Representing the quality organization in oversight and monitoring of the GMP production in contract manufacturing sites to ensure product specifications are met.
Principle Responsibilities and Duties:
- Review and approval of batch records to support the disposition of Coherus products
- Drives and troubleshoots quality investigations at contract manufacturers to ensure that all critical quality issues are fully investigated with appropriate action. Alert management of product quality operation issues for proper and timely escalation to Product Quality Review Board (PQRB) and Management Review.
- Manage CAPA and Change Controls to support release of products by Coherus
- Ensures contract manufacturers are compliance ready for regulatory inspections and monitor inspection progress during inspections.
- Quality review of documents from contract manufacturers for compliance with Coherus BioSciences policies/procedures and cGMP’s.
- Execute and oversee Coherus BioSciences vendor management key performance indicators at contract manufacturers.
- Identify, maintain, and team with stakeholders across the organization & at CMO’s to address compliance related issues and processes.
- Ensure quality checks on operations in progress at contract manufacturers Drug Product, Device Assembly, Labeling and Final Packaged Product.
- Carry out final release activities for manufactured products.
- Provides auditsupport of Coherus BioSciences contract manufacturers as required.
- Identify, create and implement process and system improvements.
- Establishes and maintain programs that ensure the verification, monitoring and effectiveness of the QMS and its compliance to applicable regulations and standards
- Participate in regularly scheduled meetings with CMOs.
- Contribute to process improvement initiatives across organization - provide support and direction to maintain quality system to recognized standards - direct and/or participate in development of QA processes and SOPs - support development of processes and SOPs by process owners outside QA
- Establish, maintain and report metrics to evaluate the Quality performance of CMOs
- Support Quality Management with other duties, as required
Experience, Education, Training, Traits:
- Bachelordegree in Sciences, or comparable experience, with minimum of 8-10 years of experience in a GMP quality (QA/QC) environment, experience in drug product/device/labeling and final packaged product manufacturing.
- Minimum of 3-5 years of experience in managing contract manufacturing organizations and driving process improvements.
- Strong leadership and negotiation skills.
- Excellent interpersonal and communication skills.
- Exceptional ability to partner cross-functionally with different teams and projects.
- Exercise sound and independent judgment and decision making.
- Exceptional attention to detail.
- Travel to CMO site as required: Travel will be ~20-30%, typically campaign based.