Manager, Quality Assurance
Company: Coherus BioSciences
Location: Redwood City
Posted on: January 21, 2023
Title: Manager, Quality AssuranceReports To: Senior Vice
President, Pre-Commercial Quality AssuranceLocation: Redwood City,
California Classification: Exempt Overview: The Manager, Quality
Assurance, represents the quality organization at Coherus and at
Contract Manufacturing Organizations (CMOs) to ensure appropriate
oversight/monitoring of production and ensure pre-commercial
products supply from early development through commercialization.
Responsibilities: 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 of biopharmaceutical
manufacturing of intermediates and finished product (i.e., WCB/MCB,
drug substance, drug product, final packaged product) and QA
- Review and approval of cGMP documentation, such as master batch
records, executed production records, certificates of analyses,
quality systems records, to support the disposition of Coherus
- 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 cGMPs.
- Manage CAPA and Change Controls to support release of clinical
- Support the final disposition activities of
- Support manufacturing process transfers, as well as, process
validation activities for late phase clinical programs.
- Support inspection readiness and commercialization activities
to include BLA authoring, date verification and information request
- Participate in development 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 QA experience in a GMP (Mfg/QA/QC)
- Minimum of 3 years of experience working with contract
manufacturing organizations and driving process improvements.
- Prior experience in disposition of biopharmaceutical products.
Clincal product disposition preferred.
- 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 campaign
based. The Base Salary Range for this position is $110,000 -
$140,000. 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, Redwood City , Manager, Quality Assurance, Executive , Redwood City, California
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