Quality Assurance Compliance Senior Specialist

2 weeks ago

Columbus, Ohio, United States Andelyn Biosciences Full time
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 Columbus, OH, the company has expanded to three buildings with more than 250,000 combined square feet of space. They have distinct areas for different activities: the Andelyn Corporate Center (ACC) for 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 Core Values

The name 'Andelyn' is derived from two gene therapy pioneers who took part in crucial Phase I clinical trials at Nationwide Children's Hospital. This fusion of 'Andrew' and 'Evelyn' symbolizes the countless families who have bravely contributed to the groundbreaking research enabling today's gene therapies.

Our mission is to expedite the development and production of cutting-edge treatments to reach more patients. We are Innovators turning Hope into Reality through our set of guiding principles, referred to as ACCTS:

  • ACCOUNTABLE in our actions.
  • CURIOUS to explore.
  • COMPASSIONATE in our approach.
  • TRUSTWORTHY in our communication.
  • SUPPORTIVE of each other.
Job Description

Responsibilities:

  • Conduct supplier/service provider qualifications according to company and regulatory criteria.
  • Ensure current status of supplier qualifications via TrackWise.
  • Establish and oversee Quality Technical Agreements in alignment with SOPs.
  • Participate in quality audit programs including internal and regulatory audits.
  • Provide guidance on GMP regulatory requirements.
  • Monitor supplier performance through key performance indicators (KPIs).
  • Resolve supplier-related quality issues and develop mitigation plans.
  • Maintain Quality Management System documentation.
  • Lead and support team initiatives and promote collaboration.
  • Facilitate inspections and mentor junior staff members.
  • Perform other assigned quality assurance tasks.

Requirements:

  • Bachelor's degree, Master's degree, or PhD in relevant field.
  • 5 years of experience with Bachelor's degree or 2 years with a Master's degree.
  • Knowledge of cGMP regulations and guidelines.
  • Experience in biologics or gene therapy is advantageous.
  • Proficiency in Audits and supplier relationship management.
  • Strong communication and negotiation skills.
  • Ability to work independently and as part of a team.
Perks of Joining Andelyn
  • Contribution to life-saving therapies.
  • Building the foundation of a new organization.
  • Working with gene therapy veterans.
  • Competitive compensation and benefits package.
  • Paid Time Off and holidays.
  • Life insurance, 401(k) match, and more.
  • Professional development opportunities.
  • Support for diverse workforce and inclusive environment.

Andelyn Biosciences promotes diversity and is an equal opportunity employer, fostering an inclusive workplace for all employees.

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