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Head of Quality

3 months ago

Columbus, Ohio, United States Andelyn Biosciences Full time
Overview of Andelyn Biosciences

**Biopharmaceutical Company Overview**

**Andelyn Biosciences** is a leading **Contract Development and Manufacturing Organization (CDMO)** specializing in advancing innovative gene therapies from inception to commercialization.
Located in **Columbus, OH**, the company has expanded to three facilities with over 250,000 combined square feet of space.

The company operates from three primary centers: **Andelyn Corporate Center (ACC)** for cGMP manufacturing, **Andelyn Development Center (ADC)** for preclinical non-cGMP activities, and **Andelyn Plasmid Center (APC)** for research and cGMP plasmid production.

Our Values are deeply rooted in our history.

The origin of the name **Andelyn** stems from two pivotal gene therapy **patients** involved in groundbreaking Phase I clinical trials at Nationwide Children's Hospital. Andrew was the first to undergo U.S. investigational gene therapy for Duchenne muscular dystrophy in 2006, while Evelyn received experimental gene therapy for spinal muscular atrophy in 2015. This fusion of their names, **Andelyn**, honors all the families who have fearlessly participated in the pioneering research that has enabled today's gene therapies. Through our journey, we have significantly accelerated the **development** and **manufacturing** of cutting-edge therapies to provide more treatments to a wider range of patients.
We are **Innovating Solutions** that Transform **Hope** into **Reality** through our **ACCTS ions**:
**- ACCOUNTABLE** in our actions.
**- CURIOUS** to discover.
**- COMPASSIONATE** in our thinking.
**- TRUSTWORTHY** in our **communications**.
**- SUPPORTIVE** of one another.
Employees are entrusted with carrying out vital functions under the philosophy of our **ACCTS ions**.

**Role Overview**
The Head of **Quality** plays a pivotal role in leading the **Quality** and **Regulatory** organization and is an integral member of the corporate leadership team. This position is responsible for providing both strategic and operational guidance to establish, enhance, and uphold the **quality** systems, policies, standards, and procedures. The Head of **Quality** ensures adherence to current **US FDA**, **EMA**, and related **ICH** guidelines. Further responsibilities include overseeing all **quality** assurance activities concerning internal and external manufacturing, contract release and stability testing, and raw material suppliers. Additionally, the Head of **Quality** is accountable for ensuring adequate staffing in **Quality Assurance (QA)**, **Quality Control (QC)**, **Contamination Control**, and **Regulatory Affairs** through talent acquisition, team development, and empowerment. This role fosters a culture of **quality** within the organization, acting as a mentor and guide to all levels of the **Quality** Organization and corporate leadership.

**Key Responsibilities Include:**
**-** Establishing quality strategies for ensuring cGMP compliance with regulatory agencies' regulations.
**-** Leading **quality** planning and execution processes.
**-** Developing comprehensive plans to achieve **quality** and business objectives.
**-** Implementing a quality policies strategy aligned with current regulatory expectations for rare diseases.
**-** Ensuring that **quality** systems and processes are suitable for product development and application stages.
**-** Overseeing **manufacturing**, testing, release, and distribution of gene therapy products to meet regulatory requirements.
**-** Establishing and managing **Quality Management Review (QMR) process** to ensure continued compliance with CGMP standards.
**-** Directly engaging with regulatory authorities to represent the company on compliance and **quality** matters.
**Expectations and Qualifications**
Candidates must hold a relevant four-year degree, Master's, or PhD in addition to a background in life sciences, biotechnology, or gene therapy industries. Critical skills include **business acumen**, **advanced leadership abilities**, and profound **communication** and **organization** skills. Proficiency in Microsoft Office and the capability to manage multiple projects effectively is essential. An independent yet collaborative work approach within a diverse setting is required along with a client-focused mindset and experience handling confidential data.

**Working at Andelyn**
Joining Andelyn means contributing to the **development** and **manufacturing** of life-saving therapies. It offers the opportunity to be part of an evolving organization's foundation alongside experts with extensive experience in gene therapy. Employees can expect competitive compensation, various benefits like medical, dental, and vision plans, generous Paid Time Off, Paid Holidays, Life Insurance, 401(k) Match, Parental Leave, Tuition Reimbursement, Flexible Work Options, and more. Andelyn Biosciences embraces diversity and proudly champions equal employment opportunities without discrimination based on various factors.

**Company Note:** Please note that the original job reference ID has been omitted for security and privacy reasons.