Sr. Mgr., Quality Management Systems

About the role

For our client, we are seeking a Sr. Mgr., Quality Management Systems to join the team of a leader in the Pharmaceuticals & Biotech space. This role will lead the continued development and optimization of quality risk management and quality system processes within a regulated GxP environment. The position will partner cross-functionally to strengthen risk-based decision-making, support compliant documentation practices, and help drive a culture of quality across the organization. The ideal candidate will bring deep experience in quality assurance, global quality standards, and computer system validation, along with the leadership skills needed to influence stakeholders and improve operational performance. Location: Remote - US based candidates only, no visa sponsorship available

Responsibilities

• Lead the creation and enhancement of the Quality Risk Management program and related tools
• Facilitate risk assessments across functions using methodologies such as FMEA and hazard analysis
• Define risk management processes, including ownership, mitigation, and monitoring of risks
• Communicate QRM trends and metrics and integrate risk management principles within company procedures
• Serve as a backup for document control and GxP training activities, ensuring compliance and record maintenance
• Oversee quality management systems, revise procedures, and track performance indicators
• Collaborate across departments to foster a quality culture and guide risk-based decisions

Qualifications

• Bachelor's degree in a scientific or technical discipline, or equivalent experience
• At least 7 years of Quality Assurance or related experience in the pharmaceutical or biotechnology sector
• Proven track record in building and improving a Quality Risk Management program in a GxP environment
• In-depth understanding of GxP regulations and global quality standards
• Strong leadership skills to drive cross-functional initiatives and communicate risk-based guidance effectively
• Experience with Veeva Vault Quality applications, including document control and GxP training processes
• Familiarity with Computer System Validation, particularly risk-based validation approaches

Pay

$147,700 – $176,500 annually

Benefits

• Market-leading compensation package with performance bonuses
• 401(k) plan with employer match and employee stock purchase program
• 100% employer-paid healthcare premiums for employees and dependents
• Flexible paid time off and generous company-paid holidays for work-life balance
• Comprehensive mental health support and family-forming benefits
• Investment in employee development through training programs and career pathing opportunities