Quality Assurance Manager – Product Quality

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.
• Provide an environment for employees to reach their fullest potential.
• Advance innovative science by pushing boundaries.

Our values:

• Raise the Bar. Continuously drive improvements and efficiencies. Seek and provide constructive feedback. Have a bias for learning and action.
• 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.
• Act with Uncompromising Integrity. Be honest, transparent, and committed to doing what’s right in every situation. Make clear commitments and follow through.
• 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 – Product Quality, reporting to the Director, GMP Quality – Product Quality, will be responsible for supplier quality initiatives including SOP and Specification development, Quality Agreements, Risk Assessments, supplier change management, regulatory filing authoring and review, and vendor/supplier/CDMO management. The ability to effectively lead, collaborate, influence, and coordinate amongst suppliers and team members within Quality Assurance, Manufacturing and Supply Chain, Analytical Development, Process Development, Regulatory Affairs, and CMC Leadership is critical to this role.
This role will strongly support AskBio’s clinical pipeline and will be a lead in establishing and modeling a 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.
Job Responsibilities

• Review and approve Investigations / OOS / Change Controls.
• Partner with and oversee third-party contract manufacturers and contract laboratories.
• Support material release activities, including in-house and materials located at domestic and international CDMO facilities, to ensure cGMP compliance.
• Ensure that products are manufactured and tested in compliance with regulatory and GMP guidelines.
• Ensure Quality Agreement(s) are maintained and managed per procedural requirements.
• Lead quality issue escalation activities, as required.
• Work closely with GLP/GCP quality counterparts to ensure a comprehensive compliance program for all aspects of pharmaceutical quality.
• Provide QA representation on clinical CMC teams; collaborate with Manufacturing, Analytical Development, Quality, Process Development, Project Management, Supply Chain, QC, and MSAT teams to functionally lead and drive execution of the defined program strategies.
• Supporting the development, implementation, and continuous improvement of AskBio products, processes, and quality systems. Support the execution of ambitious goals and business strategies to ensure the progression of clinical programs within AskBio and subsidiaries.
• Support and guide QC principles, systems, and GMP activities.
• Support Quality Management interactions with the FDA, EMA, AEMPS, and other regulatory authorities worldwide.
• Process Change Controls, SOPs revisions, and conduct periodic SOP reviews.
• Provide QA oversight of Supply Chain activities, CMO initiatives, and Technology Transfers.
• Communicate lot disposition pending issues to management.
• Monitor supplier quality and work directly with Supply Chain and suppliers/CMOs to improve performance.
• Compile and review batch-related documents into a final product lot disposition package.
• Review manufacturing records including, but not limited to batch records, QC data, primary and secondary packaging, and labels.
• Provide support for internal and external audits per AskBio procedures and applicable regulatory requirements.
• Assist in the development, implementation, and integration of AskBio’s QMS and AskBio’s Culture of Quality.
• Ensure that the quality systems of external partners comply with regulatory and commercial expectations, escalating concerns to management.
• Support staff by acting as a technical resource for Quality and compliance related issues based on knowledge of regulations, guidelines and relevant SOP's.
• Communicate project status to stakeholders and escalate issues in a timely manner.
• Develop, monitor, and report key metrics reporting to drive continuous improvement in compliance.
• Recruit, manage, develop, and mentor QA Specialist(s).
• Perform other duties as required.
• Support any/all other Quality Assurance related activities, as needed by area management.
• Mentor AskBio personnel to support technical, scientific, development, and career growth.
• Support vendor audits as needed, including appropriate planning, auditing, development of reports, and close-out.
• Support onsite Person In Plant support at critical vendors/CDMOs, infrequent international travel may be required.

Required Education & Experience

• Bachelor’s degree in a scientific field.
• 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.

Preferred Experience & Skills

• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).
• Strong attention to detail, highly organized and the ability to multitask in a fast-paced, highly interactive environment.
• 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 classify GxP related documentation correctly based on purpose and scope.
• Excellent verbal and written communication skills, and the ability to effectively collaborate with peers including scientific/technical colleagues.
• Ability to identify and/or resolve quality issues/discrepancies with others in a proactive, diplomatic, flexible, and constructive manner.
• 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.
• Ability to author, review, and interpret Standard Operating Procedures (SOPs).

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 [email protected].
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.