New · posted Nov 10
Viking Therapeutics · Biotechnology
Quality Management Systems Manager (QMS Manager)
- San Diego, CA
- On-site
- Full-time
- Manager
The role
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.
What you need
- 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
What you'll do
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.
Pay
$120,000 – $140,000 a year
Employer providedWhere you'll work
San Diego, CAOn-siteOpen in Maps (opens in a new tab)
More jobs in San Diego, CAEqual opportunity, accessibility and legal noticesViking Therapeutics's statements, word for word
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
Job intelligence
The context around this role
Live data · November 10, 2026
Salary intelligence
How the pay compares
This role's midpoint is 18% below the US median for Quality Systems & Document Control roles at this level.
This roleEmployer provided
Manager roles in California9 roles publishing pay
Manager roles in the US18 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $120,000 | — | $140,000 |
| California (middle half) | $159,000 | $165,500 | $181,000 |
| All US (middle half) | $140,125 | $159,250 | $169,250 |
This role: Viking Therapeutics's own published range. Comparisons: the base pay employers published on open Quality Systems & Document Control roles at the same level on Regulatory Jobs, November 10, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Systems & Document Control
The general path across 91 open Quality Systems & Document Control roles on Regulatory Jobs, with the titles they carry most. Not Viking Therapeutics's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 26 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Quality systems and risk11
- Collaboration and leadership11
- GMP and compliance6
- Data and digital systems3
- Lab testing and methods2
- Documentation and SOPs2
- Investigations and CAPA1
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Quality Systems & Document Control work in biotechnology, led by the one this posting names, each linked to the agency or standards body that publishes it.
- FDA21 CFR Parts 210 and 211(official source, opens in a new tab)FDA current good manufacturing practice for finished pharmaceuticalsNamed in the posting
- ICHICH Q10(official source, opens in a new tab)The pharmaceutical quality system across the product lifecycle
- FDA21 CFR Part 11(official source, opens in a new tab)FDA rules for electronic records and electronic signatures
- FDAFDA data integrity guidance(official source, opens in a new tab)Data Integrity and Compliance With Drug CGMP: Questions and Answers
- ISOISO 19011(official source, opens in a new tab)Guidelines for auditing management systems
- FDA21 CFR 314.70(official source, opens in a new tab)Supplements and other changes to an approved application (post-approval CMC changes)
- HHS-OIGHHS-OIG General Compliance Program Guidance(official source, opens in a new tab)The federal government's guide to healthcare compliance programs and the anti-kickback statute
- ICHICH Q9(R1)(official source, opens in a new tab)Quality risk management
- EUEU GMP (EudraLex Volume 4)(official source, opens in a new tab)The EU's good manufacturing practice rules, including Annex 1 sterile and Annex 15 validation
- ISPEISPE GAMP 5(official source, opens in a new tab)A risk-based approach to compliant GxP computerized systems
- FDAFDA quality agreements guidance(official source, opens in a new tab)Contract Manufacturing Arrangements for Drugs: Quality Agreements
- FDA21 CFR Part 7(official source, opens in a new tab)FDA enforcement policy, including product recalls
- FDAFDA Investigations Operations Manual(official source, opens in a new tab)How FDA investigators plan and conduct inspections
- PIC/SPIC/S(official source, opens in a new tab)The Pharmaceutical Inspection Co-operation Scheme and its GMP guide
- ICHICH Q7(official source, opens in a new tab)Good manufacturing practice for active pharmaceutical ingredients
- FDA21 CFR Parts 600 to 680(official source, opens in a new tab)FDA standards for biological products, from licensing to lot release
Company hiring pulse
Viking Therapeutics on Regulatory Jobs
- 7
- Open roles
- 7
- Distinct roles
- 1
- Locations
By discipline
- Clinical4 57%
- Quality2 29%
- Regulatory1 14%
By level
- Manager3 43%
- Director2 29%
- Senior & Principal1 14%
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Quality Management Systems Manager (QMS Manager) at Viking Therapeutics
Open until filled. $120K–$140K a year, employer provided.