Director/Senior Director, Head of Commercial Quality Control

Title: Director or Senior Director, Head of Commercial Quality Control

Reports To: Head of Quality Control

Location: Redwood City, California

Classification: Exempt

Overview:

The Head of Commercial Quality Control will be responsible for all Quality Control procedures and systems for Coherus' commercial manufacturing and testing CMO network. Primary responsibilities include oversight of commercial testing, test demand/capacity, and testing cycle time reductions. The incumbent would be the single point of Contact for the Company with the commercial testing network and will be responsible for the generation, review and compilation of Quality Control required reports, manuals and SOP's; development and maintenance of Quality Agreements with key commercial contract testing labs. The incumbent must have hands on experience in the development, establishment, management, and defense of commercial Quality Control systems. Superb quality documentation generation skills and proven communication skills, as well as significant experience in the biopharmaceutical industry, are critical.

Responsibilities:

Represent Quality Control on internal project teams and represent Coherus Quality Control to Contract Laboratory Quality counterparts. Develop and review product Certificate of Analysis, Test methods and assay history records. Assist in audits as needed and represent Coherus during regulatory inspections of contract laboratories. Independently manage method transfer process effectively to deliver analytical methods for protein therapeutics from one site to another. Coordinate validation and testing activities for release, stability and in-process methods to support the manufacture of protein therapeutic product suitable for FDA and other regulatory agency licensure.

Specific duties:

• Oversee the operations of all commercial Quality Control activities globally for internal and external testing activities.
• Oversee and support method validation and verification activities, and method transfer between sites for commercial products.
• Represent the Quality Control organization in interactions with other key commercial functional units as well as with external contract testing labs.
• Manage QC deviations, CAPAs, and change controls for commercial Coherus products.
• Manage QC inputs to Annual Product Quality Reviews, Quality Management Reviews, Product Quality Reviews
• Oversee trending of commercial product quality (Drug Substance, Drug Product, Finished Product) and commercial QC analytical method performance.
• Develop or improve Coherus commercial Quality Control standards/process as member of the QC team.
• Conduct GMP audits of commercial CMO's and testing laboratories.
• Serve as Coherus liaison during regulatory inspections of contract labs.
• Lead and /or review laboratory deviation evaluation and resolution activities as required
• 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.

Qualifications:

• Bachelor Degree in Engineering, Chemical or Life Sciences. Advanced degree preferred.
• A minimum of 8-10 years' hands on experience in a Quality organization within the biotechnology industry is preferred, which shall include 5 years' hands on experience in managing Quality groups (both internal and external).
• Expert knowledge of global cGMP expectations, ICH Quality requirements, and USP/EP/JP.
• 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 autonomously and manage effectively in a matrix 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, matrix work environment.
• Expert analytical method development experience highly desired.
• 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.
• Experience authoring CMC portions of regulatory filings is highly desired.
• Comfortable working in a fast paced and highly expert environment.
• Excellent communication skills and comfortable assuming leadership within teams and with external CMO's.

At Coherus, our employees are our most important asset. We have a dynamic and rewarding organizational culture that offers the opportunity to work with leading industry professionals who are dedicated to making a difference for patients. We are looking for individuals who see unlimited potential in themselves and are motivated by a continuous passion for breaking down barriers and expanding access to lifesaving therapeutics.

Coherus offers a competitive total rewards program comprised of various elements, including competitive base pay, short- and long-term incentives in the form of performance-based cash and equity, as well as health and wellness benefits that include

• Healthcare: Coherus pays 90% of premiums for medical, dental, and vision coverage for our employees, their eligible spouses, dependents, and domestic partners.
• Health Savings and Flexible Spending Accounts
• Group Life, Disability, and Group Accident Insurance
• 401(k) with company match, and an Employee Stock Purchase Plan (ESPP)
• Paid Time Off (PTO)
• Health & Wellness programs, including a Health Club Reimbursement and an Employee Assistance Program

The Base Salary Range for this position is $185,000 - $250,000. Coherus considers various factors, including professional background and work experience, when determining base pay. These considerations mean actual compensation will vary.

In addition to providing attractive rewards packages, we encourage and support our employees to find the right balance of work and personal time. Coherus offers a variety of activities, perks, and holidays that encourage employees to have a healthy outlook, spend time outside of work with friends and family, and foster a productive and collaborative work environment. Our culture is one in which we challenge and support all our team members to do their best work.

For more information about Coherus, please check out: https://www.coherus.com/about-coherus/

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.