- Set up site training program (including Onboarding program: Quality, Safety, Documentation, etc.), work with departments to establish their training programs, including interface with SOP generation/revision processes
- Manages and grows the QA Training team responsible for administration of the cGMP
- Training program to include curricula organization and deployment, oversight of organizational training status in both local and enterprise learning management systems (LMS) and providing real-time training consultation to cross-functional stakeholders at an aseptic cell culture manufacturing facility.
- Collaborates closely with all department management at the AIRM location to determine training needs, establish training curriculums and assignments based upon work functions, and schedule training sessions.
- Partner with functional areas to conduct monitoring of training compliance status, efficiency checks, and trend results.
- Responsible for ensuring training on documentation and training related processes and procedures are performed according to defined expectations.
- Oversees the QA Training function. Ensures adequate systems are in place to achieve personnel training and qualification compliance with GMP quality expectations.
- Supplies regular metrics to management with relevant compliance insights, highlights and engages in continuous improvement opportunities.
- Provides coaching, mentoring, professional development, and performance management to junior Quality Assurance staff as appropriate.
- BS degree in Engineering, Chemistry, Biological Sciences or equivalent with 8+ years or MS with 6+ years related experience in bio-pharma industry, and 2+ years of managerial experience in a cGMP compliance environment.
- Demonstrated experience with developing or delivering training to colleagues and/or managing a training program and LMS.
- Fluency in GMP training, document administration, and data integrity principles.
- Working knowledge of predicate regulations and industry consensus standards, including 21CFR §11, §210, §211, §1271; Eudralex Volume IV (including ATMPs), ICH Q9, Q10, etc.
- Experienced in identifying, proposing, and managing quality system improvement initiatives and projects.
- Advanced proficiency in MS Word, Excel, and PowerPoint.
-
Program Manager
1 week ago
U.S. Army Acquisition Support Center Fort Detrick, United States**Duties**: · - Serve as Assistant Program Manager responsible for managing new systems through advanced development, production and fielding. · - Analyze the impact that contemplated budget revisions and proposed adjustments may have upon projects and take positive action to min ...
-
Program Manager
1 week ago
Sekon Reston, United States**SeK**ON** is looking for a **Program Manager - Call Center** to lead our talented and innovative team supporting a global federal telehealth program. · With over 25 years of experience, **SeK**ON** specializes in providing large-scale health IT programs in support of federal go ...
-
Program Manager
10 hours ago
Axle Rockville, United States**Axle** is seeking a **_Program Manager_** to join our vibrant team at the National Institutes of Health (NIH) supporting the located in **Rockville, MD.** · **Benefits We Offer**: · - 100% Medical, Dental & Vision Coverage for Employees · - Paid Time Off and Paid Holidays · - 4 ...
-
IT Program Manager
2 days ago
BAE Systems Herndon, United StatesThis is a fast paced, challenging, and career rewarding experience to recruit and develop provide top talent and solutions on one of the most complex and high-profile programs within the government. · ABC · **Required Education, Experience, & Skills** · The IT Program Manager wil ...
-
Program Manager
10 hours ago
Advanced Bioscience Laboratories Rockville, United States**Job Summary**: · **Responsibilities**: · - Perform gap analysis, regulatory requirements, market evaluation and economic feasibility of projects. · - Manage outsourcing and in-house projects for preclinical biologics/vaccine development projects that may include the following: ...
-
Program Manager
6 days ago
Dewberry Fairfax, United States**Job Description**: · Dewberry is currently seeking a P**rogram Manager - Geospatial Solutions and Analytics** for our **Fairfax, VA** office. · Dewberry's Geospatial and Technology Services (GTS) creates geospatial and analytical solutions for real-world engineering, environmen ...
-
Program Manager
1 week ago
Department of Defense Frederick, MD, United StatesDuties · • Serve as Assistant Program Manager responsible for managing new systems through advanced development, production and fielding. · • Analyze the impact that contemplated budget revisions and proposed adjustments may have upon projects and take positive action to minimize ...
-
Program Manager
1 week ago
Providencia Group Ashburn, United StatesTITLE: PROGRAM MANAGER · LOCATION: ASHBURN, VA - HYBRID · About Us · The Providencia Group is led by a purpose: to address global challenges and make an impact that matters through delivering transformative solutions. This purpose defines who we are and extends to relationships w ...
-
IT Program Manager
4 days ago
BAE Systems Herndon, United StatesBAE Systems, a top-ten prime contractor to the U.S. Department of Defense, enables the U.S. government to transform data into intelligence and provides engineering, integration and sustainment support for critical military platforms and systems. Intelligence & Security provides s ...
-
Program Manager
1 week ago
THE GENEVA FOUNDATION Rockville, United States**Geneva Employees Make An Impact** · As a leader in military medical research, at Geneva, our professionals develop critical solutions - and build rewarding careers. Our team of more than 400 employees across the world joins forces with some of the world's leading researchers an ...
-
Program Manager
1 week ago
Fairwinds Technologies, L Frederick, United StatesProgram Manager · Fairwinds Technologies is a leader in Command, Control, Computers, Communications, Cyber, Intelligence, Surveillance, and Reconnaissance (C5ISR) networks and systems globally. Fairwinds is looking for a Program Manager to handle the day-to-day activities on a n ...
-
Program Manager
1 week ago
Piper Companies Frederick, United StatesPiper Health & Sciences · is seeking a · Program Manager · to oversee project deliverables for the design and renovation of a large laboratory space, from initial stages through operational readiness. This is a hybrid role, which requires on-site work 3 days per week in the gr ...
-
Program Manager
2 weeks ago
Fairwinds Technologies, L Frederick, United StatesProgram Manager · Fairwinds Technologies is a leader in Command, Control, Computers, Communications, Cyber, Intelligence, Surveillance, and Reconnaissance (C5ISR) networks and systems globally. Fairwinds is looking for a Program Manager to handle the day-to-day activities on a n ...
-
Program Manager
2 weeks ago
Frederick Health Frederick, United StatesEnsures all services are delivered in accordance with the mission of the Frederick County Health Care Coalition (FCHCC). Develops, implements, supports and promotes healthier communities strategies defined by FCHCC utilizing creative communication, c Program Manager, Healthcare, ...
-
Program Manager
5 days ago
Frederick Health Frederick, United StatesJob Summary · The Healthcare Coalition Program Manager ensures all services are delivered in accordance with the mission of the Coalition for a Healthier Frederick County (CHFC). · This position develops, implements, supports and promotes healthier community strategies defined b ...
-
Program Manager
1 week ago
Frederick Health Frederick, United StatesJob Summary · The Healthcare Coalition Program Manager ensures all services are delivered in accordance with the mission of the Coalition for a Healthier Frederick County (CHFC). · This position develops, implements, supports and promotes healthier community strategies defined ...
-
Program Management Manager
1 week ago
SAIC Reston, United StatesJob ID: · **Location**:RESTON, VA, US · **Date Posted**: · **Category**:Program Management · **Subcategory**:Program Mgmt · **Schedule**:Full-time · **Shift**:Day Job · **Travel**:Yes, 10 % of the Time · **Minimum Clearance Required**:None · **Clearance Level Must Be Able to Ob ...
-
Program Manager
14 hours ago
United States Army Futures Command Frederick, United StatesSummary · This is a Direct Hire Authority (DHA) solicitation utilizing the DHA for to recruit and appoint qualified candidates to positions in the competitive service. · About the Position: USAMMDA develops new drugs, vaccines, and medical support devices that enhance readiness, ...
-
Program Manager
4 days ago
U.S. Army Acquisition Support Center Fort Detrick, United States Full timeServe as Assistant Program Manager responsible for managing new systems through advanced development, production and fielding. · Analyze the impact that contemplated budget revisions and proposed adjustments may have upon projects and take positive action to minimize adverse effe ...
-
Program Manager Ii
6 days ago
Montgomery County Government Rockville, United States**Program Manager II** · **_Newcomers Initiative_** · Montgomery County is located adjacent to Washington, DC and with over one million residents, is the most populous County in the State of Maryland. The County is also the most diverse County in the State and ranks among the top ...
Training Program Manager, QA - Frederick, United States - Cartesian Therapeutics
Description
Job Description
Job DescriptionSummaryThe Training Program Manager, QA reporting to the Senior Director, QA primary role will be to manage and build a training program for the Company. This person will be highly organized and enjoy teaching others and possess and demonstrate a customer service approach and perspective.
Principal Duties/Responsibilities:
Qualifications:
Work Environment:
The position requires hands-on work setting up and operating equipment in R&D and manufacturing environments. An employee in this position works in an environment in which safety, environmental and health concerns may demand constant attention. Strict adherence to Cartesian's policies, rules and regulations is required. While performing the duties of this job, the employee handles hazardous chemicals in the laboratory. The employee will be required to wear all appropriate safety equipment including but not limited to eye protection, gloves, shoes, and lab coat. Position may require extended periods of standing.
