition Assistance• Life & Disability Insurance• Employee Referral Awards• Opportunities, resources, and mentorship for career growth
