Manager Quality Assurance - Investigations & CAPA - Andelyn Biosciences, Inc

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 Quality Assurance Manager, Investigations & CAPA role is responsible for ensuring that all deviations and complaints are investigated in compliance with Good Manufacturing Practices (cGMP) regulations, policies, and procedures. This position reports to the QA, Senior Director and will work closely with Andelyn Biosciences staff.

• Lead and support investigations throughout the lifecycle of the product.
• Manage staff of investigators on assessment of criticality, determination of affected processes, root cause analysis, and assignment of Corrective & Preventative Action (CAPA).
• Responsible for ensuring CAPAs are appropriate, are implemented as planned, and have the intended effectiveness.
• Lead cross-functional meetings to discuss findings of investigations and obtain resolution/commitments.
• Perform data analysis and trending of deviation and complaint data to identify improvement opportunities and secure resources to drive continuous improvement across the organization.
• Lead discussions with sponsors to communicate the status of the investigation, resolve issues, and recommend actions.
• Accountable for working with problems associated with a wide variety of quality issues that could range from errors in production, incomplete batch records, component reconciliation, poor documentation practices, etc.
• Author/revise Standard Operating Procedures (SOP) and supporting Work Instructions related to deviations and investigations.
• Coach and train staff on the investigation process and root cause analysis.
• Act as QA SME during sponsor and regulatory audits
• Build upon and maintain the Andelyn investigation process.
• 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 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
• Approval of procedures established by junior staff
• Has budgetary responsibility
• Moderate travel required
• 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 relevant four-year degree OR relevant Masters OR relevant PhD, background in the life sciences, biotechnology or gene therapy industries preferred
• Five years of experience, the majority in QA
• Working knowledge of team function within the organization.
• Coordinates and leads daily team activities.  May spend a portion of time performing the work of those they supervise
• Prior supervisory experience required
• 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
• Experience with Trackwise is preferred.
• 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
• Excellent detailed knowledge of cGMP, GLP, FDA guidelines

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.