Register
Recruit Create CV
Unfortunately, this job posting is expired.
Don't worry, we can still help! Below, please find related information to help you with your job search.
Related keywords
Some similar recruitments
Quality Assurance Coordinator Jobs
Recruited by International Rescue Committee 9 months ago Address , Silver Spring, Md
Quality Assurance Manager Jobs
Recruited by Knowles Precision Devices 11 months ago Address Minden, NV, United States
Associate Manager, Quality Operations, Gigafactory Nevada
Recruited by Tesla 1 year ago Address , Sparks, 89434, Nv
Housekeeping Quality Assurance Manager - Mgm Grand
Recruited by MGM Resorts International 1 year ago Address , Las Vegas, 89109, Nv

Quality Assurance Manager – Operations And Compliance

Company

Asklepios BioPharmaceutical
Address , Research Triangle Park, Nc
Employment type FULL_TIME
Salary
Expires 2023-07-24
Posted at 11 months ago
Job Description
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:
  • Bring transformative therapeutics to patients in need.
  • Advance innovative science by pushing boundaries.
  • Provide an environment for employees to reach their fullest potential.
Our values:
  • Act with Uncompromising Integrity. Be honest, transparent, and committed to doing what’s right in every situation. Make clear commitments and follow through.
  • 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.
  • Be a Pioneer. We are not afraid of the impossible and to innovate to make gene therapies accessible to those in need.
The Quality Assurance Manager – Operations and Compliance, reporting to the Director, GMP Quality Assurance – Operations and Compliance, will be primarily responsible for the development, maintenance and optimization of the site electronic document management systems and implementation of a site data integrity program. This individual will also be responsible for assisting in the management of all other AskBio’s Quality Management Systems (QMS) and will strongly support AskBio’s Culture of Quality. This role will ensure corporate compliance with applicable GMP national, international, and state regulations. This position will be based at our headquarters facility in RTP, NC with domestic travel (less than 15% of the time) possible.
Responsibilities
  • Assist in the qualification and oversight of vendors, contract manufacturers, contract laboratories, and service providers, as needed.
  • Collect and prepare Management Review Meeting data including key metrics to drive continuous improvement initiatives.
  • Recruit, manage, develop, and mentor QA Specialist(s).
  • Communicate project status to stakeholders and escalate issues in a timely manner.
  • Support any/all other Quality Assurance related activities, as needed by area management.
  • Assist in the development, implementation, and integration of AskBio’s QMS and AskBio’s Culture of Quality.
  • Develop and support implementation of a Data integrity program, including implementation of continuous improvement initiatives.
  • Participate in project meetings as a quality lead and support colleagues by acting as a technical resource for quality and compliance related issues, as needed.
  • Process change controls.
  • Author SOPs, process SOP drafts and revisions, and conduct periodic SOP reviews.
  • 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).
  • 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.
  • 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.
    • Deviations, OOS, and Corrective Action/Preventive Action (CAPAs).
    • Collect and prepare Management Review Meeting data including key metrics to drive continuous improvement initiatives.
  • Develop, monitor, and report key metrics reporting to drive continuous improvement in compliance.
  • Support material release activities, including in-house and materials located at domestic and international CDMO facilities, to ensure cGMP compliance.
  • Perform internal audits and support external audits.
  • Provide support for internal and external audits per AskBio procedures and applicable regulatory requirements.
  • Development, implementation, and maintenance of the site GMP based electronic document management system processes. Serve as project manager to ensure proper implementation of the optimized process through SOP development/implementation, training, and managing associated change controls.
  • Deviations, OOS, and Corrective Action/Preventive Action (CAPAs).
Required Education & Experience
  • Experience leading small teams including managing, developing and mentoring people.
  • 5+ years of experience in pharmaceutical, biotech, or biologics GMP regulated manufacturing environment with 3+ years in Quality and/or Manufacturing.
  • Bachelor’s degree in a scientific field.
Preferred Experience & Skills
  • Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).
  • 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.
  • Strong attention to detail, highly organized and the ability to multitask in a fast-paced, highly interactive environment.
  • Ability to identify and/or resolve quality issues/discrepancies with others in a proactive, diplomatic, flexible, and constructive manner.
  • Ability to classify GxP related documentation correctly based on purpose and scope.
  • Strong knowledge/experience in the development, implementation, and maintenance of a document management process related to maintenance of procedures, protocols, reports, and other general GxP based documentation.
  • Ability to author, review, and interpret Standard Operating Procedures (SOPs).
  • Excellent verbal and written communication skills, and the ability to effectively collaborate with peers including scientific/technical colleagues.
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 .
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.