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Lead the Quality Systems team to develop and maintain a scalable QMS compliant with GMP and FDA standards for clinical and commercial operations. Oversee document lifecycles, manage regulatory inspections, and drive quality risk management across the product lifecycle.
Requires a Bachelor's degree in Life Sciences or Engineering with over 10 years of QA experience, including 5 years in a leadership role. Must possess deep expertise in eQMS platforms like Veeva and comprehensive knowledge of FDA and ICH regulatory requirements.
Description
The Director Quality Systems will lead and support quality assurance and quality systems activities for Viking’s clinical and commercial-stage operations. The role advances the company's Quality Management System, drives inspection readiness, and ensures quality processes are scalable, compliant, and aligned with late-stage development and commercial launch. The ideal candidate brings hands-on QA and Quality Systems experience, deep knowledge of GMP and FDA requirements, and a proven ability to partner cross-functionally to build a proactive, risk-based quality culture.
The main responsibilities of this role include:
Requirements
Viking Therapeutics, Inc., is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Viking Therapeutics also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA.
Viking Therapeutics, Inc. is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Viking employee by a third-party agency and/or search firm without a valid written & signed search agreement, and assignment of specific position, will become the sole property of Viking Therapeutics, Inc. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral.
Salary Description
$170,000.00 - $210,000.00 annual salary
Viking Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on the development of novel first-in-class or best-in-class therapies for the treatment of metabolic and endocrine disorders. Viking's research and development activities leverage its expertise in metabolism to develop innovative therapeutics designed to improve patients' lives. Viking's clinical programs include VK2735, a novel dual agonist of the glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptors for the potential treatment of various metabolic disorders. The company is evaluating its subcutaneous formulation of VK2735 in a Phase 3 obesity program that includes two Phase 3 clinical trials (VANQUISH-1 and VANQUISH-2). Data from a Phase 1 and a Phase 2 trial evaluating subcutaneous VK2735 demonstrated an encouraging safety and tolerability profile as well as positive signs of clinical benefit. Concurrently, the company is evaluating an oral formulation of VK2735 in obesity. Viking is also developing VK2809, a novel, orally available, small molecule selective thyroid hormone receptor beta agonist for the treatment of lipid and metabolic disorders. The compound successfully achieved both the primary and secondary endpoints in a Phase 2b study for the treatment of biopsy-confirmed non-alcoholic steatohepatitis (NASH) and fibrosis. The company's newest program is evaluating a series of internally developed dual amylin and calcitonin receptor agonists (or DACRAs) for the treatment of obesity and other metabolic disorders. In the rare disease space, Viking is developing VK0214, a novel, orally available, small molecule selective thyroid hormone receptor beta agonist for the potential treatment of X-linked adrenoleukodystrophy (X-ALD).
Offices: 9920 Pacific Heights Blvd,, Suite 350, San Diego, California 92121, US
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