QA Training Manager
About The Position
The QA Training Manager reports to the Director of Quality Operation & Compliance and leads the site’s Document Control staff, training activities, and related initiatives. The role collaborates with Quality leadership and departmental stakeholders to deliver accurate and timely documents and training while meeting regulatory, global, site, and departmental requirements. It also identifies and helps implement improvements to Document Management and Training initiatives. The position requires managing multiple tasks, working independently, and championing cGMP compliance. The role manages the document management and training programs, oversees Document Control and Training teams, and performs or assists with daily operational tasks. It facilitates controlled-document review, processing, maintenance, and archival; supports electronic and paper GMP logbooks; maintains workflow status; and executes electronic management systems related to document control. The manager evaluates processes for continuous improvement, provides quality metrics, updates tracking tools, supports QMS and CSV qualification activities, conducts internal audits, and supports customer communications and audits. As a people manager, the role sets and evaluates department policies, processes, priorities, and performance goals; develops staff; establishes systems and productivity standards; builds collaborative relationships with senior management and other departments; reviews performance metrics; and adjusts strategy as needed.
Requirements
- Bachelor of Science or Bachelor of Arts degree; science preferred.
- At least 7 years of Quality Assurance experience in a GMP-oriented or regulated environment.
- 3 to 5 years of direct people leadership experience.
- Ability to perform under pressure, work independently, multitask, and stay organized.
- Excellent written and verbal communication skills.
- Experience with regulatory or health authority inspections, client audits, and internal audits.
- Knowledge of GMP regulations, good documentation practices, cGMP, 21 CFR, EU GMP, and other applicable regulations, standards, and guidance.
- Ability to collaborate successfully with multidisciplinary teams.
- Familiarity with Microsoft Office applications.
- High ethical and moral standards.
- Professional conduct with internal and external business associates consistent with company policies and practices.
Responsibilities
- Lead the Document Control and Training teams and functions.
- Manage the document management and training programs.
- Partner with Quality leadership on short- and long-term Quality initiatives.
- Collaborate with Quality leadership and departmental stakeholders to ensure timely, accurate document and training delivery and compliance with applicable requirements.
- Lead and perform daily Document Control and Training tasks, individually and as part of a team.
- Organize, maintain, and archive controlled documents.
- Write, review, revise, approve, and process SOPs, batch records, protocols, and equivalent documents through the Document Control system.
- Issue document, part, lot, and investigation numbers.
- Issue and review electronic and paper-based GMP logbooks.
- Maintain Document Control workflow status to support on-time completion.
- Evaluate document management and training processes for continuous improvement.
- Provide Document Control and Training quality metrics and update Quality Systems tracking tools as required.
- Assist with QMS and CSV qualification activities as required.
- Conduct internal audits of Document Control and Training processes.
- Support customer communications and customer audit processes related to Document Control.
- Collaborate with site personnel to promote consistent execution of quality processes.
- Execute and maintain electronic management systems related to Document Control.
- Manage department staff, policies, processes, priorities, and performance goals.
- Motivate direct reports through positive feedback and skills development.
- Develop, coordinate, and enforce systems, policies, procedures, and productivity standards.
- Build productive relationships with senior management and other department managers through clear communication.
- Review performance metrics regularly and adjust strategy as needed.
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What This Job Offers
Job Type
Full-time
Career Level
Manager
