Quality Management Systems Manager (QMS Manager)

Description

The Quality Management Systems Manager (QMS Manager), will work cross-functionally to drive and champion projects related to continuous improvement of the systems, processes, and functions comprising the GxP Quality Management System (QMS) on Veeva Basic platform, while ensuring compliance with regulatory requirements, industry standards, and company policies in support of the development, manufacturing, testing, release, and distribution of pharmaceutical and device products (clinical and commercial). Provide expertise on the quality systems and associated processes operating across the regulated environment. Coordinate and guide material and change control review boards, ability to understand and evaluate process and system risks.

Essential Duties and Responsibilities

The main responsibilities of this role include:

• •Identify, champion, and drive cross-functional improvement initiatives to enhance and streamline quality systems, frameworks, and associated processes, i.e. material and change control review boards.
• •Facilitate stakeholder engagement to ensure quality systems are continuously monitored and improved to strengthen compliance and operational efficiency.
• •Plan, coordinate, and lead internal audit activities, including preparation, execution, response coordination, and follow-up of observations.
• •Coordinate partner response development, and overseeing commitments, investigations and CAPAs.
• •Develop, review, and approve a variety of controlled documents in alignment with regulatory requirements, relevant guidance, and company standards.
• •Facilitate quality management reviews and support the development of registers, KPIs, metrics, and dashboards as well as mechanisms for routine reporting.
• •Apply project management and execution methodologies to prioritize, plan, and deliver quality system and compliance initiatives in collaboration with stakeholders.
• •Monitor evolving regulatory requirements and guidance, and partner with stakeholders to assess and address potential impacts to the quality system.
• •Foster a culture of quality, collaboration, and accountability within the team and across the organization.
• •Perform additional duties as requested.

Requirements

Education and Experience

• •Bachelor's degree in life sciences, pharmacy, chemistry, or related field.
• •Minimum of eight (8) years of experience in the regulated pharmaceutical and/or biotechnology industry, in which at least five (5) of those years were in a leadership position with increasing levels of responsibility.
• •Hands-on, expert level experience with full Veeva Vault or Veeva Basics implementations, ideally within the Vault Quality Suite (QualityDocs, QMS, Training)
• •Veeva Vault Administrator or Vault Quality certification (a plus)

Knowledge and Skills

• •Full knowledge of GxP regulations, including GMP (FDA, EU, etc.), ICH guidelines, and ISO standards.
• •Experience working with global teams and regulated environments
• •Experience in managing enhancements post-implementation and supporting continuous improvement
• •Demonstrated skills in the areas of project management, organization, and execution as well as priority setting.
• •Proven experience developing and/or improving QMS, QE, and compliance programs, to include leading material and change control review boards.
• •Highly motivated, strategic thinker with a focus on continuous improvement and innovation, who endeavors to anticipate and resolve problems.
• •Excellent communication, interpersonal, and leadership skills, with the ability to work with a diverse range of professionals and influence stakeholders at all levels.
• •Extensive experience with the use of electronic document / quality management systems (EMDS / EQMS)
• •Attention to detail and ability to manage multiple priorities

VIKING THERAPEUTICS

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.

Notice to Agency and Search Firm Representatives

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. #LI-DNI