Orca Bio

Orca Bio

Manager, Quality Control

Sacramento, CA · Full-time

Sponsorship not specified$100k-$145kDetected 36 days ago
ProcurementControlsGMPFDA RegulatoryFlow CytometryLeadershipCommunication

About the role

  • The Manager, Quality Control is responsible for providing oversight for the GMP testing of cell therapy products and critical intermediates.
  • This position will work cross-functionally to ensure that products are sampled and tested under applicable regulations and guidelines of current Good Manufacturing Practices (cGMPs).
  • There are regular interactions with internal manufacturing and with service providers.

Responsibilities

  • Lead GMP testing operations and meet critical business goals.
  • Perform data reviews and release completed test results.
  • assess, plan and manage resource allocations for QC
  • Hire, mentor and develop QC personnel, including QC Supervisors.
  • Contribute to the design, implementation and continuous improvement of Quality Control systems that are technically sound, promote effective and efficient operations, comply with cGMP requirements and meet commercial stage standards.
  • Provide leadership support during trouble shooting of assay performance and equipment as it relates to ensuring the quality and compliance of the product.
  • Collaborate with analytical development on updates and validation of test methods. Define method trending metrics and perform method trending
  • Define requirements and lead equipment qualification, maintenance and calibration practices and manage instrument capacity
  • Contribute and lead direct interactions with Regulatory agencies (audits, etc.).
  • Ability to identify and elevate issues and support solutions.

Requirements

  • 7+ years of relevant experience in quality control, or a related field such as analytical development or quality assurance and a BS or BA
  • or 5+ years of relevant experience and a MA/MS/MBA.
  • At least 2 years of experience managing personnel.
  • Knowledge of global regulatory requirements, guidance and best practices for biopharmaceuticals and advanced therapies such as cell and gene therapies.
  • Experience and knowledge of environmental monitoring programs, including ISO 14644 and EU Annex 1.
  • Experience with the application of cGMPs, USP/NF, FDA guidelines, EU regulations and ICH guidelines in the pharmaceutical industry.
  • Experience with standard biologic safety testing, e.g. endotoxin and sterility per USP.
  • Experience with implementation and use of LIMS and other quality management system software
  • experience with implementing, improving and ensuring robust data integrity approaches.
  • Experience in preparing for and participating in quality and regulatory audits.

Nice to have

  • Experience with flow cytometry and cell therapies is strongly preferred.

Compensation

  • The anticipated annual salary range for this job is based on prior experience in the role/industry, education, location, internal equity, and other job-related factors as permitted by law.

Company info

  • We are driven by a passion for science and compassion for patients.
  • We act with urgency to ensure our treatments are one day accessible to all who need them.
  • We live by our core values of passion, courage, and integrity.
  • Excellence in our work means the chance to unlock a better quality of life for our patients, and with that comes tremendous responsibility.
  • We innovate on a path that hasn't been paved.
  • We embrace an entrepreneurial spirit and take calculated risks to achieve our mission.
  • We aren't afraid to ask "why not" and challenge the status quo.
  • We maintain a start-up culture of camaraderie and leadership by example, regardless of title.
  • We're proud to be an equal opportunity employer, and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients and their healthcare providers.
  • Notice to staffing firms Orca Bio does not accept resumes from staffing agencies with which we do not have a written agreement and specific engagement for a particular opening.
  • Our employment activities, inquiries and offers are managed through our HR/Talent team, and all candidates are presented through this channel only.
  • We do not accept unsolicited resumes, and we rarely outsource recruitment.
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