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.

The successful candidate will bring deep Quality Systems expertise, a builder’s mindset, and a proven track record of strengthening compliant, audit-ready systems in sterile pharmaceutical operations. This individual will be central to ensuring inspection readiness, regulatory compliance, and a culture of continuous improvement across the site.

This role will begin as an individual contributor and site SME for Quality Systems, with the opportunity to build and lead a team as the QMS and the organization mature.

• 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 (Track Wise), 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.

• 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…