With extensive experience in developing biologics and bioconjugates, we offer a seamless service delivered by fully integrated teams, from early discovery to commercial manufacturing.
Forward-thinking and committed, we find the best solution and use the right technologies to design, develop and manufacture your products to ensure we get vital medicines to patients quickly and safely.
We are dedicated to quality excellence. We are driven to get better treatments to market, efficiently and responsibly by reducing timelines and delivering the highest quality products and services.
We are Abzena. More than a CDMO, we are a responsible and dedicated partner that takes care of your products from concept to patient.
The QA Training Manager reports to the Director of Quality Operation & Compliance. This role will provide leadership and execute daily responsibilities for site training activities, support document control activities, and other Quality Systems for the site. This individual will be a primary point of contact for site training activities and is the direct liaison to global ZenQMS for training administration. This role will collaborate with Quality leadership and departmental stakeholders to ensure accurate and timely delivery and execution of training to ensure regulatory, global, site, and departmental goals and requirements are maintained and met. Identifies and aids in the implementation of innovative and enhancements to Training and support document management initiatives, as required. This role requires the ability to manage multiple tasks simultaneously, work independently, and be a champion for cGMP compliance for the site.
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.
$100,000 - $150,000 a year
FLSA: Exempt
Abzena is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws. This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, and training.
We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.
