QA Training Manager

Responsibilities

• Directly responsible for leadership of the Training initiatives and functions.
• Manage the site training program.
• Strategically partner with Quality leadership to facilitate short-term and long-term training and other Quality initiatives as assigned.
• Collaborate with Quality leadership and departmental stakeholders to ensure accurate and timely delivery of training to ensure regulatory, global, site, and departmental goals and requirements are maintained and met.
• Directly lead as well as perform, execute, and assist in the execution of daily tasks of Training.
• Operate in both a team and individual setting.
• Facilitate the review, processing, and maintenance of the global Training system through:
• Writing, reviewing/revising, approving, and processing Standard Operating Procedure (SOP).
• Evaluate training processes for continuous improvement.
• Provide Training Quality metrics as required.
• Update tracking tools as required.
• Assist in the QMS and CSV qualification activities as required.
• Participate in and conduct internal audits of training processes.
• Provide customer communication and customer audit processes related to document control.
• Collaborates with site personnel to drive compliance.
• Represent Quality Compliance at Tier 2 meetings for training. Alternate Tier 2 representative for document control.
• Support client and regulatory audits at the site.
• Primary liaison and site SME on global ZenQMS training initiatives.
• Develop and implement site ZenQMS user Work Instructions to provide use instructional tools, as needed.
• Aid in new hire onboarding relating to GDP and GMP training.
• Adhere to Quality standards as set by regulations, Abzena policy, procedure and mission.
• Other duties as assigned

Manager Responsibilities

• BA/BA degree, preferably in science.
• Preferred a minimum of seven (7) years’ experience in a GMP-oriented environment within Quality Assurance.
• Ability to work well under pressure, independently, capability multi-task, is well organized, and have excellent communication skills.
• Knowledge of GMP regulations, good documentation practices, cGMP, 21 CFR, and other applicable regulations, standards, and guidance.
• A demonstrated ability to successfully interface and provide guidance to a multi-disciplined team.
• A demonstrated ability to present and train others.
• A strong working knowledge of Microsoft Office applications and Smartsheet’s.
• Detailed oriented with strong analytical, written, and verbal communication skills.
• Operates to the highest ethical and moral standards.
• Exhibits professional behavior with both internal and external business associates that reflect positively on the company and is consistent with the company’s policy and practices.

Qualifications

• BS/BA degree, preferably in science.
• Minimum Seven (7) years of experience in Quality Assurance within a GMP oriented/regulated environment. Three (3) to Five (5) years of direct people leadership experience.
• Demonstrated ability to perform under pressure, work independently, multi-task, and organizational skills.
• Excellent written and verbal communication skills.
• Experience in regulatory/health authority inspections, client and internal audits.
• Knowledge of GMP regulations, good documentation practices, cGMP, 21CFR, EU GMP, and other applicable regulations, standards, and guidance.
• Demonstrated ability to successfully interface and collaborate with a multi-discipline team.
• Must be familiar with Microsoft Office applications.
• Operates to the highest ethical and moral standards.
• Exhibits professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company’s policies and practices.

Physical Requirements

• Ability to stand for 2-4 hours at a time and site for 2-3 hours at a time.
• Frequently lift and or move objects up to 30 pounds.
• Visual attributes include the ability to correct near and far-sighted challenges, determine color, and have a sense of visual depth and peripheral acuity.