Senior Manager, Quality Systems

About the role

The Sr. Manager, Quality Systems serves as the subject matter expert (SME) and owner of the site Quality Management System (QMS) within a sterile cGMP manufacturing environment. This role is responsible for designing, establishing, maintaining, and continuously improving the QMS framework — including Document Control and Data Integrity, Change Control, Deviations and CAPA, Training, Internal Audit, and Management Review — in alignment with FDA cGMP (21 CFR 210/211/11), Section 503B, and other applicable standards.

Responsibilities

• Lead the design, implementation, and continuous improvement of the site QMS, ensuring compliance with cGMP, 503B, and applicable global standards and best practices.
• Implement and administer the site electronic QMS (TrackWise), in conjunction with global process owners, including data migration, training, and development of site processes/procedures.
• Develop, monitor, and report quality metrics and KPIs to site and senior leadership; lead Management Review and drive data-driven decision-making.
• Own the document control system for all GMP documentation (SOPs, work instructions, forms, policies), ensuring records are current, reviewed, approved, controlled, and distributed.
• Interface with global stakeholders and process owners to review and integrate business-unit and global policies at the site.
• Maintain a secure, compliant repository and ensure document retention and archival align with regulatory and company requirements.
• Champion data integrity (ALCOA+) and compliance with 21 CFR Part 11 across paper and electronic records.
• Own the Deviation and CAPA programs, coaching/mentoring owners, approving records, and ensuring timely investigation, sound root cause analysis, and effective closure.
• Own the Change Control program, driving effective planning, risk-based guidance across cross-functional teams, SME assessments, tracking implementation, and on-time closure.
• Establishing governance processes for relevant Quality System elements, to enhance oversight and drive accountability.
• Develop, implement, and maintain the site training/competency program and Learning Management System (LMS), ensuring GMP and role-based training matrix compliance for all personnel.
• Conduct training assessments, develop training materials, and coordinate onboarding, recurring, specialized, and trend-driven retraining; maintain accurate, audit-ready training records.
• Establish and lead the internal audit program and maintain a state of continuous inspection readiness.
• Support FDA, state board, and global audits; coordinate and author responses to observations (e.g., Form 483) and drive corrective actions to completion.
• Own investigations, change controls, assessments, projects, and other records for areas of responsibility.
• Partner with Manufacturing, Quality, R&D, Engineering, Regulatory, and site leadership to resolve quality issues and foster a culture of compliance and accountability.
• Maintain current expertise in regulations and guidance (FDA, ICH, etc.), regulatory intelligence & industry trends, and implementing changes as needed.

Requirements

• Bachelor’s degree in Life Sciences, Engineering, Quality, or a related field (or equivalent experience).
• 7+ years of progressive experience in Quality Assurance / Quality Systems within an FDA-regulated environment; sterile injectable cGMP or 503B experience strongly preferred.
• Demonstrated ownership of multiple QMS elements (document control, change control, deviations, CAPA, training, audit).
• Experience building and/or remediating systems in a high-growth environment preferred.
• Proven ability to lead teams, drive continuous improvement, and develop strategies that result in measurable quality enhancements.
• Hands-on experience in paper systems and implementing and administering an eQMS (e.g. TrackWise).
• Deep, working knowledge of industry regulations and guidance (FDA, ISO, ICH, EMA).
• Experience supporting regulatory (i.e. FDA) inspections and audits in front or back room with successful outcomes.
• Strong background in root cause analysis, risk management, and continuous improvement methodologies.
• Experience leading, mentoring, or developing others, with the ability to build and lead a team as the role scope grows.
• Experience interfacing with Senior Leadership, inclusive of effective delivery of metrics, remediation plans, etc.
• Excellent technical writing, communication, and cross-functional collaboration skills.
• Demonstrated ability to independently prioritize, problem-solve, and deliver results in a fast-paced environment, with minimal supervision and high accountability.

Qualifications

• Competitive salary & equity compensation for full-time roles.
• Unlimited PTO, company holidays, and quarterly mental health days.
• Comprehensive health benefits including medical, dental & vision, and parental leave.
• Employee Stock Purchase Program (ESPP).
• 401k benefits with employer matching contribution.
• Offsite team retreats.

Benefits

• Comprehensive health benefits including medical, dental & vision, and parental leave.
• Employee Stock Purchase Program (ESPP).
• 401k benefits with employer matching contribution.
• Offsite team retreats.