Quality Manager: Documentation and Training

myhrabc; Columbus (OH); Hybrid; USD 100,000 - 130,000; Full time

Job summary

Cencora in Columbus, OH seeks a Quality Manager: Documentation and Training to lead development and implementation of robust training programs and related policies. You will ensure alignment with cGMP and FDA requirements while managing the eQMS and onboarding initiatives.

You will partner with SMEs, drive training across departments, and provide regular updates to executive leadership. The role requires strong leadership, strategic thinking, and a focus on compliance and continuous improvement.

Qualifications

• This role requires a Bachelor's degree and 5+ years in a regulated industry (pharma or medical devices).
• 3+ years of leading teams or management experience preferred.
• Knowledge of FDA regulations and cGMP is required.
• Experience with an electronic Quality Management System (eQMS) is required.

Responsibilities

• Manage and develop onboarding methodologies, standards, programs, policies, and procedures.
• Oversee the eQMS and coordinate with functional leaders to address training needs.
• Design and implement effective training to close identified gaps.
• Evaluate training effectiveness and report status to senior management.
• Ensure compliance trainings meet cGMP/FDA/OSHA/DEA requirements.

Skills

Leadership

Training program design

Regulatory compliance

Effective communication

Project management

Organizational skills

Education

Bachelor's degree

Tools

eQMS

MS Office

Job description

Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere.

Job Details

Shift Hours: Monday- Friday 7:30AM-4:30PM/8:00AM-5:00PM

Please note, flexibility in schedule will be required based on business needs, this can include working different hours or days.

Location: This position is located onsite at our facility in Columbus, OH. There is an option of a hybrid work schedule, with 3 days in office, 2 days remote.

This role is in support of American Health Packaging, a Cencora business offering pharma packaging services in the US.

Under the general direction of the Senior Director, the Quality Manager: Documentation and Training, will be responsible for managing the development and implementation of consistent training programs and the policies and procedures of Cencora. In addition, the individual will continually assess training development needs to ensure the most current and accurate content is delivered via up-to-date methodologies and technologies. This role also serves as a liaison between subject matter experts (SMEs) and associates to direct the delivery of knowledge in a way that meets the organization's needs for effective instruction and retention.

This position is compliance critical, and responsibilities include ensuring continual and proper compliance with all division corporate and government regulatory requirements. It is the associate's responsibility to observe all safety rules. Any condition thought to be hazardous or unsafe should be reported to the management team immediately.

• Manages the Documentation & Training department including design, planning and implementation of the onboarding methodologies, standards, programs, policies, and procedures.
• Manages and administrates the electronic Quality Management System (eQMS).
• Consults with functional leaders to identify, prioritize, and facilitate any specific training needs.
• Leads, designs and implements effective training programs to close identified gaps.
• Continually evaluates and monitors effectiveness of training programs.
• Creates a training and development strategy to implement learning solutions across departments within the organization.
• Leads the New Hire training team to ensure new team members are ready to begin On-The-Job training.
• Provides reports and updates to executive management as required regarding the status of training and documentation.
• Ensures mandated compliance training programs (as they relate to cGMP/FDA, OSHA, DEA and Cencora Compliance) are current for all required team members.
• Provides guidance to all departments on training programs and delivery methodologies - (i.e., instructor-led classroom, structured hands-on On-the-Job Training (OJT), independent study, e-learning modules).
• Designs, executes and evaluates continuous improvement to Compliance Orientation Training Program.
• Provides required input during audits/inspections regarding training and documentation practices of the facility.
• Assures all associates follow cGMP and safety procedures.
• Performs related duties as assigned.

Experience and Education

Training in fields such as business administration, marketing, computer sciences or similar vocations generally obtained through completion of a four-year Bachelor's Degree program or equivalent combination of experience and education.

A minimum of 5 (five) years' experience in a regulated industry (e.g., pharmaceutical, medical device, biologics). 3 + (Three or more) years of leading teams and/or management experience is preferred.

Knowledge of FDA regulations required.

Experience with an eQMS is required.

Skills and Abilities

• Ability to lead and manage individuals.
• Ability to develop and maintain cooperative working relationships.
• Good verbal and written communication skills
• Solutions-minded mentality
• Proficient in Microsoft Office applications
• Possess strong organizational skills for prioritizing workload and responsibilities.
• Ability to handle multiple projects and a variety of tasks simultaneously.
• Must be able to work in a fast-paced environment and deliver projects and requests on time with respect to established timelines.

What Cencora offers

We provide compensation, benefits, and resources that enable a highly inclusive culture and support our team members' ability to live with purpose every day. In addition to traditional offerings like medical, dental, and vision care, we also provide a comprehensive suite of benefits that focus on the physical, emotional, financial, and social aspects of wellness. This encompasses support for working families, which may include backup dependent care, adoption assistance, infertility coverage, family building support, behavioral health sol