New · posted Oct 15
Viking Therapeutics · Pharmaceuticals
Manager, GMP Quality Operations
- San Diego, CA
- On-site
- Full-time
- Manager
Open until filled
The role
Description
The Manager, GMP Quality Operations is responsible for day-to-day Quality oversight of GMP manufacturing and testing activities across Viking’s external manufacturing network, supporting late-stage clinical development and future commercial programs.
The Manager will work closely with Viking Quality, Technical Operations/CMC, Regulatory Affairs, Supply Chain, and external CDMOs to ensure manufacturing, testing, and release activities are executed in compliance with cGMP requirements, Quality Agreements, and Viking quality standards.
This role will provide hands-on Quality Operations support across drug substance, drug product, and combination-product manufacturing activities, including batch record review and disposition, deviation and investigation management, change control, technology transfer, process validation/PPQ, and inspection readiness.
This is an onsite role based in San Diego, CA, with periodic travel to domestic and international CDMOs as required.
Travel: ~25%
What you need
Education and Experience Requirements
- Bachelor’s degree in Life Sciences, Chemistry, Engineering, or a related discipline.
- 7+ years of progressive experience in GMP Quality Operations within pharmaceutical or biotechnology organizations.
Knowledge and Skills Requirements
- Hands-on experience supporting external manufacturing/CDMO operations strongly preferred.
- Experience supporting late-stage clinical development and/or commercial manufacturing environments preferred.
- Demonstrated experience with GMP batch record review, investigations, deviations, CAPA, change control, and product disposition.
- Experience with technology transfer, process validation/PPQ, and manufacturing scale-up activities preferred.
- Experience with small-molecule drug substance and/or drug product manufacturing.
- Experience with one or more of the following is highly desirable: Sterile injectable manufacturing, including prefilled syringes and vials, Solid oral dosage forms, Drug-device combination products, including autoinjectors
- Experience interfacing with Qualified Persons (QPs) and/or global product-release functions is desirable.
- Working knowledge of applicable global GMP regulations and guidance, including FDA, EMA, and ICH requirements.
- Strong ability to review complex GMP documentation and identify quality, compliance, and product-impact risks.
- Demonstrated ability to work effectively with external CDMOs and cross-functional internal teams without direct authority.
- Strong organizational and project-management skills with the ability to manage multiple priorities and meet aggressive timelines.
- Excellent written and verbal communication skills and the ability to communicate and escalate quality risks effectively.
What you'll do
Essentials Duties and Responsibilities
The main responsibilities of this role include:
- Manage external Quality Operations activities in support of GMP manufacturing for clinical and future commercial programs.
- Manage deviations, OOS/OOT investigations, and CAPAs in accordance with cGMP requirements and ICH guidelines.
- Review and approve GMP documentation, including batch records, analytical and technical reports, and Quality/CMC documentation supporting regulatory submissions (e.g., IND/IMPD and NDA/MAA).
- Provide QA support for technology transfer and process validation activities.
- Perform disposition of GMP batches and interface with Qualified Persons (QPs) and CDMO Quality organizations to support product release.
- Manage change controls to ensure appropriate evaluation of manufacturing- and testing-related changes by Quality, Regulatory Affairs, and relevant subject matter experts.
- Support management of CDMO quality performance in accordance with Quality Agreements and GMP requirements.
- Drive continuous improvement and inspection readiness activities.
- Collaborate cross-functionally to support pre-approval inspection and commercial readiness activities at CDMOs.
- Participate in compliance discussions and support the resolution of quality issues and implementation of required corrective actions.
- Foster a culture of collaboration, accountability, and operational excellence across internal and external teams.
- Perform additional tasks as assigned
Pay
$110,000 – $135,000 a year
Employer providedSalary Description
$110,000.00 - $135,000.00 annual salary
Where 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 · October 15, 2026
Salary intelligence
How the pay compares
This role's midpoint is 20% below the US median for Quality Assurance roles at this level.
This roleEmployer provided
Manager roles in California25 roles publishing pay
Manager roles in the US105 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $110,000 | — | $135,000 |
| California (middle half) | $156,000 | $165,500 | $181,000 |
| All US (middle half) | $126,000 | $153,000 | $167,500 |
This role: Viking Therapeutics's own published range. Comparisons: the base pay employers published on open Quality Assurance roles at the same level on Regulatory Jobs, October 15, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Assurance
The general path across 845 open Quality Assurance roles on Regulatory Jobs, with the titles they carry most. Not Viking Therapeutics's own promotion track.
Career resources on Quality Assurance
Skills DNA
What this role leans on
How many of the posting's 33 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- GMP and compliance15
- Lab testing and methods4
- Documentation and SOPs4
- Quality systems and risk4
- Collaboration and leadership4
- Investigations and CAPA3
- Validation and qualification3
- Regulatory submissions1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
- FDA21 CFR Parts 210 and 211(official source, opens in a new tab)FDA current good manufacturing practice for finished pharmaceuticals
- FDAFDA OOS guidance(official source, opens in a new tab)Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production
- FDAFDA process validation guidance(official source, opens in a new tab)Process Validation: General Principles and Practices
- ICHICH quality guidelines(official source, opens in a new tab)Q1 stability, Q2(R2) analytical validation, Q7, Q9 risk management, Q10 quality systems
- European CommissionEU GMP (EudraLex Volume 4)(official source, opens in a new tab)The EU's good manufacturing practice rules and annexes
- FDAFDA IND(official source, opens in a new tab)Investigational New Drug applications
Company hiring pulse
Viking Therapeutics on Regulatory Jobs
- 2
- Open roles
- 2
- Distinct roles
- 1
- Locations
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Manager, GMP Quality Operations at Viking Therapeutics
Open until filled. $110K–$135K a year, employer provided.