Exel
Associate QA Operations Director - Systems and Process
Alameda, CA · Director
Stay score
odds of building a lasting career here
Sponsors, but it's cap-subject — you still face the weighted lottery (~61% per draw at Level IV). Good if you win; have a cap-exempt backup on your list.
Lottery odds assume a STEM candidate.
Personalize to your clock →H-1B wage level
the lottery is wage-weighted — each level is one more entry
$758 more — $176,758 — moves this role to Level III and 3 lottery entries. That figure is inside the range the employer already advertised.
Based on the DOL prevailing wage for this occupation and worksite, a base salary of $176,758 would place this position at wage Level III. That figure is within the posted range, and I'd like to target it. This role classifies under "General and Operations Managers" for prevailing-wage purposes.
DOL prevailing wage, 2026-27 wage year · General and Operations Managers (11-1021) · San Francisco-Oakland-Fremont, CA. Wage level is derived by USCIS from the offered wage, occupation and worksite; the occupation shown is inferred from the job title.
Employer immigration record
from this employer's Department of Labor filings
Files H-1B transfers
Sourced from Department of Labor LCA, PERM and prevailing-wage disclosure data. Employer matching is by name, so figures may be split across an employer's legal entities. Absence of a filing means none appears in our copy of the data, not that none exists.
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About the role
- Demonstrates a high level of independent quality judgment and acumen.
- The base pay range for this position is $176,000 - $250,500 annually.
- The base pay range may take into account the candidate's geographic region, which will adjust the pay depending on the specific work location.
Responsibilities
- Lead and Partner QA support for Deviations, Change Control, CAPA, CAPA Actions and Effectiveness checks management.
- Execute clinical and commercial artwork and labelling review and approval, including oversight of vendors; resolve quality issues. Deliver on company core objectives in a timely manner, per supply plan, and drive for results.
- Lead process and system improvement.
- Responsible for generating a risk-based strategy across the GxP landscape to identify and manage issues and risks while driving continuous improvement, to ensure compliance with global regulatory standards and align with key stakeholders.
- Establish and maintain strong collaborative relationships with internal and external stakeholders to ensure timely documentation, escalation and resolution of quality issues.
- Manage conflict by engaging teams to address issues, seeking diverse views and facilitating identification of options to achieve an equitable solution.
- The Associate QA Operations Director - Systems and Process is accountable for providing QA lead support for Quality Systems (Deviations, Change Control, CAPA, etc.), As a Partner responsible for guiding the organization in the successful, thorough, and timely execution of complex Quality Events (Deviations, Change Requests, CAPA's, CAPA Actions, Change Actions, Effectiveness Checks, etc.).
- Partners closely with QA and cross-functionally with Pharmaceutical Supply Chain (PSC), Clinical Development/Operations, Information technology (IT), Regulatory Affairs (RA), Global Patient Safety, etc.) as needed to identify, mitigate, escalate, and resolve issues and risks.
- This role supports development, generation, review, and approval of clinical and commercial artwork and labeling.
- Drive results and influences others outside of direct authority.
Requirements
- It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.
Skills
- Equivalent combination of education and experience.
- Experience in pharmaceutical or biotech industries, and packaging/labeling is preferred.
- Experience in development of business strategies, metrics, and continuous improvements is preferred.
- Demonstrated knowledge of cGMPs, Health Authority Regulations, Quality Systems and manufacturing processes.
- International/global regulatory requirements experience preferred.
- Experience with participation in regulatory inspections and audits, presenting or defending functions.
- Understands technical information related to equipment, processes, and regulatory expectations
- Demonstrate strong time-management and organizational ability to analyze and improve processes and consistently produce high quality work
Compensation
- The base pay range for this position is $176,000 - $250,500 annually.
- The base pay range may take into account the candidate's geographic region, which will adjust the pay depending on the specific work location.
Benefits
- SME for Health Authority inspections and audits.
This listing is sourced directly from Exel's careers page and normalized into a canonical job model.