Our client 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.  This role will be directly supporting a product for Government, DOD and International COVID Vaccine Trial.

Job Duties:

The QA Manager, Device CMO, 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 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. In this role you will perform 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.

Provide Quality oversight of CMOs, ensuring CMOs maintain quality systems that are in the state of compliance and aligned with 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 s systems, including initial QA qualification and approval and ongoing Quality Management.
• Partner with 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 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.

Job Requirements:

• 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 preferre
• Hands-on experience in a CMO or QA oversight of C
• 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 managemen
• Independent decision-making capability and ability to think strategically and understand broader impact of decisions.
• Experience in Microsoft Excel and PowerPoint

Benefits:

• Robust Benefits Package
• Work for Innovative biotechnology company focused on the discovery, development, and commercialization of its synthetic DNA technology targeted against cancers and infectious diseases.  Be part of the Solution for the prevention of Covid19!

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