INOVIO is a biotechnology company focused on rapidly bringing to market precisely designed DNA medicines to treat and protect people from infectious diseases, cancer, and diseases associated with HPV. INOVIO is the first and only company to have clinically demonstrated that a DNA medicine can be delivered directly into cells in the body via a proprietary smart device to produce an efficacious, robust and tolerable immune response. Partners and collaborators include Advaccine, ApolloBio Corporation, AstraZeneca, The Bill & Melinda Gates Foundation, Coalition for Epidemic Preparedness Innovations (CEPI), Defense Advanced Research Projects Agency (DARPA)/Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND)/Department of Defense (DOD), HIV Vaccines Trial Network, International Vaccine Institute (IVI), Medical CBRN Defense Consortium (MCDC), National Cancer Institute, National Institutes of Health, National Institute of Allergy and Infectious Diseases, Ology Bioservices, the Parker Institute for Cancer Immunotherapy, Plumbline Life Sciences, Regeneron, Richter-Helm BioLogics, Roche/Genentech, Thermo Fisher Scientific, University of Pennsylvania, VGXI, Walter Reed Army Institute of Research, and The Wistar Institute. For more information, visit www.inovio.com.
The Manager, Device CMO, Quality Assurance is responsible for managing the quality oversight of device contract manufacturing organizations (CMO) to ensure that all aspects of the products comply with requirements of INOVIO’s QMS and meet relevant cGMP requirements. The QA Device CMO Manager is responsible as Quality point-of-contact and SME to ensure quality of product / process transfers, validations, issues investigations, tracking and resolution occur in a timely manner as well as Quality support for process improvements and any outsourcing required to support product release. The QA Device CMO Manager performs quality review of batch records, release data, non-conformances, Deviations, Investigations and any validation protocol/reports associated with product lot release to ensure products were manufactured according to cGMP. The QA Device CMO Manager also reviews and performs data trending of multiple products.
Essential job functions and duties
- Provide Quality oversight of CMOs, ensuring CMOs maintain quality systems that are in the state of compliance and aligned with INOVIO expectations and contract requirements.
- Assist with the management of Device CMO supplier audits and qualifications.
- Perform quality review of CMO generated documents including, but not limited to, manufacturing batch records, in-process data, release data, packaging and labeling records, validation protocols/reports and cGMP compliance and completeness.
- Work closely with CMO team for management of integration for new CMOs into INOVIO’s systems, including initial QA qualification and approval and ongoing Quality Management.
- Partner with INOVIO internal Supplier Management, Regulatory, Supply Chain and Operations teams to ensure CMO compliance to Internal and External requirements.
- Manage GMP Lot Release activities, perform batch record review and lot disposition activities as required and review or coordinate certificates of release and final approvals for all CMO quality documentation.
- Assist with and provide QA approval of investigations, CAPAs, changes, validation documentation, and other related GMP documentation
- Ensure the conformance of the CMO’s manufacturing, packaging, or testing processes to cGMP, company policies and procedures, as well as INOVIO’s specific requirements
- Coordinate presentations of CMO data and quality metrics for regular trending, review and evaluation.
- Drive periodic review of Quality Systems at the CMO, to complement audit process. Act as Quality SME to assist or conduct root cause analysis reviews for identification of issues and development of remedial actions as related to CMO activities.
- Ensure that investigations associated with assigned third party sites are properly carried out, resulting in sustainable CAPA, documented, evaluated, and closed as efficiently as possible, and in respect with the procedure. Support and lead internal audit processes where required.
- Lead Quality Agreement negotiations with CMO/ External Supplier and implement Quality Systems performance management with appropriate KPIs for contractual parameters.
- Perform other duties as assigned.
- Bachelor’s Degree in Engineering preferred or an equivalent combination of education, training, and/or experience from which comparable knowledge, skills and abilities have been attained.
- Minimum 5 years of experience in a QA or QE role supporting manufacturing.
- Minimum 5 years biotech or medical device industry experience preferred.
- Hands-on experience in a CMO or QA oversight of CMO.
- Knowledge and/or experience with cGMP, QSR, ISO 13485 and MDR/
- Detail-orientated for compliance issues in GMP records.
- Effective oral and written communication skills.
- Advanced skills in leading, negotiating, and supplier management.
- Independent decision-making capability and ability to think strategically and understand broader impact of decisions.
- Experience in Microsoft Excel and PowerPoint
- Excellent interpersonal and strong organizational abilities, including ability to follow multiple assignments through to completion.
- Ability to work in a team environment including external team members.
- Maintain a high level of confidentiality.
- Demonstrate professional demeanor.
- Work independently on a broad variety of projects.
- Adapt to changing needs and situations.
INOVIO Pharmaceuticals, Inc. is committed to a policy of equal employment opportunity. In keeping with our policy, INOVIO will recruit, hire, train and promote into all job titles the most qualified individuals, without regard to race, color, creed, gender, gender identity and expression, religion, marital status, registered domestic partner status, age, national origin or ancestry, military or veteran status, physical or mental disability, medical condition including genetic characteristics, sexual orientation, or any other consideration made unlawful by federal, state, or local laws.
A current US work authorization is required. The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. INOVIO offers an attractive benefits package and is an equal opportunity employer.
Important notice to employment businesses/agencies
INOVIO does not accept referrals from employment agencies unless written authorization from the INOVIO Human Resources department has been provided. In the absence of written authorization, any actions undertaken by employment agencies shall be deemed to have been performed without our consent and therefore INOVIO will not be liable for any fees arising from employment agency referrals in respect to current or future position vacancies at INOVIO.