Quality Assurance Supervisor

Overview of Andelyn Biosciences

Andelyn Biosciences is a biopharmaceutical Contract Development and Manufacturing Organization (CDMO) focused on advancing novel gene therapies from concept to commercialization. Located in the heart of Columbus, OH, the company has expanded to three buildings with more than 250,000 combined square feet of space. The Andelyn Corporate Center (ACC) is dedicated to cGMP manufacturing, the Andelyn Development Center (ADC) for preclinical non-cGMP activities, and the Andelyn Plasmid Center (APC) for research and cGMP plasmid production.

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 Pioneering Solutions that Turn 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 Operations Supervisor role is responsible for supporting internal Quality Assurance functions focused on GMP manufacturing operations and associated Quality systems, including change controls and internal process verification. The supervisor will work collaboratively with the training team to ensure manufacturing colleagues are operating in compliance with Quality systems.

Execute Quality systems to support CDMO manufacturing and lot release, GxP auditing, and training.

Provides quality support for external and internal AAV and Plasmid manufacturing and clinical product distribution.

Review and audit complex documents: batch records, GMP protocols, and process and method validations.

Fully support the Product Disposition of client AAV and Plasmid lots for release

Review and approve master and executed batch records.

Observe manufacturing activities to support the implementation of best practices and improvements.

Administer, review, follow-up, and approve internal/external Deviations, Change Records, and Corrective and Preventive Actions (CAPAs).

Manage the DMS by authoring, reviewing, and approving Policies, SOPs, and WINs as needed.

Communicate quality metrics, client production tracking and metrics, and quality improvement initiatives to senior leadership.

Provide oversight and input to Trend Review Reporting and Lifecycle Review activities to identify and address process shifts and trends.

Act as QA SME during client and regulatory audits.

Schedule QA-on-the-floor responsibilities for the QA Operations team in support of manufacturing activities

Ensures that documentation is maintained in accordance with internal procedures and regulatory requirements.

Supports and maintains an environment that fosters communication and teamwork within Quality Assurance and related departments.

Exercise discretion, judgment, and personal responsibility.

Demonstrate a high level of integrity.

Maintain a positive attitude.

Attention to detail in all job functions.

Performs in accordance with established policies, procedures, and techniques and requires training common experience, or working knowledge related to the tasks performed.

Anticipating problems and removing obstacles to enable staff to perform tasks as assigned.

Work on specific measurable objectives requiring operational planning skills with little direct supervision.

Cultivate a diverse and collaborative team environment. Utilizes clear and concise communication to deliver high productivity and contribution to the success of department goals.

Developing and enforcing procedures and controls

Approval of procedures established by junior staff.

Frequent involvement in audits

Frequent involvement in customer relations

Significant responsibility for inspection outcomes

Responsible for hiring, development, and related personnel processes.

Mentoring and professional development of staff.

Exercise crucial people skills.

Ability to manage and influence people in direct and lateral support structure.

Have significant latitude for making decisions for their operational or functional unit.

Drives timelines and development through broad influence.

Minimal interaction with legal services.

Other duties as assigned.

What you bring to the team.

Must possess a relevant four-year degree OR relevant Masters OR relevant PhD, background in the life sciences, biotechnology or gene therapy industries preferred.

Working knowledge of team function within the organization.

First-level leadership. Coordinates and leads daily team activities. May spend a portion of time performing the work of those they supervise.

Prior supervisory experience is preferred.

Excellent detailed knowledge of cGMP, GLP, FDA guidelines

Excellent communication, organization, and project management skills with the ability to manage multiple projects efficiently and adjust as priorities change.

Must be highly skilled in Microsoft Office (PowerPoint, Excel, Word) including data interpretation and reporting.

Ability to work independently as well as collaboratively in a diverse and inclusive work environment.

Must possess a client-focused mindset in daily tasks.

Must possess prior experience handling confidential information and the ability to maintain confidentiality.

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 on 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.

Permanent