Manager, Quality Assurance

About AskBio

Asklepios BioPharmaceutical, Inc. (AskBio) is a leading, clinical-stage gene therapy company founded in 2001 based on the work of adeno-associated virus (AAV) gene therapy visionary and pioneer, Jude Samulski, PhD. Since that time, our commitment to developing life-saving medicines that can potentially cure genetic diseases has never wavered.

At AskBio, we’ve built a foundation of therapeutic programs, AAV manufacturing and a rich portfolio of patented technology. Our therapeutic focus includes neuromuscular, central nervous system, cardiovascular and metabolic diseases with clinical trials underway for Pompe disease, Parkinson’s disease, and congestive heart failure. Our gene therapy platform includes Pro10™, an industry-leading proprietary cell line manufacturing process, and an extensive AAV capsid and promoter library.

We became a wholly-owned, independently operated, subsidiary of Bayer AG in late 2020 as a cornerstone of its newly formed Cell & Gene Therapy (CGT) platform. Our global headquarters is in Research Triangle Park, NC. Additionally, we have significant operations in Philadelphia, PA, Columbus, OH, Scotland, France, and Spain.

Our vision: Pioneering science to create transformative molecular medicines.

Our mission: Lead innovative science and drive clinical outcomes to transform people’s lives.

Our principles:

  • Advance innovative science by pushing boundaries.
  • Bring transformative therapeutics to patients in need. 
  • Provide an environment for employees to reach their fullest potential. 

Our values:

  • Be a Pioneer. We are not afraid of the impossible and to innovate to make gene therapies accessible to those in need.
  • Cultivate Collaboration. Strive to be the best teammate, actively listen, openly communicate, and embrace diverse points of view.
  • Embrace Responsibility. We are humbled by the enormity of our mission. We hold a relentless commitment to advance science and clinical outcomes for our patients, families, and caregivers.
  • Raise the Bar. Continuously drive improvements and efficiencies. Seek and provide constructive feedback. Have a bias for learning and action.
  • Act with Uncompromising Integrity. Be honest, transparent, and committed to doing what’s right in every situation. Make clear commitments and follow through.

We have an opportunity for a Manager, Quality Assurance to join the AskBio team and be part of our continued success!

Position Overview

The Manager, Quality Assurance, reporting to the Director, GMP Quality Assurance, will be responsible for assisting in the management of AskBio’s Quality Management System (QMS) and will strongly support AskBio’s Culture of Quality. This role will assure corporate compliance with applicable GMP national, international, and state regulations.  This position will be based at AskBio’s headquarters facility in RTP, NC with 15% domestic travel expected.

Responsibilities

  • Assist in the development, implementation, and integration of AskBio’s QMS and AskBio’s Culture of Quality.
  • Provide quality reviews of various records including, but not limited to Change Controls; SOPs; analytical methods, protocols, and summary reports; equipment and computer system qualification and validation plans, protocols, and summary reports; batch records; QC data; primary and secondary packaging; labels; deviations, non-conformities, Corrective Action/Preventive Action (CAPAs).
  • Develop key metrics reporting to drive continuous improvement in compliance.
  • Recruit, manage, develop, and mentor QA Specialist(s).
  • Assist in the qualification and oversight of vendors, contract manufacturers, contract laboratories, and service providers.
  • Lead and provide support for internal and external audits per AskBio procedures and applicable regulatory requirements.
  • Participate in project meetings as a quality lead and support colleagues by acting as a technical resource for quality and compliance related issues.
  • Maintain Quality Systems in support of AskBio’s QMS and GMPs, including:
    • Author SOPs, process SOP drafts and revisions, and conduct periodic SOP reviews.
    • Process change controls.
    • Support equipment and computer system qualification and validation activities and vendor management program.
    • Review of manufacturing records including, but not limited to batch records, QC data, primary and secondary packaging, labels.
    • Perform internal audits and support external audits.
    • Process deviations, non-conformities, Corrective Action/Preventive Action (CAPAs).
    • Collect and prepare Management Review Meeting data including key metrics to drive continuous improvement initiatives.
  • Support material release activities, including in-house and materials located at domestic and international CDMO facilities, to ensure cGMP compliance.
  • Communicate project status to stakeholders and escalate issues in a timely manner.

Required Education and Experience

  • Bachelor’s degree in a scientific field.
  • 5+ years of experience in pharmaceutical, biotech, or biologics GMP regulated manufacturing environment with 3+ years in Quality and/or Manufacturing.
  • Experience leading small teams including managing, developing and mentoring people.

Preferred Experience and Skills

  • Solid understanding of GMP guidelines and Quality Systems with the ability to apply GMPs in conformance to U.S. standards, and where appropriate, other regulatory authority standards.
  • Knowledge of aseptic manufacturing processes.
  • Ability to author, review, and interpret Standard Operating Procedures (SOPs).
  • Ability to identify and/or resolve quality issues/discrepancies with others in a proactive, diplomatic, flexible, and constructive manner.
  • Strong attention to detail, highly organized and the ability to multitask in a fast-paced, highly interactive environment.
  • Excellent verbal and written communication skills, and the ability to effectively collaborate with peers including scientific/technical colleagues.
  • Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).

 

Asklepios BioPharmaceutical, Inc. (AskBio) is an Equal Opportunity Employer and does not discriminate against any employee or applicant for employment because of race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status or any other protected status prohibited under Federal, State or local laws. All employment decisions are based on valid job‐related requirements. If you are a qualified individual with a disability or a disabled veteran and are unable or limited in your ability to use or access our website, you may request a reasonable accommodation to express interest in a specific opening by calling us at (919) 561-6210 or emailing us at talent@askbio.com.