Director, Quality Systems
We are seeking a highly motivated individual to join us as a Director, Quality Systems. In this role, you will manage various aspects of Coherus Quality Systems, ensure compliance with the quality system's procedures and identify and assess quality risks in activities and processes according to regulatory agency guidelines and Coherus quality practices.
- Develop operate and maintain the effectiveness of the Coherus Quality Management System (QMS) including but not limited to
- Document Control
- Change Control
- Manage and serve as system administrator for the Electronic Document Management System (EDMS) and GxP training program.
- Ensure timely identification, escalation and resolution of Quality Operation issues. Alert management of product quality operation issues for proper and timely escalation to Product Quality Review Board (PQRB) and Management Review.
- Establishes and maintain programs that ensure the verification, monitoring and effectiveness of the QMS and its compliance to applicable regulations and standards.
- Support late stage development activities including regulatory agency preapproval inspections (PAI) preparations.
- Participate in regularly scheduled meetings with contract organizations.
- Assist on Quality audits of Coherus contract organizations and suppliers.
- Provide regulatory support of Coherus products in support of company objectives.
- Contribute to process improvement initiatives across organization - provide support and direction to maintain quality system to recognized standards - direct and/or participate in development of QA processes and SOPs - support development of processes and SOPs by process owners outside QA.
- Participate in CMC teams supporting the filing and launch of Coherus products.
- Partner/team with stakeholders across the organization to address compliance related issues and processes.
- Establish, maintain and report metrics to evaluate the Quality performance of Coherus and contract organizations.
- BA/BS or MA/MS
- > 10 years QS experience in the biopharmaceutical/biotechnology industry
- Prior experience with Quality oversight of contract organizations
- Strong experience in establishing and maintaining a QMS
- Strong Knowledge of FDA guidelines and regulations regarding cGMPs.
- Strong knowledge and demonstrated practice of ICH Guidelines.
- Excellent interpersonal and communication skills.
- Ability to work in a fast-paced, dynamic environment.
- Strong computer skills, including all MS Office applications.
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.