Overview:

This position is responsible for the Quality Control organization at Coherus and will have full accountability and responsibility for staff and operations including the activities and strategies supporting precommercial program development and commercial program lifecycle management. This position plays an integral role in the success of the company and must be well versed in all phases of the commercialization process, possess strong leadership capabilities to lead teams and influence senior leaders across the organization, experience to apply cGMPs and multi-national regulations in day to day decision-making to ensure deliverables meet regulatory expectations and operations are maintained in a fully compliant and audit ready state, and have signficant experience with the analytical methods and tools used in modern control systems for monitoring and assessing the quality attributes of biologics for drug substance, drug product and final finished product including combination products with a device component.

Primary responsibilities include leading the development and implementation of a comprehensive Quality management plan for QC and being the final decision maker for QC inputs and deliverables; generation, review and compilation of required reports, manuals and SOP’s; development and maintenance of Quality Agreements with key contract testing labs; serving as QC lead on audits and Agency inspections, partner with other colleagues across the company on due diligence evaluations and contribute to regulatory submissions and agency interactions.

The incumbent must have hands on experience in the development, establishment, management, and defense of QC systems, both internally and externally, as well as extensive knowledge, understanding and application of QC systems for combination products. Superb quality documentation and proven communication skills, as well as significant experience in the biopharmaceutical industry, are critical.

Principal Responsibilities and Duties:

• Oversee the operations of all Quality Control activities for internal and external testing
• Provide input and guidance to strategic partners as
• Represent the QC organization in interactions with other functional These include Regulatory Affairs, Clinical, Project Management, Manufacturing, Finance, etc.
• Establish, oversee, and manage QC documentation systems including but not limited to, change control, SOPs, protocols/reports, training records, job descriptions etc.
• Lead the implementation of a QC Systems that will assure that all aspects of Quality Control testing are in compliance with CMC requirements as well as internal SOP’s.
• Assist the Company with the development and management of a comprehensive budget for Quality Control activities.
• Provide mentorship to direct reports and maintain clear communication on performance to direct
• Alert executive management of product quality issues for proper and timely escalation to Product Quality Review Board (PQRB) and Management Reviews.
• Serve as a Senior Management representative on Quality Management Reviews (PQR, QMR and APQR) and work with team to identify and address risks associated with the execution of the QMS and performance of the applicable products.
• Travel as required, both domestically and internationally, to ensure compliance to the Company’s Quality Management Systems

Qualifications:

• BS degree in relevant scientific discipline or technical field is required; advanced degree is
• A minimum of 15 years of hands on experience in a Quality organization within the biotechnology industry is preferred, which shall include at least 10 years of hands on experience in managing QC organizations/groups.
• Ability to function effectively as a member of project teams with demonstration of superior leadership skills.
• Experience with using a “phase-appropriate” approach to
• Extensive knowledge of GMP quality systems and regulatory
• Complete understanding of the commercialization of protein-based therapeutic products in the US, and preferably, Europe, Japan, and the non-ICH geographies.
• Excellent oral and written communication skills, auditing skills, and proven ability to work independently and manage effectively in a matrixed environment.
• A hands-on, “roll up the sleeves” professional willing to try innovative things, have a driving sense of urgency and an experienced “make it happen” orientation within a program-based, matrixed work environment.
• Exceptional communication skills, both written and verbal, are required. This candidate must have the communication skills and experience to effectively present the Company’s Quality programs to the FDA and other regulatory authorities from around the world.
• Articulate, persuasive and demonstrated ability to influence others, while employing sound judgment and good sense. Ability to provide clear direction in a matrixed organization.
• An exceptional leader with the strong management and leadership skills necessary to set a vision, create and lead a first class, results oriented Quality group.
• An understanding of the importance of meeting corporate and program
• Possesses the strongest ethics and
• Ability to travel both domestically and internationally, up to 25%.
• Demonstrated ability to write reports, presentations, and business correspondence and to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.

The Base Salary Range for this position is $300,000 to $340,000. 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.