Title:                               Manager/Senior Manager, Quality Assurance
Reports To:                     Associate Director, Quality Assurance Operations
Location:                         Redwood City, California
Classification:                 Exempt 
 
Overview:

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

Responsibilities:

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 Drug Substance/API production and QA oversight.
• Review and approval of cGMP documentation, such as master batch records, executed production records, certificates of analysis, and any other quality related records, to support the disposition of Coherus products.
• Participate in validation / tech transfer activities.
• 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 Coherus products.
• Participate in development and continuous improvement initiatives 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.

Qualifications:

• 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 biopharmaceutical 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.

As an employee of Coherus, you will actively contribute to the development of potential new products. We provide opportunities for all employees to collaborate, offering visibility and opportunity to directly contribute to the companies’ success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking and work-life balance. Our competitive compensation and benefit programs and stock options reflect Coherus’ high regard for our employees.

The Base Salary Range for this position is $110,000 - $170,000 Coherus considers various factors, including professional background and work experience, when determining base pay. These considerations mean actual compensation will vary.

Coherus provides equal employment opportunities to all employees and applicants for employment and prohibits unlawful discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. We also prohibit discrimination based on the perception that anyone has any of these characteristics or is associated with a person who has or is perceived as having any of these characteristics.