Director, Product Complaints (QA Operations)

Title:                                     Director, Product Complaints (QA Operations)
Reports To:                         Vice President, QA Operations
Location:                             Redwood City, California
Classification:                    Exempt  
 
Overview:

The Director, Product Complaints operates with limited supervision to ensure compliance with Choreus’s Global Product Complaint Management Process. This position oversees the complaint management process from intake to closure, as well as monitoring and trend reporting as part of surveillance and quality management review processes. This individual oversees the training of the product complaint system to applicable staff and is the subject matter expert for day-to-day processing issues. Utilizes sound judgement to develop and recommend solutions to a variety of moderately complex quality events and issues related to the complaint management process. Investigates process related failures using the deviation system and implements CAPAs when appropriate. Conducts QA duties in compliance to global SOPs, cGMP’s and in accordance with company policies, procedures, and federal regulations.  This position may have managerial responsibilities, depending on the candidate, and will oversee staff development and day to day activities, as assigned.

Principal Responsibilities

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

• Ensures complaints are processed in compliance with Coherus ’s Global Product Complaint program activities as required by SOPs as well as cGMP regulations.
• Performs and oversees the daily Product Complaint processing activities including: complaint initiation, due diligence, investigation assignment, investigation closure, complaint closure, and the identification of potential Quality risks and/or trends for escalation to management.
• Owns and manages higher risk complaints with guidance from the Head of QA.
• Responsible for training staff on the complaint processes.
• Ensures reconciliation of complaints between Global Drug Safety and External Coherus Partners are conducted per governing procedures and Quality Agreements.
• Initiates and manages deviations related to the Global Product Complaint process as required and in collaboration with local/global Quality staff.
• Prepares data to support Quality/Operational metrics and highlights risks to Senior Management.
• Supports internal and regulatory body inspections, as needed.
• Create, review and revise SOP’s, as applicable to job functions.
• Oversee staff development and day-to-day activities.

Qualifications

• Bachelor’s degree or work experience equivalent to a minimum of 10 years of experience in the pharmaceutical/Biological industry.
• 7 years of demonstrated direct Quality/QA experience in a cGMP environment.
• Prior experience leading teams, working in a matrixed environment and mentoring staff, is preferred.
• Experience with product quality complaint management systems for combination products with drug and medical device component experience preferred.
• Strong Knowledge of FDA guidelines and regulations regarding cGMPs for biological drug products, medical devices, and combination products.
• Exercise sound and independent judgment and decision making.
• Excellent interpersonal and communication skills.
• Exceptional attention to detail.
• Strong computer skills, including EDMS systems and 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.

Language Skills:

Ability to write reports, presentations, and email correspondence.  Must effectively present information and respond to correspondence from managers, program management and other groups both internal and external as required.

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 the opportunity to directly contribute to the company’s 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.

The Base Salary Range for this position is $190,000 - $240,000. 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.

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. 

** We are currently not accepting any unsolicited resumes from recruiters or employment agencies. **