Quality Manager: Documentation and Training

Cencora•Columbus, OH
•Hybrid

About The Position

The Quality Manager: Documentation and Training leads the Documentation & Training department for American Health Packaging, a Cencora business providing pharmaceutical packaging services in the United States. Under the general direction of the Senior Director, this role manages the development and implementation of consistent training programs, policies, procedures, onboarding methods, and standards. The manager assesses training needs and develops current, accurate learning content and delivery methods, working as a liaison between subject matter experts and associates to support effective instruction and retention. This compliance-critical role manages and administers the electronic Quality Management System (eQMS), supports compliance with corporate and government requirements, and ensures mandated training related to cGMP/FDA, OSHA, DEA, and Cencora Compliance is current for required team members. The manager provides guidance on training methodologies, leads new-hire training, evaluates program effectiveness, reports status to executive management, and supplies input on training and documentation practices during audits and inspections. The position is onsite in Columbus, Ohio, with an option for a hybrid schedule of three days in the office and two days remote. The typical schedule is Monday through Friday, 7:30 a.m.–4:30 p.m. or 8:00 a.m.–5:00 p.m.; flexibility for different hours or days may be needed based on business requirements.

Requirements

  • Training in business administration, marketing, computer sciences, or a similar vocation, generally obtained through a four-year bachelor's degree program or an equivalent combination of experience and education.
  • At least five years of experience in a regulated industry, such as pharmaceutical, medical device, or biologics.
  • Knowledge of FDA regulations.
  • Experience with an electronic Quality Management System (eQMS).
  • Ability to lead and manage individuals.
  • Ability to develop and maintain cooperative working relationships.
  • Good verbal and written communication skills.
  • Solutions-minded mentality.
  • Proficiency in Microsoft Office applications.
  • Strong organizational skills, including the ability to prioritize workload and responsibilities.
  • Ability to handle multiple projects and varied tasks simultaneously.
  • Ability to work in a fast-paced environment and deliver projects and requests on time.

Nice To Haves

  • Three or more years of team leadership and/or management experience.

Responsibilities

  • Manage the Documentation & Training department, including the design, planning, and implementation of onboarding methodologies, standards, programs, policies, and procedures.
  • Manage and administer the electronic Quality Management System (eQMS).
  • Consult with functional leaders to identify, prioritize, and facilitate specific training needs.
  • Lead, design, and implement training programs to address identified gaps, and continually evaluate and monitor their effectiveness.
  • Create a training and development strategy to implement learning solutions across departments.
  • Lead the New Hire training team to prepare new team members to begin on-the-job training.
  • Provide executive management with reports and updates on the status of training and documentation.
  • Ensure mandated compliance training relating to cGMP/FDA, OSHA, DEA, and Cencora Compliance is current for required team members.
  • Guide departments on training programs and delivery methods, including instructor-led classroom sessions, structured hands-on on-the-job training, independent study, and e-learning modules.
  • Design, execute, and evaluate continuous improvements to the Compliance Orientation Training Program.
  • Provide required input during audits and inspections regarding facility training and documentation practices.
  • Ensure associates follow cGMP and safety procedures, observe safety rules, and report hazardous or unsafe conditions to management.
  • Perform related duties as assigned.

Benefits

  • Medical, dental, and vision care.
  • Wellness resources addressing physical, emotional, financial, and social well-being.
  • Support for working families, which may include backup dependent care, adoption assistance, infertility coverage, family-building support, behavioral health solutions, paid parental leave, and paid caregiver leave.
  • Training programs and professional development resources.
  • Mentorship programs.
  • Employee resource groups.
  • Volunteer activities.
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