48 applicants

Company

Original Job Post

Kyverna Therapeutics · 3 days ago

Senior Manager, Computerized Systems Quality Assurance

Emeryville, CA

Full-time

Onsite

Senior Level

$140K/yr - $155K/yr

8+ years exp

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Responsibilities

In collaboration with various departments, support automation, document management, and learning management strategies.

Develop and maintain Kyverna's CSA program, including protocols, lifecycle management, and CSP audit support.

Manage Validation/Qualification of systems for clinical trials.

Provide expertise in investigating computerized system quality events.

Monitor key performance indicators and risk management for compliant system utilization.

Identify and resolve computerized system issues in a timely manner.

Design and implement automation levels to support programs.

Support business development due diligence projects.

Perform other assigned duties.

Qualification

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Pharmaceutical manufacturingQuality assuranceComputer systems validationGAMP 5Annex 11Part 11Lifecycle quality managementRegulatory information systemsERP systemsRisk assessmentProject managementCommunication with stakeholdersClinical communicationBiostatistical communicationPre-clinical communicationBusiness partnershipRegulatory Authorities communicationProblem-solvingStrategic thinkingHigh emotional intelligence interpersonal communication think creatively

Required

Degree (bachelor's or higher) or equivalent experience in life sciences, or computer sciences., or related field.

8+ years of pharmaceutical manufacturing and/or Quality Assurance experience, with at least 2 years' experience with computer systems validation.

Experience implementing systems compliant with GAMP 5, Annex 11, or Part 11.

Demonstrated ability to manage contract resources supporting CSV, including authoring of validation master plans and protocols, training against protocols, and writing summary reports.

Deep knowledge and experience with one or more of the leading lifecycle quality management, regulatory information, or ERP systems is required.

Ability to think critically, and demonstrated troubleshooting, problem-solving, and risk assessment skills.

Strategic thinking and high emotional intelligence.

Excellent interpersonal, verbal, and written communication skills.

Ability to function efficiently and independently in a changing environment.

Manage and advance multiple projects simultaneously and dynamically reprioritize as needed.

Demonstrated capacity to think creatively when addressing complex situations.

Ability to communicate effectively with Kyverna Leadership, clinical, biomarker, biostatistical, and pre-clinical scientists, and with external business partners and Regulatory Authorities.

Benefits

Bonus

Benefits

Participation in Company’s stock option plan

Company

Kyverna Therapeutics

Kyverna Therapeutics is pioneering a new class of therapies and cures for serious autoimmune diseases.

Founded in 2018

Berkeley, California, USA

51-200 employees

http://kyvernatx.com

H1B Sponsorship

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