Manager, Quality Assurance Compliance

About the role

This position is responsible for managing the compliance, audit, training and operations team for the internal fill finish site. This role offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

Responsibilities

• Lead and develop the QA compliance team: set work plans and objectives, prioritize and assign tasks, coach performance, and manage hiring and separations while aligning deliverables with company goals
• Partner with Managers and Directors to communicate compliance status, audit readiness, and training initiatives, and provide concise, actionable project reporting
• Oversee the lifecycle of quality records (Notices of Event, Change Controls, CAPAs): track, report, and drive timely closure
• Drive audit readiness and execution: align QA practices with requirements, run the audit-ready-365 program, plan and track coaching, and support internal and regulatory audits, including coordinating requests for the internal fill-finish team
• Promote cross-site continuous improvement by collaboratively identifying gaps and sharing best practices
• Shape governance by influencing local and global policies, procedures, and business processes to align with industry standards and best practices
• Stay current on industry trends and regulatory updates and translate insights into changes and improvements

Requirements

• BS/BA in Life Sciences or related field; or equivalent combination of education and experience
• Associate Manager Quality Compliance: 6+ years of relevant experience
• Manager Quality Compliance: 7+ years of relevant experience
• Sr. Manager Quality Compliance: 8+ years of relevant experience

Qualifications

• BS/BA in Life Sciences or related field; or equivalent combination of education and experience
• Associate Manager Quality Compliance: 6+ years of relevant experience
• Manager Quality Compliance: 7+ years of relevant experience
• Sr. Manager Quality Compliance: 8+ years of relevant experience

Skills

• Strong leadership and management skills
• Excellent communication and interpersonal skills
• Proven ability to manage multiple projects simultaneously
• Knowledge of drug product manufacturing and/or fill finish
• Experience with quality assurance and compliance
• Ability to work independently and as part of a team

Benefits

• Annual bonuses or other incentive plans
• Equity awards
• Pension or retirement benefits
• 401(k) company match
• Health and wellness programs
• Fitness centers
• Insurance benefits (e.g. medical, dental, vision, life and disability)
• Paid time off
• Family support benefits

Pay

$92,200.00 - $176,000.00 annually

Schedule

Monday-Friday, 8am-4:30pm