Associate Director of Quality Compliance

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.

He/She will be responsible for Supplier Quality Management (Vendor Management), Internal/External Audits and Inspections, and elements of Regulatory Affairs.

• Oversee and host Health Authority inspections including, but not limited to, FDA, EMA, and other applicable health agencies.
• Leads a team of supplier auditors in support of Supplier Quality Management and Internal/External audits.
• Demonstrated people leader experience (e.g. Workforce Planning, talent development, Budget adherence experience, promoting an inclusive and collaborative culture of trust and respect).
• Manage lifecycle of Supplier Quality Management (onboarding, qualification, monitoring, requalification, and disqualification).
• Support and/or conduct audits of providers of raw materials, product contact consumables, contract manufacturing or testing, software, warehouse / distribution.
• Manage all aspects of the audit and inspection lifecycle including scheduling, planning, issuing agendas, executing, issuing reports, evaluating responses, requesting clarification, issuing CA/PA, and closing.
• Champion of continuous improvement for all programs responsible for.
• Represent the Quality function in by developing the program and supporting the selection process for new/preferred suppliers
• Ensure that the audit agenda is risk-based and has the appropriate internal and/or external subject matter experts as part of the audit team.
• Work directly with Andelyn cross-functional departments to gather key information and feedback prior to conducting vendor audits in order to ensure effectiveness.
• Identify compliance risks and escalate issues to appropriate levels of management for resolution.
• Drive consistency with audit report observation writing, classification, status, and overall risk
• Travel (Domestic and International) may be required up to 5 - 10%.
• Supports Quality Management Review (QMR).
• Defines, implements, and manages the inspection readiness program.
• Manages Quality Metrics related to audits and supplier quality.
• Reviews and approves GMP documentation (SOPs, batch records, protocols, technical reports, test methods, specifications, Master Validation Plans, Validation Protocols/Reports, Quality Assurance Manual, and summary reports to support GMP manufacturing).
• Interprets Regulations and Guidance documents and implements them in the company.
• Other duties as assigned.

Regulatory Intelligence:

• Effectively communicate regulatory trends, insights and implications for Andelyn to senior leadership with presentations and written reports
• Respond to queries from internal stakeholders to support inspection readiness, external audits, regulatory submissions and staff training
• Maintain online platforms (e.g., SharePoint) to provide intelligence related to products and testing associated with client programs
• Own the Drug Master File and ensure accuracy at all times
• Design and author GMP RI newsletters to staff with timely and actionable knowledge to support the distilling information across multiple departments
• Other responsibilities as required to meet business needs

• Must possess a Bachelor’s, Master or Ph.D. degree in Life Sciences
• Background in the life sciences, biotechnology, or gene therapy is highly desirable.
• Must have experience with Audits and Inspections at a high capacity.
• At least 8 – 10 years of experience in cGMP relative to biological products and cell cultures.
• Broad knowledge of the field with demonstrated leadership skills.
• Prior supervisory experience is required.
• 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.
• 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.