Supervisor, Quality Assurance Operations

Overview of Andelyn Biosciences

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.

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.

Lastly, the Supervisor will be integral in fostering a culture of Quality and Continuous Improvement while also ensuring that aseptic practices are strictly adhered to the highest standards

• Provide Quality oversight of the manufacturing facility including manufacturing operations, testing, inspection, distribution, and utilities.
• Execute Quality Systems to support CDMO manufacturing and lot release, GxP auditing, and training
• Review and audit complex documents: batch records, GMP protocols, and process and method validations
• Fully support the Product Disposition of client lots for release
• Review and approve master and executed batch records
• Support and execute elements of client audits/inspections as needed,
• 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 sponsor and regulatory audits
• 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 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 to specific measurable objectives requiring operational planning skill 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
• Frequent involvement in customer relations
• 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
• Other duties as assigned

• Must possess a relevant four-year degree OR relevant Masters OR relevant PhD, background in the life sciences, biotechnology or gene therapy industries preferred
• Experience requirements:
• Master’s degree and 3 years of quality experience

• - Bachelor’s degree and 5 years of quality experience
• 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

• 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)

As an organization, we are committed to creating an environment where everyone ACCTS.