Exel
Associate QA Systems and Process QMS Director
Alameda, CA · Director
Sponsorship not specified$176k-$251kDetected 7 days ago
Supply ChainFDA RegulatoryCommunicationCollaborationPublic SpeakingGxPRegulatory Affairs
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odds of building a lasting career here
61Sponsors, lottery-bound
Cap-exempt (no lottery)0
Sponsors this role90
Entry-level history0
PERM / green-card track0
Lottery odds (Level IV)94
Fits your clock70
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 →Employer immigration record
from this employer's Department of Labor filings
Green-card filing pattern in this occupation
Context, not a finding about this posting: of this employer's 3 green-card filings in this occupation, 100% were for a worker who already held the job.
Files H-1B transfers
1 transfer filing in the last year, covering 1 worker. Median labor-condition decision: 9 days. An employer that already files transfers is one that can take over an existing H-1B.
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
- The base pay range for this position is $176,000 - $251,000 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.
- The base pay offered will take into account the candidate's geographic region, job-related knowledge, skills, experience and internal equity, among other factors.
Responsibilities
- Champion and Partner QA support for QMS (Deviations, Change Control, CAPA, CAPA Actions, Effectiveness checks, etc.).
- Owns business process for eQMS.
- As a Change Control Process owner and QMS Business owner, drive cross-functional compliance, provide QMS guidance, ensure complete, thorough and timely completion of quality records.
- Own governing procedures and drive continuous improvement to ensure fit-for-purpose, risk based QMS processes.
- Develop and chamption a risk-based strategy across the GxP landscape to identify, manage, and mitigate risks; address potential blind spots; escalate issues; propose solutions; drive continuous improvement; and ensure alignment with key stakeholders and global regulatory standards.
- Own continuous improvements of the eQMS platform and Computer System Validation (CSV) processes to enhance efficiency, compliance, and overall system effectiveness.
- Manage conflict by actively engaging teams to address issues, seeking diverse views and facilitate identification of options to achieve an equitable solution.
- Drive results and influence others outside of direct authority.
- The Associate QA Systems and Process QMS Director is the QA lead accountable for providing organizational guidance, support and act as business owner for Quality Management Systems (QMS), to ensure a fit-for-purpose, compliant and timely execution of complex Quality Events (Change Requests, Change Actions, Deviations, CAPAs, Effectiveness Checks, Issue Escalations, etc.).
- This role owns continuous QMS improvement by leading process enhancements, delivering training, reporting metrics, and serving as the system Business Owner.
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 applicable experience.
- Experience in pharmaceutical or biotech industries, and Quality Systems 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 - $251,000 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
- Serve as the SME for health authority inspections and audits, while fostering strong relationships with internal and external stakeholders to ensure timely documentation, escalation, and resolution of quality issues.
This listing is sourced directly from Exel's careers page and normalized into a canonical job model.