Senior Analyst supporting Compliance Center of Excellence regulatory reporting for healthcare. Managing recurring regulatory reports and collaborating across business areas to ensure timely submission to agencies.
About the role
- Sr. Manager leading Quality Assurance and Supplier Compliance teams in biotech. Ensuring compliance and overseeing documentation and supplier qualification processes in a hybrid setup.
Responsibilities
- responsible for leading and managing the day-to-day activities of the Northpointe site Quality Assurance Product Release and Supplier Compliance teams
- oversee the team supporting raw material, biologic cell banks, and bulk drug substance release and supplier compliance processes
- ensure quality unit procedures align with standard operating procedures, good manufacturing practices, and regulatory compliance requirements
- provides team leadership and hands-on execution for quality review and approval of GMP documentation
- responsible for PTx’s Supplier Qualification Program
- maintains current and accurate supplier and site subcontractor Quality Technical Agreements
- develops and manages metrics to monitor and improve processes
- prepares for inspection readiness for audits and inspections
- resolves “stuck” issues by timely escalation to Leadership and cross-functional teams
- builds, develops, inspires, motivates, and leads a diverse, professional team
- establishes individual goals and objectives in alignment with department goals and priorities
- ensures compliance to safety and quality regulations and holds Team accountable
Requirements
- 10+ years of progressively responsible experience in the Quality function within the Pharmaceutical/Biotech industries
- significant experience supporting key functional areas including Manufacturing, QC, and Supplier Compliance
- 8+ years in People Leadership or project Lead roles
- Possesses a deep background in Quality Assurance and Regulatory Compliance within the biotech or pharmaceutical industry
- Demonstrates proficiency in fermentation and purification biologic product disposition, supplier qualification, supplier change notification, and supplier risk management
- Comprehensive knowledge of FDA regulations and experience with US regulatory agency audits and inspections in the biopharmaceutical industry
- Expert level experience in document control, inspection readiness and regulatory audit inspection support
- Strong relationship management and interpersonal skills
- Strong critical thinking, analytical, and problem-solving skills
- Strong organizational and prioritization skills
- Excellent soft skills including a bias towards action and adaptability
- Strong written and oral English communication skills
Benefits
- medical, dental, vision, FSA/DCA, HRA, disability, and life insurance coverage
- casual workplace program
- Hybrid or Remote workplace program
- pre-IPO options
- annual cash bonuses
- 401k matching
- free parking or Seattle-area ORCA pass
- tuition assistance
- rewards for achievement and contribution
- gym subsidy
- wellness participation programs
- generous vacation, sick, and holiday paid time off program
- paid shutdown between the Christmas and New Year’s holidays
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