QA Document Control and Training Supervisor/Manager

Andelyn Biosciences is a biopharmaceutical Contract Development and Manufacturing Organization (CDMO) that specializes in advancing novel gene therapies from concept to commercialization.  Located in Columbus, OH, the company operates out of the Andelyn Corporate Center (ACC) for clinical and commercial cGMP manufacturing of viral vectors and plasmids and the Andelyn Development Center (ADC) for preclinical non-cGMP activities.

 Our Values are founded in our origin story.

The name “Andelyn” is a hybrid of two gene therapy patients who participated in pivotal Phase I clinical trials at Nationwide Children’s Hospital. Andrew received the first U.S. investigational gene therapy for Duchenne muscular dystrophy in 2006. Evelyn received experimental gene therapy for spinal muscular atrophy in 2015. “Andelyn” combines their names to represent all the families who have courageously participated in the research that makes today’s gene therapies possible. 

Through this journey, we have been able to accelerate the development and manufacturing of innovative therapies to bring more treatments to more patients. We are Turning Hope Into Reality through our ACCTSions.

ACCOUNTABLE in our actions.

CURIOUS to discover.

COMPASSIONATE in our thinking.         

TRUSTWORTHY in our communications.

SUPPORTIVE of one another.

Employees are expected to perform the following essential functions under the framework of our ACCTSions.

What you will do.

The QA Document Control and Training Supervisor/Manager serves the business by developing, facilitating, and supervising the document control and training programs. They assess the needs of a business, implement development and training plans, and facilitate a wide variety of training programs that enhance the technical knowledge of the workforce. In addition, this role serves as the administrator and Subject Matter Expert (SME) for the Document Management and Learning Management Systems at Andelyn.Provide strategic plan and expertise for the development and implementation of the site Sterility Assurance Program.

• Administer and optimize the Document Management System (DMS) and Learning Management System (LMS), ensuring data integrity and system functionality
• Identify and mitigate gaps in training content and materials that need updating to generate higher productivity and safety among staff
• Research and implement new training techniques and document control practices
• Identify future training needs and create a curriculum to facilitate that training.
• Supports quality management review (QMR). Track QA Training and Document Control KPIs and report results to team and management.
• Develop and implement scalable document control processes to support company growth. This includes the implementation of Document Change Requests.
• Conduct orientation programs and arrange on-the-job training for new hires, as needed
• Coordinates with all departments for timely closure of audit-related CAPAs and Change Controls.
• Works closely with department SMEs to effectively design and align training programs that build core general process expertise
• Author, review and approve GMP documentation (i.e., Policies, SOPs, Work Instructions, Investigations, CAPAs, etc.)
• Ensure proper version control, archival, retrieval, and distribution of documents. Establish and maintain document control procedures aligned with GxP requirements
• Act as QA Document Control and Training SME during sponsor and regulatory audits
• Works towards specific measurable objectives requiring operational planning skills with little direct
• supervision.
• Cultivate a collaborative team environment and provide support for the DMS and LMS
• Solves, corrects, and performs tasks as assigned by leadership
• Hire, mentor, and manage training and document control staff. Develop and monitor goals for direct reports.
• Other duties as assigned.

What you bring to the team

• Must possess relevant four-year degree OR relevant Masters, background in the life sciences, biotechnology, or gene therapy industries preferred, background in the life sciences, biotechnology, or gene therapy is highly desirable.
• Six+ years relevant (w/4 YR deg)
• Experience with electronic document management systems (e.g., ComplianceWire, TrackWise)
• Broad knowledge of the field with demonstrated leadership skills. Considered highly skilled and proficient in discipline.
• Demonstrated ability to manage document lifecycles and ensure audit readiness

• Excellent communication (oral and written), organizational, project management, and multitasking skills.
• Must be highly skilled in Microsoft Office (PowerPoint, Excel, Word) including data interpretation and reporting.
• Must possess a client-focused mindset in daily tasks.
• Strong knowledge of GxP requirements and regulatory standards (FDA, EMA, and ICH)
• Excellent decision-making and problem-solving skills
• Good collaboration and teamwork skills

What you can expect when working at Andelyn.

• The pride of contributing to the development and manufacturing of life-saving therapies
• The invaluable experience of being a part of building the foundation of a new organization.
• The opportunity to work alongside experts who have over 10 years in the gene therapy field.
• Competitive compensation
• Eligible day one for medical, dental, and vision insurance plans with basic vision at 100% company-paid
• 160 hours of Paid Time Off annually
• 11 Company Paid Holidays plus 2 floating holidays annually.
• Company Paid Life Insurance
• 401(k) Match
• Company Paid short and long-term disability.
• 4 weeks of Paid Parental Leave for birth and adoption
• Adoption Assistance
• Tuition Reimbursement and Student Loan Repayment Assistance
• Company Paid LinkedIn Learning access.
• Employee Assistance Programs
• Flexible work options (role specific)

Andelyn Biosciences embraces diversity and is an equal opportunity employer and does not discriminate based on race, religion, national origin, gender, gender identity, genetic information, sexual orientation, protected veteran status, disability, age, or another legally protected status. As an organization, we are committed to creating an environment where everyone ACCTS.