Executive Director, Head Of Quality Control

Coherus Biosciences Redwood City , CA 94063

Posted 3 months ago

Title: Executive Director, Head of Quality Control

Reports To: Head of Quality

Location: Redwood City, California

Classification: Exempt

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 significant 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:

Note: The following is meant to be representative but not necessarily all inclusive of the duties and responsibilities for this position title:

  • Oversee the operations of all Quality Control activities for internal and external testing activities.

  • Provide input and guidance to strategic partners as needed.

  • Represent the QC organization in interactions with other functional units. 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 reports

  • Travel as required, both domestically and internationally, to ensure compliance to the Company's Quality Management Systems

Experience, Education, Training, Traits:

  • BS degree in relevant scientific discipline or technical field is required; advanced degree is preferred.

  • A minimum of 12 years of hands on experience in a Quality organization within the biotechnology industry is preferred, which shall include at least 8 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 compliance.

  • Extensive knowledge of GMP quality systems and regulatory compliance.

  • 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 commitments.

  • Possesses the strongest ethics and integrity.

  • 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.

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.


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Executive Director, Head Of Quality Control

Coherus Biosciences