Quality Assurance Compliance Senior Specialist

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 Compliance Senior Specialist is an individual contributor role and provides compliance and quality assurance support to the Internal and Regulatory audits activities, as well as the Supplier Management program. This position will report to the QA Compliance Manager and will work closely with the Andelyn Corporate Center (ACC) staff. To ensure compliance with defined Quality System procedures and regulatory standards. In addition, it will be responsible for conducting regulatory gap assessments and information analysis.

Perform supplier/service provider qualifications in accordance with company and regulatory requirements.

Ensure each supplier/service provider qualification state is current and track supplier qualification status using TrackWise.

Implement Quality Technical Agreements and track to ensure timely reviews are performed following applicable SOPs.

Supports the company's quality audit program, including internal audits, and audits conducted by clients and by the FDA and third-party international regulators.

Apply working knowledge of applicable regulations and standards, instruct associates on the quality system regulations, and maintain awareness of evolving industry and regulatory trends/regulations.

Perform compliance vendor audits to ensure vendors and service providers continue to work in compliance with company and federal standards.

Escalate supplier quality issues to Site Quality leadership as necessary.

Provide Quality guidance on GMP regulatory requirements (including 21CFR Parts 210, 211, 312, 314, 820, Part 11, and EudraLex Volume 4 and applicable annexes, and ICH Guidelines).

Support the development and maintenance of quality assurance and compliance policies and standard operating procedures, meeting domestic and international regulations.

Establish and monitor key performance indicators (KPIs) for identified suppliers.

Ensure support in the resolution of supplier-related quality or service issues including mitigation plans/support.

Operate within the electronic Quality Management System (i.e., TrackWise) to document supplier change notifications, change assessments, CAPAs, deviation investigations, Supplier corrective actions, etc.

Additional tasks within QA, as assigned.

Maintain compliance with applicable regulatory requirements for cellular and gene therapy products.

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

Solving, correcting, preventing problems, and performing tasks as assigned by leadership, as well as assigning tasks to junior staff.

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

Documentation of all activities performed according to SOPs.

Make decisions based on established procedures.

Availability for travel required.

Responsibility for completing inspections as assigned.

Mentoring and professional development of junior staff at Andelyn on Audit and Supplier Quality topics.

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.

Five years relevant (w/4 YR deg) or two years (w/Masters).

Experience in biologics or gene therapy preferred.

Proficient knowledge of cGMP regulations and guidelines including but not limited to U.S. Code of Federal Regulations 21 CFR Part 11 and Part 210 & 211, European Directives, ICH guidelines, and cGMP regulations.

Demonstrable experience in working with external suppliers.

Experience with Audits (authorities, customers).

Effectively manage relationships with all internal and external clients.

Ability to properly manage the audit schedule for a large number of suppliers.

Experience in commercial and clinical GMP production.

Experience with aseptic manufacturing operations, preferred Strong negotiation and communications skills, solid organizational skills.

Fluency in English.

Work with minimum supervision, be a team player, be self-motivated, and demonstrate initiative leadership, and good interpersonal skills.

Exercise discretion, judgment, and personal responsibility.

Demonstrate a high level of integrity.

Maintain a positive attitude.

Attention to detail in all job functions.

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.

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