Senior Manager, Training and Documentation
Senior Manager, Training and Documentation
The Quality Assurance department ensures that the site operates at a high level of compliance and ensures quality decisions are being made in accordance with Regulatory, corporate and site standards.
This position manages the training and document control functions at the site.
- Select, develop, and motivate qualified staff to effectively carry out department functions and provide for the continuity of managerial and specialized skills.
- Provide career development and guidance to direct reports. Identify training requirements/needs and job related qualifications.
- Provide leadership, guidance, and direction to staff consistent with cGMP and company corporate quality governance.
- Coach and mentor staff in all aspect of their job performance and career development including training, feedback, rewards and disciplinary action.
- Develop work plans, assign tasks, and supervise team(s).
- Ensure staff has appropriate knowledge of department processes and procedures.
- Establish, maintain and report applicable department or organizational metrics which drive accountability.
- Accountable for project completions and achievement of compliance goals relative to deviations, change controls, CAPA and effectiveness reviews.
- Represent department in Project Team meetings.
- Interact with project teams and cross-functional groups.
- Address and/or escalate site compliance problems and issues to senior department management.
- Lead and facilitate meetings/workshops.
- Participate in the integration of new computer systems and processes
- Responsible for keeping department in audit ready condition at all times.
- Create and maintain the site training plan.
- Design, development, source, and delivery of site training program content, instructional tools, and hands on exercises, including computer-based training.
- Create and Maintain training history for site.
- Set the direction for the preparation and means of delivery for regular training.
- Develop criteria for evaluating effectiveness of training activities. Ensure that training effectiveness assessments are timely and visible to the site.
- Develop and maintain procedures that govern the training and documentation functions.
- Ensure documentation programs and training procedures are current with industry standards.
- Work with the site management to evaluate training needs, and participate in the development and delivery of training materials. Lead the development of tests, participant materials and visual aids as required.
- Oversee the delivery of new hire training and identify needs/solutions for ongoing training
- Manage course evaluations and other training effectiveness tools (instructor feedback, in class evaluations, exams, etc.).
- Manage, maintain, and continuously improve the sites electronic document management system.
- In partnership with functional areas, develop training materials, and knowledge assessments, for area SOPs.
- Develop, maintain, and continuously improve site training program, including conducting effectiveness checks to ensure program applicability.
- Other duties as required.
An ongoing commitment to conducting our global business according to the highest legal and ethical standards, and to continually pursue excellence in the development and delivery of all of our products and services. This includes:
- Respecting the laws and operating within the applicable regulations of the places in which we conduct business, as well as our own Company policies and procedures.
- Being honest and treating people with respect and courtesy.
- Constantly striving to make Vericel a great place to work, and a company respected for the quality of its people and products.
- Acting as role models for our fellow employees by acting responsibly, fairly, and honestly in our dealings and exercising sound judgment in performing our jobs.
- Leaders motivate, inspire, build, and retain highly effective manufacturing teams while managing for high performance and developing others.
- They are versatile learners and courageous decision makers.
Leading the Business:
- Leaders are effective operating in an evolving, complex and dynamic environment, providing clear direction and instruction to direct reports, and continuously looking internally and externally for best practices and areas for improvement.
Delivering to Customers:
- Leaders understand patient and customer needs and build relationships as required to meet manufacturing goals while continuously improving operations by setting high standards for the team so they may perform to a level of excellence.
- Bachelor's degree or equivalent and 10+ years of training experience in a pharmaceutical, medical device, or biotech environment.
- Previous supervisory/management experience.
- Excellent verbal and written communication skills.
- Highly versed in regulatory expectations, training and assessment techniques, and key site performance indicators in the continuous management and improvement of the site training function.
All applicants will receive consideration for employment without regard to their race, color, religion, sex, national origin, sexual orientation, gender identity, or protected veteran status and will receive consideration for employment and will not be discriminated against on the basis of disability. Vericel Corporation is an Equal Opportunity/Affirmative Action Employer.
Vericel Corporation is VEVRAA federal contractor and desires priority referrals of protected veterans for job openings at all locations within the state.