Exel
Associate QA Operations Director - Systems and Process
Alameda, CA · Director
Sponsorship not specified$176k-$251kDetected 26 days ago
Supply ChainFDA RegulatoryCommunicationCollaborationPublic SpeakingGxPRegulatory Affairs
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
- Demonstrate strong time-management and organizational ability to analyze and improve processes and consistently produce high quality work
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.
- Knowledge, Skills and Abilities
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.