QA Training Manager

Abzena•San Diego, CA

About The Position

The Manager of Training reports to the Director of Quality Operation & Compliance and provides leadership for the site’s Document Control staff and training activities and initiatives. The role works with Quality leadership and departmental stakeholders to ensure timely and accurate document and training delivery and compliance with regulatory, global, site, and departmental requirements. It also identifies and helps implement improvements to Document Management and Training initiatives. The position requires the ability to manage multiple tasks, work independently, and champion cGMP compliance. The role leads the Document Control and Training teams and functions, manages the document management and training program, and directly performs or assists with daily work in these areas. It maintains the global Document Control system and related electronic management systems, supports QMS and CSV qualification activities, provides quality metrics, conducts internal audits, and supports customer communications and audits related to document control. As a manager, this position plans and evaluates department policies, processes, priorities, and performance goals; develops and enforces systems and productivity standards; supports staff development; reviews performance metrics; and collaborates with senior management and other department managers.

Requirements

Bachelor of Science or Bachelor of Arts degree, preferably in science.
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 successfully collaborate and work with a multidisciplinary team.
Familiarity with Microsoft Office applications.
High ethical and moral standards and professional conduct with internal and external business associates.

Responsibilities

Lead the Document Control and Training teams and functions.
Manage the document management and training program.
Partner with Quality leadership on short-term and long-term Quality initiatives.
Collaborate with Quality leadership and departmental stakeholders to ensure accurate and timely delivery of documents and training and meet applicable requirements.
Lead and perform daily tasks in Document Control and Training, both independently 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 quality 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.
Plan and evaluate department 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 collaborative relationships and communicate effectively with senior management and other department managers.
Regularly review performance metrics and adjust strategies as necessary.