Senior Manager, Quality Systems

Job Title: QA Compliance / QMS Manager

Department: Quality Assurance

Position Summary

The QA Compliance / QMS Manager is responsible for supporting and coordinating site Quality Management System (QMS) activities to ensure compliance with applicable GMP requirements, company procedures, client expectations, and regulatory standards.

This role will provide oversight and coordination for quality events, audits, inspection readiness, continuous improvement activities, and other quality initiatives. The position requires strong cross-functional collaboration, proactive follow-up, sound quality judgment, and the ability to manage multiple priorities in a dynamic GMP environment.

The incumbent is expected to support evolving site and business needs and may be assigned additional QA responsibilities, projects, or initiatives by QA leadership as appropriate.

Key Responsibilities

• Coordinate and support site Quality Event activities, including deviations, CAPAs, change controls, and other applicable quality records.
• Monitor open Quality Events, due dates, aging, risks, and closure status; proactively follow up with owners and stakeholders to support timely and compliant completion.
• Identify potential delays, bottlenecks, or compliance risks and work with cross-functional teams to establish appropriate action plans, escalation, and resolution.
• Support assignment and coordination of Quality Approvers, subject matter experts, and other required reviewers for Quality Events.
• Facilitate effective communication among QA, Manufacturing, QC, Engineering, Validation, and other functional groups to support Quality Event investigations and closure.
• Coordinate internal, client, and regulatory audit or inspection readiness activities, including preparation, scheduling, document and evidence collection, SME coordination, response tracking, and follow-up actions.
• Support mock inspections, internal audits, periodic quality reviews, management review activities, and other site compliance initiatives.
• Track audit and inspection observations, commitments, and responses to ensure timely and appropriate closure.
• Support site continuous improvement activities, including process improvement projects, PSP/Kaizen initiatives, quality metrics, trending, and identification of recurring quality issues.
• Develop, maintain, and improve trackers, dashboards, or other tools necessary to provide visibility of open Quality Events, audit actions, compliance risks, and other key quality activities.
• Support timely review and coordination of Quality Events associated with site programs, clinical or commercial manufacturing activities, PPQ campaigns, and other business-critical projects.
• Coordinate with global or external SMEs, as appropriate, to facilitate review, comment resolution, investigation support, and timely decision-making.
• Support preparation and review of quality-related information for client requests, questionnaires, due diligence activities, RFPs, audits, and other external interactions as needed.
• Support development, implementation, and continuous improvement of site QMS processes, procedures, governance mechanisms, and compliance practices.
• Participate in quality metrics review and trending to identify risks, recurring issues, improvement opportunities, and areas requiring management attention.
• Ensure assigned activities are completed in accordance with applicable GMP regulations, company policies, SOPs, and established timelines.
• Maintain required training and remain current on applicable GMP regulations, quality systems, site procedures, and assigned functional responsibilities.
• Serve as a QA representative on cross-functional teams, projects, quality initiatives, or site programs as assigned.
• Provide support to other QA functions and site quality activities based on operational priorities, regulatory requirements, client commitments, resource needs, or business priorities.
• Perform additional duties, projects, and responsibilities as assigned by QA leadership to support site quality, compliance, operational, and business objectives.
  
  
  
  

Qualifications

• Bachelor’s degree in Life Sciences, Engineering, Pharmacy, Chemistry, Biotechnology, or a related discipline; advanced degree preferred.
• Relevant experience in Quality Assurance, Quality Systems, Compliance, Manufacturing, QC, or a related GMP-regulated environment.
• Working knowledge of GMP regulations and Quality Management Systems.
• Experience with deviations, CAPAs, change controls, investigations, audits, inspections, or related quality processes preferred.
• Experience working in pharmaceutical, biotechnology, biologics, CDMO, or other regulated manufacturing environments preferred.
• Familiarity with electronic quality management systems such as TrackWise, MasterControl, Veeva, or similar systems is preferred.
  
  
  
  

Knowledge, Skills, And Abilities

• Strong knowledge of GMP principles and quality systems.
• Ability to manage multiple priorities, timelines, and cross-functional activities in a fast-paced environment.
• Strong organizational, follow-up, and project coordination skills.
• Ability to identify risks, escalate issues appropriately, and drive actions toward timely resolution.
• Strong written and verbal communication skills.
• Ability to work effectively with employees and leaders across multiple departments and organizational levels.
• Strong problem-solving, critical-thinking, and quality decision-making skills.
• Ability to work independently while maintaining appropriate communication with management and stakeholders.
• Demonstrated accountability, ownership, and responsiveness.
• Ability to adapt to changing priorities, evolving business needs, and new quality responsibilities.
• Ability to support urgent, time-sensitive, or business-critical quality activities when required.
  
  
  
  

Performance Expectations

The incumbent is expected to demonstrate proactive ownership of assigned responsibilities, maintain visibility of risks and timelines, communicate potential issues early, and actively facilitate resolution rather than relying solely on passive follow-up.

Performance will be evaluated based on overall quality, compliance, timeliness, effectiveness, collaboration, and contribution to site and organizational objectives. Specific goals, priorities, and performance metrics may be established or adjusted periodically based on site needs, regulatory commitments, client requirements, project priorities, and business objectives.

Other Responsibilities

This job description is intended to describe the general nature and level of work performed by the individual in this position. It is not intended to be an exhaustive list of all duties, responsibilities, or qualifications.

Responsibilities may evolve based on changes in site operations, regulatory expectations, client commitments, organizational structure, project requirements, or business priorities. The employee may be assigned additional duties, projects, or responsibilities that are reasonably related to Quality Assurance, compliance, site operations, or business needs.

The anticipated salary for this position $90,000 - $150,000

Job description does not intend to list all the duties and responsibilities assigned to this position. Employee holding this position would be required to perform other job-related duties/responsibilities based on their expertise and company business needs.

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.