Manager/Senior Manager, Quality Assurance
Company: Coherus Biosciences Inc
Location: Redwood City
Posted on: September 17, 2023
Title: - - - - - - - - - - - - - - - Manager/Senior Manager,
Quality AssuranceReports To: - - - - - - - - - - Director, Quality
Assurance Operations Location: - - - - - - - - - - - - Redwood
City, California Classification: - - - - - - - - Exempt -
The Manager/Senior Manager, Quality Assurance, represents the
quality organization at Coherus and at Contract Manufacturing
Organizations (CMOs) to ensure appropriate oversight/monitoring of
production, and ensure continuous supply of clinical and commercial
Note: - The following is meant to be representative but not
necessarily all inclusive of the duties and responsibilities for
this position title:
- Good knowledge base and direct experience in biopharmaceutical
manufacturing of Drug Product / Final Packaged Product and QA
- Review and approval of cGMP documentation, such as master batch
records, executed production records, certificates of analysis, and
any other quality related records, to support the disposition of
- Participate in validation / tech transfer activities.
- Participate in regularly scheduled meetings with CMOs.
- Drive and troubleshoot quality investigations at CMOs to ensure
that all critical quality issues are fully investigated with
- Alert management of product quality operation issues for proper
and timely escalation to Product Quality Review Board (PQRB) and
- Quality review of documents from CMOs for compliance with
Coherus BioSciences policies/procedures and cGMP's.
- Manage CAPA and Change Controls to support release of Coherus
- Participate in development and continuous improvement
initiatives of QA processes and SOPs.
- Maintain the effectiveness of the Coherus Quality Management
System (QMS) including but not limited to
- Change Control
- Provides audit support of Coherus BioSciences CMOs, as
- Contribute to process improvement initiatives across
organization and provide support and direction to maintain quality
system to recognized standards.
- Partner/team with stakeholders across the organization to
address compliance related issues and processes.
- Support Quality Management with other duties, as required.
- Bachelor of Science degree or work experience equivalent to a
minimum of 5-7 years of experience in a GMP quality (Mfg/QA/QC)
environment, experience in drug substance. Drug product and final
packaged product a plus.
- Minimum of 3 years of experience working with contract
manufacturing organizations and driving process
- Prior experience in disposition of biopharmaceutical
- Strong knowledge of FDA guidelines and regulations regarding
- Strong knowledge and demonstrated practice of ICH
- Exceptional attention to detail.
- Outstanding written, verbal skills and problem solving
- Strong computer skills, including all MS Office
- Effectively interact with multi-disciplinary functional
- Exercise sound and independent judgment and decision
- Ability to work in a fast-paced, dynamic environment.
- Up to -30% travel required for this position, typically
Ability to write reports, presentations and email correspondence. -
Must effectively present information and respond to correspondents
from managers, program management and CMOs.
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 opportunity
to directly contribute to the companies' 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 $110,000 - $170,000
Coherus considers various factors, including professional
background and work experience, when determining base pay. These
considerations mean actual compensation will vary.
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. -
Keywords: Coherus Biosciences Inc, Redwood City , Manager/Senior Manager, Quality Assurance, Executive , Redwood City, California
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