Senior Manager, Pre-Commercial Quality Assurance

Title:                                     Senior Manager, Pre-Commercial Quality Assurance
Reports To:                         SVP, Pre-Commercial Quality Assurance
Location:                             Redwood City, California
Classification:                    Exempt 
 
Overview:

Senior Manager, Pre-Commercial Quality Assurance, represents the quality organization at Coherus and at Contract Manufacturing Organizations (CMOs) to ensure appropriate oversight/monitoring of production and ensure clinical supply.

Principle 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:

• Good knowledge base and direct experience for clinical Drug Substance/API production and QA oversight.
• Review and approval of batch records to support the disposition of Coherus clinical products.
• Participate in regularly scheduled meetings with CMOs.
• Drive and troubleshoot quality investigations at CMOs to ensure that all critical quality issues are fully investigated with appropriate actions.
• Alert management of product quality operation issues for proper and timely escalation to Product Quality Review Board (PQRB) and Management Review.
• Quality review of documents from CMOs for compliance with Coherus BioSciences policies/procedures and cGMP’s.
• Manage CAPA and Change Controls to support release of clinical products.
• Participate in development of QA processes and SOPs.
• Maintain the effectiveness of the Coherus Quality Management System (QMS) including but not limited to
• Deviations
• Change Control
• CAPA
• Provides audit support of Coherus BioSciences CMOs, as required.
• Contribute to process improvement initiatives across organization and provide support and direction to maintain quality system to recognized standards.
• Partner/team with stakeholders across the organization to address compliance related issues and processes.
• Support Quality Management with other duties, as required.

Experience, Education, Training, Traits:

• Bachelor of Science degree or work experience equivalent to a minimum of 5-7 years of experience in a GMP quality (Mfg/QA/QC) environment, experience in drug substance. Drug product and final packaged product a plus.
• Minimum of 3 years of experience working with contract manufacturing organizations and driving process improvements.
• Prior experience in disposition of clinical products.
• Strong knowledge of FDA guidelines and regulations regarding cGMPs.
• Strong knowledge and demonstrated practice of ICH Guidelines.
• Exceptional attention to detail.
• Outstanding written, verbal skills and problem solving skills.
• Strong computer skills, including all MS Office applications.
• Effectively interact with multi-disciplinary functional groups.
• Exercise sound and independent judgment and decision making.
• Ability to work in a fast-paced, dynamic environment.
• Up to ~30% travel required for this position, typically campaign based.

Language Skills:

Ability to write reports, presentations and email correspondence.  Must effectively present information and respond to correspondents 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.