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 Manager of Training reports to the Director of Quality Operation & Compliance. This role will provide leadership and execute daily responsibilities of the Document Control staff and training activities and initiatives for the site. This role will collaborate with Quality leadership and departmental stakeholders to ensure accurate and timely delivery of documents and 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 Document Management and Training initiatives. 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 Document Control and Training teams and functions.
- Manage the document management and training program.
- Strategically partner with Quality leadership to facilitate short-term and long-term Quality initiatives.
- Collaborate with Quality leadership and departmental stakeholders to ensure accurate and timely delivery of documents and 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 in the Document Control and Training areas.
- Operate in both a team and individual setting.
- Facilitate the review, processing, and maintenance of the global Document Control system through:
- Organization, maintenance, and archival of controlled documents.
- Writing, reviewing/revising, approving, and processing Standard Operating Procedure (SOP), Batch Record, Protocol, and equivalent documents through the Document Control system.
- Issuance of document, part, lot, and investigation numbers.
- Issuance and review of electronic and paper based GMP logbooks.
- Maintain the status of Document Control workflows to drive on time completion.
- Evaluate document management and training quality processes for continuous improvement.
- Provide Document Control and Training Quality metric as required.
- Update Quality Systems tracking tools as required.
- Assist in the QMS and CSV qualification activities as required.
- Conduct internal audits of the document control and training processes.
- Provide customer communication and customer audit processes related to document control.
- Collaborates with site personnel to drive consistency in quality process execution.
- Execute and maintain Electronic Management Systems as it relates to document control.
Manager Responsibilities
- Accomplishes department objectives by managing staff.
- Plans and evaluates department policies, processes, priorities, and performance goals.
- Motivates direct reports by providing positive feedback and skills development.
- Develops, coordinates, and enforces systems, policies, procedures, and productivity standards.
- Acts as a liaison with senior level management and other department managers by developing productive, collaborative relationships and utilizing clear and effective communication.
- Regularly review performance metrics.
- Make strategy adjustments as necessary.
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.
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.