Manager, Quality Systems

Title:                                    Manager Quality Systems
Reports To:                        Associate Director, Quality Systems
Location:                            Redwood City, California
Classification:                   Exempt

Overview:
The Quality Systems Manager is responsible and accountable for ensuring Coherus’ Quality Management System (QMS) is in compliance with applicable GxP regulations, guidance, industry standards, best practices or laws. This position will lead and direct QMS activities at Coherus that facilitates disposition, regulatory filing and launch of Coherus products.

Principal Responsibilities and Duties:
Note: The following is meant to be representative but not necessarily all inclusive of the duties and responsibilities for this position title:

• Develop, operate and maintain the effectiveness of the Coherus Quality Management System (QMS) including but not limited to
• Document Control
• Training
• Deviations
• Change Controls
• CAPAs
• Establish and maintain programs that ensure the verification, monitoring and effectiveness of the QMS and its compliance to applicable regulations and standards
• Ensure timely identification, escalation and resolution of Quality issues. Alert management of product quality operation issues for proper and timely escalation to Product Quality Review Board (PQRB) and Management Review.
• 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 Quality
• Partner/team with stakeholders across the organization to address quality related issues and processes and participate in regularly scheduled meetings with CMOs
• Support late stage development activities including process validation and regulatory agency preapproval inspections (PAI) preparations
• Participate in CMC teams supporting the filing and launch of Coherus products
• Assist on Quality audits of Coherus CMOs and supplier
• Establish, maintain and report metrics to evaluate the Quality performance of CMOs
• Support Quality Management with other duties, as required.

Experience, Education, Training, Traits:

• Bachelor of Science degree or work experience equivalent to a minimum of 5 years of experience in a GMP quality (Mfg/QA/QC) environment
• Minimum of 3 years of experience working with CMOs and driving process improvements
• Strong knowledge of FDA guidelines and regulations regarding cGMPs
• Strong knowledge and demonstrated practice of ICH Guidelines
• Strong experience in establishing and maintaining a QMS
• Exercise sound and independent judgment and decision making
• Exceptional attention to detail
• Excellent interpersonal and communication skills
• Effectively interact with multi-disciplinary functional groups
• Ability to work in a fast-paced, dynamic environment
• Strong computer skills, including all MS Office applications

Language Skills:

• Ability to write reports, presentations and email correspondence. Must effectively present information and respond to correspondences from managers, program management and CMOs.

Beginning July 19, 2021, Coherus BioSciences requires all new hires to be fully vaccinated against COVID-19 as of their start date.  This requirement is a condition of employment at Coherus BioSciences, and it applies regardless of whether the position is located at a Coherus BioSciences facility or is fully remote.  If you are unable to receive the vaccine due to a disability or serious medical condition, or because it is prohibited as a result of your sincerely held religious beliefs, you will have an opportunity to request a reasonable accommodation.