GSMS, Incorporated · 1 day ago
Quality & Compliance Manager
Camarillo, CA
Full-time
Onsite
Senior Level, Lead/Staff
$85K/yr - $115K/yr
8+ years expGSMS, Incorporated is seeking a Quality & Compliance Manager to lead the development and execution of supplier quality management and internal audit programs. This role is responsible for overseeing supplier qualification, compliance with FDA regulations, and managing the CAPA program to ensure high-quality standards are met.
BiotechnologyHealth CarePharmaceuticalRobotics
Responsibilities
Responsible for the development and execution of the supplier quality management program and processes for GMP suppliers
Manage the quality of drug product, raw material, and GMP service suppliers to ensure GSMS and FDA requirements are met
Qualify new suppliers per GSMS policies and procedures
Negotiate, approve and manage quality agreements between GSMS and suppliers
Participate on a cross functional supplier management team with colleagues from Supply Chain, Purchasing, and Commercial Operations to assess, communicate, and manage supplier performance via scorecards and business meetings
Develop and maintain supplier risk ranking including evaluating internal and supplier Preventive Controls
Oversee the Supplier Change Notification (SCN) process, ensuring GSMS is notified of supplier changes and GSMS processes & procedures are thoroughly assessed and updated as required
Work collaboratively with suppliers and GSMS Quality teams on Supplier Corrective Action Request (SCAR) process, ensuring effective corrective actions are being taken by suppliers
Develop and maintain a current and accurate database of supplier quality management information such as Supplier History File, Approved Vendor List (AVL), risk analysis results, supplier performance, etc
Develop and manage GSMS external and internal audit programs
Oversee and conduct external and internal audits, ensuring any improvements or corrective actions are addressed to GSMS’s satisfaction
Manage GSMS CAPA program. Lead CAPA meetings and monitor timeliness & effectiveness of correction actions
Helps drive a culture of continuous improvement
Assist with leading regulatory and 3rd party inspections and audits, including pre-inspection readiness, inspection execution, and post inspection responses
Performs other quality and compliance-related duties as assigned
Qualification
Required
Minimum 8+ years in pharmaceutical operations required
Strong knowledge of FDA GMP regulations, practices and trends
Working knowledge of pharmaceutical processing and manufacturing processes
Strong communication skills at all levels, both written and verbal; both individually and in a group setting
Strong leadership, negotiation and influencing skills
Strong skills in analytical thinking and problem solving
Proficiency in audit planning, execution, and reporting
Ability to translate complex data into actionable information
Ability to evaluate complex compliance issues and concerns
Ability to perform multiple tasks and ability to effectively manage conflict
Ability to work in teams to obtain results
Good decision-making skills. Ability to make decisions with limited information
Proactively identify issues and take action
Effectively manage change and comfortable changing direction and acting without complete information
Good organizational and prioritization skills
May be required to work longer than the typical 8-hour work day
Sedentary position that may require prolonged long periods of desk work
Requires light physical duties in keeping work areas clean and organized. Regularly required to walk the production and warehouse areas
Required working knowledge of basic Microsoft Office applications
Working knowledge of data analysis software and reporting
Must be able to pass screening, drug test and background check. Adhere to company's drug-free workplace policies
Travel 25-30% domestic to supplier locations
Must be enthusiastic, concerned with job and company as whole, openness with management, and punctual
Self-discipline and a desire to achieve results
Must be detail-oriented
Team player, professional, and achieve high quality results
Preferred
Bachelor's degree preferred, health sciences preferred
Benefits
A full range of other health and welfare benefits
Company
GSMS, Incorporated
Golden State Medical Supply (GSMS) is a leading pharmaceutical provider with a mission to improve the lives of those who receive our products.
201-500 employees
Funding
Current Stage
Growth StageTotal Funding
unknown2015-01-01Series Unknown
Leadership Team
Anita Wrublevski
Senior VP Government Sales
Recent News
New Enterprise Associates
2026-01-02
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