Title: Manager, Quality Assurance
Reports To: Senior Vice President, Pre-Commercial Quality Assurance
Location: Redwood City, California
The Manager, Quality Assurance, represents the quality organization at Coherus and at Contract Manufacturing Organizations (CMOs) to ensure appropriate oversight/monitoring of production and ensure pre-commercial products supply from early development through commercialization.
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 of biopharmaceutical manufacturing of intermediates and finished product (i.e., WCB/MCB, drug substance, drug product, final packaged product) and QA oversight.
- Review and approval of cGMP documentation, such as master batch records, executed production records, certificates of analyses, quality systems 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 cGMPs.
- Manage CAPA and Change Controls to support release of clinical products.
- Support the final disposition activities of pre-commercial/commercial products.
- Support manufacturing process transfers, as well as, process validation activities for late phase clinical programs.
- Support inspection readiness and commercialization activities to include BLA authoring, date verification and information request support.
- Participate in development of QA processes and SOPs.
- Maintain the effectiveness of the Coherus Quality Management System (QMS) including but not limited to
- Change Control
- 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.
- Bachelor of Science degree or work experience equivalent to a minimum of 5-7 years of QA experience in a GMP (Mfg/QA/QC) biopharmaceutical environment.
- Minimum of 3 years of experience working with contract manufacturing organizations and driving process improvements.
- Prior experience in disposition of biopharmaceutical products. Clincal product disposition preferred.
- 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.
The Base Salary Range for this position is $110,000 - $140,000. Coherus considers various factors, including professional background and work experience, when determining base pay. These considerations mean actual compensation will vary.
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.