The role:The Associate Director, Quality Systems reports to the Vice President of Quality and is responsible for the day-to-day management, administration, and continued development of the company's quality management system, including electronic QMS administration, document and records management, GxP training, QMS metrics and trending, and related quality systems processes. The role will collaborate closely with functional groups, including Legal, IT, HR, and Corporate, to maintain a lean, practical, and inspection-ready management system that supports both GxP requirements and applicable company policies and procedures as the organization progresses toward commercialization.
Key responsibilities:- Manage the day-to-day operation and administration of the electronic QMS, including users, roles, permissions, workflows, document and record types, metadata, and related system configuration.
- Manage document and records processes, including document lifecycle, classification, retention, archival status, retrieval, and appropriate controls for GxP and company records.
- Partner with functional groups to maintain applicable company policies, procedures, and GxP documents within the document management system.
- Manage onboarding and offboarding activities related to QMS access, training assignments, and other quality system requirements.
- Manage the GxP training program, including role-based training matrices and curricula, training assignments, system administration, follow-up of required training, and evaluation of training effectiveness, and qualification or competency requirements.
- Serve as a subject matter resource for core QMS processes, including document management, change control, deviations, CAPA, quality risk management, training, and records management.
- Develop and maintain QMS metrics and trending; compile and report departmental Quality metrics; support management review and assessment of QMS effectiveness.
- Apply ISO 9001 principles to support integration and effective management of applicable company-wide policies and processes within the quality management system.
- Identify and implement opportunities to simplify and improve quality system processes while maintaining appropriate compliance and control.
- Support process improvement, standardization, workflow optimization, continuous improvement, and operational excellence, with increasing responsibility in these areas as the company progresses toward commercialization.
- Support inspection and audit readiness by ensuring quality system documentation, records, and training information are complete, current, organized, and readily retrievable.
- Support computerized system validation activities and, depending on organizational needs and team capabilities, may assume primary responsibility for the computerized system validation program.
- Flex across Quality responsibilities as organizational needs evolve.
Required experience & skills:- Bachelor's degree in life science, quality, engineering, or related discipline.
- Minimum of 10 years of progressive pharmaceutical or biotechnology quality experience, with substantial direct experience managing quality management systems.
- Demonstrated hands-on experience with electronic QMS administration, document and records management, GxP training, change control, deviations, CAPA, and other core QMS processes.
- Demonstrated knowledge and practical application of ISO 9001 principles and quality management system requirements.
- In-depth understanding of controlled documents and GxP record types, metadata, classification, retention, lifecycle management, and retrieval.
- Demonstrated experience developing and maintaining role-based training matrices and administering GxP training programs.
- Strong working knowledge of GxP principles, with sufficient GMP experience to understand and manage documentation and records across pharmaceutical development.
- Strong attention to detail and demonstrated ability to establish and maintain logical, consistent document, record, metadata, and training structures.
- Excellent organizational, problem-solving, prioritization, and time-management skills
- Ability to independently manage multiple quality systems activities and work effectively across functional teams.
- Strong written and verbal communication skills with a collaborative, team-oriented approach
- Ability to thrive in a fast-paced, dynamic environment and remain comfortable with change and ambiguity.
- Flexible, proactive, and hands-on mindset with a roll-up-your-sleeves, can-do attitude
Preferred experience & skills:- Experience working in a small, growing, or startup pharmaceutical or biotechnology organization
- Experience developing or expanding a quality management system in a growing organization
- Experience with QMS metrics, trending, management review, process improvement, continuous improvement, and operational excellence
- Lean Six Sigma Green Belt or Black Belt certification
- Experience supporting regulatory inspections and GxP audits
- Experience with computerized system validation and oversight of GxP computerized systems
- Experience supporting late-stage development and transition toward commercial operations
Base Salary Range: $170k - $200k
This role is also eligible for a competitive total rewards package, which may include an annual bonus, equity, and a comprehensive benefits offering.
