Manager/Sr. Manager, Technical QA

Location
Hayward, CA
Posted
May 09, 2022
Ref
or3Cjfw9
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time

Manager/Sr. Manager, Quality Assurance


Summary:

We are seeking a highly motivated individual with experience in a CMC or Quality function to support antibody development and manufacturing.  This is an excellent opportunity for the right individual with a mindset of growth, collaboration, and continuous improvement.  The Manager/Senior Manager will provide expertise of phase-appropriate Quality principles to ensure Arcus’ products and procedures are compliant with applicable regulations and aligned with industry’s best practices. 


Job Responsibilities:

  • Responsible for providing QA oversight of technical activities, including review of protocols, reports, and methods that support Analytical, Drug Substance, and Drug Product development activities.
  • Manage internal and external Quality events such as deviations, change control, CAPAs, SCARs.
  • Establish and manage systems that support QA’s business operations, such as quality metrics and various trackers.
  • Perform batch release, EBR, QC release/stability data review, as needed.
  • Clearly and effectively communicate Quality decisions and participate in cross-functional forums as a Quality representative.
  • Support internal and external audits, health authority inspections, and partner audits as appropriate.
  • Review regulatory submissions and RTQs as appropriate.
  • Champion a Quality culture within the organization while fostering a collaborative environment with both internal and external partners.


 Qualifications (including knowledge & skills):

  • Bachelor’s degree in Life Sciences with 5+ years (Manager) or 7+ years (Sr. Manager) of experience in a technical QA or related function (e.g., PD, AS, MSAT or QC). 
  • Experience with biologics development, manufacturing, tech transfer, and validation in a pharmaceutical setting strongly preferred. 
  • Excellent understanding of GMPs, knowledge management, and risk management as applicable at various stages of pharmaceutical development.
  • Experience managing development and manufacturing activities at CDMOs.  
  • High proficiency with modern computerized systems (MS Office, Teams, Veeva, Smartsheet, etc). Previous experience as system owner a plus.
  • Ability to work independently and in a fast-paced environment.  Demonstrates integrity, responsibility, and accountability.
  • Excellent written and verbal communication skills.

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