Associate Director, Commercial Quality Assurance, Drug Substance

Title:                                     Associate Director, Commercial Quality Assurance, Drug Substance
Reports To:                         Sr. Director, Commercial Quality Assurance
Location:                             Redwood City, California
Classification:                    Exempt

Overview:  

The Associate Director, Commercial QA represents the commercial activities at Coherus and at Contract Manufacturing Organizations (CMOs) to ensure overall compliance that facilitates disposition, regulatory fillings and supply of Coherus Commercial 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:

• Strong knowledge base and direct experience for Commercial Drug Substance/API production and QA oversight. Experience in Drug Product and Final Packaged Product production a plus.
• Lead Quality and Compliance initiatives for Drug Substance (DS) CMO that ensure the timely disposition of Commercial products in support of company objectives.
• Review and approval of master batch records to support the disposition of Coherus commercial products.
• Responsible for final release activities for commercial products.
• Responsible for final approval of Change Controls, Deviations and CAPAs for Commercial QA DS.
• Participate/Lead regularly scheduled meetings with CMO – both specific to QA and with cross-functional groups.
• Identify and ensure timely communication/escalation to Sr. Management for product quality issues - including escalation to Product Quality Review Board (PQRB), Quality Management Review (QMR) and Product Quality Review (PQR) forums.
• Jointly lead Coherus BioSciences’ vendor management performance metrics at CMOs with Coherus Technical Operations group.
• Direct the development of Commercial QA processes and SOPs including support for development of processes and SOPs by process owners outside QA.
• Maintain and drive process improvements to ensure the effectiveness of the Coherus Quality Management System (QMS) including but not limited to:
• Deviations/PQRB
• Change Control
• CAPA
• Commercial Batch Review/Release
• Provide audit support of Coherus CMOs and Suppliers as required.
• Identify, maintain, and team with stakeholders across the organization & at CMOs to address compliance related issues and processes.
• Partner/team with stakeholders across the organization to address compliance related issues and processes.
• Establish, maintain and report internal metrics to evaluate Quality performance for Commercial products.
• Train new QA staff as required.
• Support Quality Sr. Management with other duties, as required.

Experience, Education, Training, Traits:

• Bachelors of Science degree or work experience equivalent to a minimum of 7-9 + years (Mfg/QA) experience in the pharmaceutical/Biological industry, with experience in drug substance, drug product and final packaged product.
• Minimum of 5 years of experience in managing CMOs and driving process improvements.
• Prior experience in disposition of Commercial products.
• Strong Knowledge of FDA guidelines and regulations regarding cGMPs.
• Strong knowledge and demonstrated practice of ICH Guidelines.
• Exercise sound and independent judgment and decision making.
• Excellent interpersonal and communication skills.
• Exceptional attention to detail.
• Strong computer skills, including all MS Office applications.
• Exceptional ability to partner cross-functionally with different teams and projects.
• Strong initiative and ability to assume significant project management skills.
• 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.

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.