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SalaryAsklepios 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.
About the role
This position is responsible for providing QA oversight of AskBio’s Vendor Qualification Program for GCLP, GLP, and GCP vendors. Ability to perform occasional audits of vendors, alongside subject matter experts, both at vendor’s location and virtually, as appropriate. Vendors may include, CROs managing preclinical or human clinical studies, laboratories performing routine and/or specialized assays, CROs providing imaging services, centralized assessments, etc. This role will ensure vendor qualification program assures compliance with applicable GLP, GCP, and GCLP guidelines and national, international, and local regulations. This position will report to the Associate Director, Quality Assurance (GCP/GLP).
Responsibilities:
- Maintains and manages risk-based model for qualification and quality oversight of GCP, GLP, and GCLP vendors in compliance with AskBio SOPs.
- Conduct regular vendor assessments to assess regulatory compliance, performance and identify areas for improvement.
- Assessments may be done by questionnaire and/or audit
- Identify, track status, and schedule audits and assessments of GLP/GCLP/GCP vendors;
- Manage improvements and contribute to the advancement of the GCP, GLP, and GCLP Vendor Qualification program by identifying opportunities and implementing risk-appropriate enhancements to the Vendor Qualification infrastructure.
- Along with subject matter experts, perform Vendor Audits and/or Assessments for GCP, GLP, GCLP vendors.
- Support Functional Area staff to resolve observations and quality issues arising across vendors, including but not limited to:
- Risk/impact assessment,
- CAPA development, execution, effectiveness assessment;
- Maintain and evolve models and mechanisms for ensuring awareness and application of Vendor Qualification QMS requirements
- Ensure compliance and adequacy of any GLP/GCP/GCLP Quality Agreements,
- Contribute to the development, implementation, and maintenance of SOPs.
- Assist Manager with QA support of the Clinical Operations Functional area, as requested.
- Support the coordination and management of regulatory agency inspections, parent company audits, etc.
- Participate in meetings as a quality lead, as requested.
- Other duties, as assigned by Quality Assurance Management.
- Some travel may be expected to perform audits (~20%).
About you
Requirements:
- Bachelor’s degree, in science, health care, business or other relevant field and 3+ years of relevant industry experience
- Knowledge of industry best practices and regulatory requirements (Good Clinical Laboratory Practice, Good Laboratory Practice, Good Clinical Practices)
Preferred Skills & Qualifications:
- Proven experience in vendor qualification or management, desired
- Laboratory, Clinical Research, and/or Quality Assurance; or related field, experience.
- Audit experience, desired
- Strong collaborative skills. Must be able to effectively collaborate cross-functionally with peers, scientific and technical staff; and be comfortable working in a matrixed team
- Ability to identify and/or resolve quality issues/discrepancies with others in a proactive, diplomatic, flexible, and constructive manner
- Ability to prioritize, organize, work independently, and multi-task among multiple projects and tasks simultaneously
- Analytical mindset with attention to detail
- Excellent interpersonal, verbal, and written communication skills
- Proficiency in MS Word, Excel, PowerPoint, and other applications
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 sending us an email at
careers@askbio.com
. Agencies: Please do not contact any employee at AskBio about this requisition. Any resume submitted by a recruitment agency to any employee at AskBio, through any medium, will be deemed the sole property of AskBio unless the agency was engaged by AskBio Talent Acquisition team to recruit for that position. All agencies must have a prior executed service agreement with AskBio prior to any search engagement. If a candidate who was submitted outside of the AskBio agency process is hired by AskBio, no fee or payment of any kind will be paid to the agency.
